Trial Outcomes & Findings for A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis (NCT NCT03158285)

NCT ID: NCT03158285

Last Updated: 2022-12-22

Results Overview

ACR 20 response: \>=20% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and \>=20% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of Health Assessment Questionnaire (HAQ-DI; 20-question instrument assessing 8 functional areas; range: 0-3, 0= no difficulty, 3= inability to perform task in that area), and CRP. Treatment Failure (TF) criteria- discontinued study drug, initiated/increased dose of non-biologic disease-modifying antirheumatic drugs (DMARDs) or oral corticosteroids, initiated prohibited psoriatic arthritis treatment.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 741 participants
• Primary outcome timeframe: Week 24
• Results posted on: 2022-12-22

Participant Flow

A total of 741 participants were randomized and 739 participants received at least one dose of study drug: 246 in placebo group, 248 in guselkumab 100 mg q8w group, and 245 in guselkumab 100 mg q4w group. Two participants were randomized in error and were never treated. Disposition is presented till active treatment period (Week100).

Participant milestones

Measure	Placebo to Guselkumab 100 mg q4w Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Placebo-controlled Period: Week 0 - 24 STARTED	246	248	245
Placebo-controlled Period: Week 0 - 24 Pooled Population: Enthesitis Assessment	255	230	243
Placebo-controlled Period: Week 0 - 24 Pooled Population: Dactylitis Assessment	154	160	159
Placebo-controlled Period: Week 0 - 24 COMPLETED	240	240	236
Placebo-controlled Period: Week 0 - 24 NOT COMPLETED	6	8	9
Active Treatment Period: Week 24 - 52 STARTED	238	240	234
Active Treatment Period: Week 24 - 52 COMPLETED	228	234	227
Active Treatment Period: Week 24 - 52 NOT COMPLETED	10	6	7
Active Treatment Period: Week 52-100 STARTED	228	232	227
Active Treatment Period: Week 52-100 COMPLETED	210	223	219
Active Treatment Period: Week 52-100 NOT COMPLETED	18	9	8

Reasons for withdrawal

Measure	Placebo to Guselkumab 100 mg q4w Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Placebo-controlled Period: Week 0 - 24 Adverse Event	4	2	6
Placebo-controlled Period: Week 0 - 24 Lack of Efficacy	0	3	3
Placebo-controlled Period: Week 0 - 24 Withdrawal by Subject	1	1	0
Placebo-controlled Period: Week 0 - 24 Lost to Follow-up	0	1	0
Placebo-controlled Period: Week 0 - 24 Other	1	1	0
Active Treatment Period: Week 24 - 52 Adverse Event	3	0	1
Active Treatment Period: Week 24 - 52 Lack of Efficacy	5	3	4
Active Treatment Period: Week 24 - 52 Withdrawal by Subject	1	2	1
Active Treatment Period: Week 24 - 52 Pregnancy	0	0	1
Active Treatment Period: Week 24 - 52 Other	1	1	0
Active Treatment Period: Week 52-100 Adverse Event	7	5	3
Active Treatment Period: Week 52-100 Lack of Efficacy	1	1	3
Active Treatment Period: Week 52-100 Withdrawal by Subject	5	2	1
Active Treatment Period: Week 52-100 Pregnancy	0	0	1
Active Treatment Period: Week 52-100 Death	1	0	0
Active Treatment Period: Week 52-100 Other	4	1	0

Baseline Characteristics

A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis

Baseline characteristics by cohort

Measure	Placebo to Guselkumab 100 mg q4w n=246 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=248 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=245 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.	Total n=739 Participants Total of all reporting groups
Age, Continuous	46.3 years STANDARD_DEVIATION 11.68 • n=5 Participants	44.9 years STANDARD_DEVIATION 11.89 • n=7 Participants	45.9 years STANDARD_DEVIATION 11.47 • n=5 Participants	45.7 years STANDARD_DEVIATION 11.68 • n=4 Participants
Sex: Female, Male Female	129 Participants n=5 Participants	119 Participants n=7 Participants	103 Participants n=5 Participants	351 Participants n=4 Participants
Sex: Female, Male Male	117 Participants n=5 Participants	129 Participants n=7 Participants	142 Participants n=5 Participants	388 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	245 Participants n=5 Participants	247 Participants n=7 Participants	245 Participants n=5 Participants	737 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	8 Participants n=7 Participants	3 Participants n=5 Participants	15 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	242 Participants n=5 Participants	240 Participants n=7 Participants	242 Participants n=5 Participants	724 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment BULGARIA	14 participants n=5 Participants	9 participants n=7 Participants	6 participants n=5 Participants	29 participants n=4 Participants
Region of Enrollment CZECH REPUBLIC	13 participants n=5 Participants	5 participants n=7 Participants	15 participants n=5 Participants	33 participants n=4 Participants
Region of Enrollment ESTONIA	5 participants n=5 Participants	8 participants n=7 Participants	5 participants n=5 Participants	18 participants n=4 Participants
Region of Enrollment LATVIA	3 participants n=5 Participants	3 participants n=7 Participants	0 participants n=5 Participants	6 participants n=4 Participants
Region of Enrollment LITHUANIA	8 participants n=5 Participants	8 participants n=7 Participants	4 participants n=5 Participants	20 participants n=4 Participants
Region of Enrollment MALAYSIA	3 participants n=5 Participants	6 participants n=7 Participants	3 participants n=5 Participants	12 participants n=4 Participants
Region of Enrollment POLAND	35 participants n=5 Participants	27 participants n=7 Participants	23 participants n=5 Participants	85 participants n=4 Participants
Region of Enrollment RUSSIAN FEDERATION	92 participants n=5 Participants	77 participants n=7 Participants	104 participants n=5 Participants	273 participants n=4 Participants
Region of Enrollment SPAIN	3 participants n=5 Participants	12 participants n=7 Participants	4 participants n=5 Participants	19 participants n=4 Participants
Region of Enrollment TAIWAN	0 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants
Region of Enrollment TURKEY	2 participants n=5 Participants	8 participants n=7 Participants	6 participants n=5 Participants	16 participants n=4 Participants
Region of Enrollment UKRAINE	65 participants n=5 Participants	83 participants n=7 Participants	73 participants n=5 Participants	221 participants n=4 Participants
Region of Enrollment UNITED STATES	3 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants	6 participants n=4 Participants

PRIMARY outcome

Timeframe: Week 24

Population: Analysis population is full analysis set 1 (FAS1). Participants who achieved ACR 20 response at Week 24 and did not meet any treatment failure (TF) criteria before Week 24 were considered as responders. Participants who met 1 or more TF criteria or with missing data were considered as non-responders.

ACR 20 response: >=20% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=20% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of Health Assessment Questionnaire (HAQ-DI; 20-question instrument assessing 8 functional areas; range: 0-3, 0= no difficulty, 3= inability to perform task in that area), and CRP. Treatment Failure (TF) criteria- discontinued study drug, initiated/increased dose of non-biologic disease-modifying antirheumatic drugs (DMARDs) or oral corticosteroids, initiated prohibited psoriatic arthritis treatment.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=246 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=248 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=245 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24	32.9 percentage of participants	64.1 percentage of participants	63.7 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Analysis population is FAS1. Data after meeting one or more TF criteria were imputed as no change from baseline. Missing data were assumed to be missing at random (MAR) and imputed using multiple imputation (MI).

HAQ-DI score assess functional status of participant. It is 20 question instrument that assess degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0=indicating no difficulty, to 3=indicating inability to perform a task in that area. Total HAQ score is average of the computed categories scores ranging from 0-3 where 0=least difficulty and 3=extreme difficulty. Lower scores are indicative of better functioning. Negative change from baseline indicates improvement of physical function.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=246 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=248 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=245 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24	-0.1300 units on a scale Interval -0.1912 to -0.0687	-0.3672 units on a scale Interval -0.4282 to -0.3062	-0.4004 units on a scale Interval -0.4617 to -0.339

SECONDARY outcome

Timeframe: Week 24

Population: Analysis population is FAS1. Participants who achieved ACR 50 response at Week 24 and did not meet any TF criteria before Week 24 were considered as responders. Participants who met 1 or more TF criteria or with missing data were considered as non-responders.

ACR 50 response was defined as greater than or equal to (>=)50 percent (%) improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=50% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and C-Reactive Protein (CRP).

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=246 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=248 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=245 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved an ACR 50 Response at Week 24	14.2 percentage of participants	31.5 percentage of participants	33.1 percentage of participants

SECONDARY outcome

Timeframe: Week 24

Population: FAS1 among participants with \>=3% BSA psoriatic involvement and an IGA score \>=2 (mild) at baseline. Participants who achieved psoriasis IGA response at Week 24 and did not meet any TF criteria before Week 24 were considered as responders. Participants who met 1 or more TF criteria or with missing data were considered as non-responders.

A psoriasis Investigator's Global Assessment (IGA) response was defined as an IGA score of 0 (cleared) or 1 (minimal) and >=2 grade reduction from baseline in the IGA psoriasis score. The IGA documents the investigator's assessment of the patient's psoriasis and lesions are graded for induration, erythema and scaling, each using a 5 point scale: 0 (no evidence), 1 (minimal), 2 (mild), 3 (moderate), and 4 (severe). The IGA score of psoriasis was based upon the average of induration, erythema and scaling scores. The participant's psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=183 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=176 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=184 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved Psoriasis Response With IGA Score of 0 (Cleared) or 1 (Minimal) and >=2 Grade Reduction From Baseline at Week 24 Among Participants With >=3% BSA Psoriatic Involvement and IGA Score of >=2 (Mild) at Baseline	19.1 percentage of participants	70.5 percentage of participants	68.5 percentage of participants

SECONDARY outcome

Timeframe: Week 16

Population: Analysis population is FAS1. Participants who achieved ACR 20 response at Week 16 and did not meet any TF criteria before Week 16 were considered as responders. Participants who met 1 or more TF criteria before Week 16 or with missing data were considered as non-responders.

ACR 20 response was defined as >= 20% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=20% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=246 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=248 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=245 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 16	33.7 percentage of participants	55.2 percentage of participants	55.9 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: FAS1 for structural damage (FAS1-SD) included all participants who received at least 1 dose (complete/partial) of study agent according to randomized treatment group regardless of treatment actually received. Observed data were used regardless if 1 or more TF criteria were met. Missing data were assumed to be MAR and imputed using MI.

Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=246 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=248 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=245 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in Modified Van Der Heijde-Sharp (vdH-S) Score at Week 24	0.95 units on a scale Interval 0.61 to 1.29	0.52 units on a scale Interval 0.18 to 0.86	0.29 units on a scale Interval -0.05 to 0.63

SECONDARY outcome

Timeframe: Week 24

Population: FAS1 among participants with enthesitis at baseline pooled from CNTO1959PSA3001 (NCT03162796) and CNTO1959PSA3002 (NCT03158285) studies. Participants with enthesitis resolution at Week 24 and did not meet any TF criteria before Week 24 considered responders. Participants who met 1/more TF criteria or with missing data considered non-responders.

Enthesitis was assessed using the Leeds Enthesitis Index (LEI), a tool developed to assess enthesitis in participants with PsA and evaluates the presence (score of 1) or absence (score of 0) of pain by applying local pressure to the following entheses: left and right lateral epicondyle humerus, left and right medial femoral condyle, and left and right achilles tendon insertion. The enthesitis index score is a total score of the 6 evaluated sites from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). A LEI score of 0 at a post baseline visit indicates resolution of enthesitis when baseline LEI>0. The outcome measure was planned to be reported for pooled population from CNTO1959PSA3001 and CNTO1959PSA3002 studies.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=255 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=230 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=243 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants With Resolution of Enthesitis at Week 24 Among the Participants With Enthesitis at Baseline	29.4 percentage of participants	49.6 percentage of participants	44.9 percentage of participants

SECONDARY outcome

Timeframe: Week 24

Population: FAS1 among participants with dactylitis at baseline pooled from CNTO1959PSA3001 (NCT03162796) and CNTO1959PSA3002 (NCT03158285) studies. Participants with dactylitis resolution at Week 24 and did not meet any TF criteria before Week 24 considered responders. Participants who met 1/more TF criteria or with missing data considered non-responders.

The presence and severity of dactylitis was assessed in both hands and feet using a scoring system from 0 to 3 (0-no dactylitis, 1-mild dactylitis, 2-moderate dactylitis, and 3-severe dactylitis) for each digit. The results were summed to produce a final score ranging from 0 to 60. Higher score indicates more severe dactylitis. Resolution of dactylitis was defined as a dactylitis score of 0 with the baseline dactylitis score >0. The outcome measure was planned to be reported for pooled population from CNTO1959PSA3001 and CNTO1959PSA3002 studies.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=154 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=160 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=159 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants With Resolution of Dactylitis at Week 24 Among the Participants With Dactylitis at Baseline	42.2 percentage of participants	59.4 percentage of participants	63.5 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Analysis population is FAS1 among participants with enthesitis at baseline pooled from both CNTO1959PSA3001 (NCT03162796) and CNTO1959PSA3002 (NCT03158285) studies. Data after meeting 1 or more TF criteria were imputed as no change from baseline. Missing data were assumed missing at random and imputed using multiple imputation.

Enthesitis was assessed using the LEI, a tool developed to assess enthesitis in participants with PsA and evaluates the presence (score of 1) or absence (score of 0) of pain by applying local pressure to the following entheses: left and right lateral epicondyle humerus, left and right medial femoral condyle, and left and right achilles tendon insertion. The enthesitis index score is a total score of the 6 evaluated sites from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). Negative changes from baseline indicate improvement of enthesitis. The outcome measure was planned to be reported for pooled population from CNTO1959PSA3001 and CNTO1959PSA3002 studies.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=255 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=230 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=243 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in Enthesitis Score (Based on LEI) at Week 24 Among the Participants With Enthesitis at Baseline	-1.02 units on a scale Interval -1.22 to -0.82	-1.52 units on a scale Interval -1.73 to -1.31	-1.59 units on a scale Interval -1.79 to -1.38

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Analysis population is FAS1 among participants with dactylitis at baseline pooled from both from CNTO1959PSA3001 (NCT03162796) and CNTO1959PSA3002 (NCT03158285) studies. Data after meeting 1 or more TF criteria were imputed as no change from baseline. Missing data were assumed missing at random and imputed using multiple imputation.

The presence and severity of dactylitis was assessed in both hands and feet using a scoring system from 0 to 3 (0-no dactylitis, 1-mild dactylitis, 2-moderate dactylitis, and 3-severe dactylitis) for each digit. The results were summed to produce a final score ranging from 0 to 60. Higher score indicates more severe dactylitis. Negative changes from baseline indicate improvement of dactylitis. The outcome measure was planned to be reported for pooled population from CNTO1959PSA3001 and CNTO1959PSA3002 studies.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=154 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=160 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=159 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in Dactylitis Scores at Week 24 Among the Participants With Dactylitis at Baseline	-4.21 units on a scale Interval -5.05 to -3.36	-6.10 units on a scale Interval -6.92 to -5.27	-5.97 units on a scale Interval -6.84 to -5.11

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Analysis population is FAS1. Data after meeting one or more TF criteria were imputed as no change from baseline. Missing data were assumed to be missing at random (MAR) and imputed using multiple imputation (MI).

SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The PCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=246 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=248 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=245 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24	3.42 units on a scale Interval 2.53 to 4.32	7.39 units on a scale Interval 6.5 to 8.29	7.04 units on a scale Interval 6.14 to 7.94

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Analysis population is FAS1. Data after meeting one or more TF criteria were imputed as no change from baseline. Missing data were assumed to be missing at random (MAR) and imputed using multiple imputation (MI).

The Disease Activity Index Score (DAS28) based on C-Reactive Protein (CRP) is an index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. Negative changes from baseline indicate improvement of arthritis.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=246 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=248 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=245 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in Disease Activity Score (DAS28) (C-reactive Protein [CRP]) Score at Week 24	-0.97 units on a scale Interval -1.11 to -0.84	-1.59 units on a scale Interval -1.72 to -1.45	-1.62 units on a scale Interval -1.76 to -1.49

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Analysis population is FAS1. Data after meeting one or more TF criteria were imputed as no change from baseline. Missing data were assumed to be missing at random (MAR) and imputed using multiple imputation (MI).

SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The MCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=246 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=248 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=245 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in 36-Item Short Form Health Survey (SF-36) Mental Component Summary (MCS) at Week 24	2.14 units on a scale Interval 1.07 to 3.22	4.17 units on a scale Interval 3.1 to 5.23	4.22 units on a scale Interval 3.14 to 5.29

SECONDARY outcome

Timeframe: Week 16

Population: Analysis population is FAS1. Participants who achieved ACR 50 response at Week 16 and did not meet any TF criteria before Week 16 were considered as responders. Participants who met 1 or more TF criteria or with missing data were considered as non-responders.

ACR 50 response was defined as >= 50% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=50% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=246 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=248 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=245 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 50 Response at Week 16	9.3 percentage of participants	28.6 percentage of participants	20.8 percentage of participants

SECONDARY outcome

Timeframe: Week 24

Population: Analysis population is FAS1. Participants who achieved ACR 70 response at Week 24 and did not meet any TF criteria before Week 24 were considered as responders. Participants who met 1 or more TF criteria or with missing data were considered as non-responders.

ACR 70 response was defined as >= 70% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=70% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=246 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=248 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=245 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 70 Response at Week 24	4.1 percentage of participants	18.5 percentage of participants	13.1 percentage of participants

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12, 16, 20 and 24

Population: Analysis population is FAS1. Participants who achieved ACR 20 response at a specific time point and did not meet any TF criteria before, were considered as responders at that time point. Participants who met 1 or more TF criteria before or with missing data at that time point were considered as non-responders.

ACR 20 response was defined as >= 20% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=20% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=246 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=248 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=245 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved ACR 20 Response Through Week 24 Week 24	32.9 percentage of participants	64.1 percentage of participants	63.7 percentage of participants
Percentage of Participants Who Achieved ACR 20 Response Through Week 24 Week 2	8.1 percentage of participants	10.1 percentage of participants	10.6 percentage of participants
Percentage of Participants Who Achieved ACR 20 Response Through Week 24 Week 4	11.8 percentage of participants	19.8 percentage of participants	21.6 percentage of participants
Percentage of Participants Who Achieved ACR 20 Response Through Week 24 Week 8	17.5 percentage of participants	39.1 percentage of participants	40.0 percentage of participants
Percentage of Participants Who Achieved ACR 20 Response Through Week 24 Week 12	26.4 percentage of participants	49.6 percentage of participants	51.0 percentage of participants
Percentage of Participants Who Achieved ACR 20 Response Through Week 24 Week 16	33.7 percentage of participants	55.2 percentage of participants	55.9 percentage of participants
Percentage of Participants Who Achieved ACR 20 Response Through Week 24 Week 20	29.7 percentage of participants	62.9 percentage of participants	58.8 percentage of participants

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12, 16, 20 and 24

Population: Analysis population is FAS1. Participants who achieved ACR 50 response at a specific time point and did not meet any TF criteria before, were considered as responders at that time point. Participants who met 1 or more TF criteria before or with missing data at that time point were considered as non-responders.

ACR 50 response was defined as >= 50% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=50% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=246 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=248 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=245 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved ACR 50 Response Through Week 24 Week 12	6.1 percentage of participants	19.0 percentage of participants	16.7 percentage of participants
Percentage of Participants Who Achieved ACR 50 Response Through Week 24 Week 2	0.4 percentage of participants	1.6 percentage of participants	0.4 percentage of participants
Percentage of Participants Who Achieved ACR 50 Response Through Week 24 Week 4	1.2 percentage of participants	4.0 percentage of participants	3.3 percentage of participants
Percentage of Participants Who Achieved ACR 50 Response Through Week 24 Week 8	4.1 percentage of participants	10.1 percentage of participants	11.0 percentage of participants
Percentage of Participants Who Achieved ACR 50 Response Through Week 24 Week 16	9.3 percentage of participants	28.6 percentage of participants	20.8 percentage of participants
Percentage of Participants Who Achieved ACR 50 Response Through Week 24 Week 20	16.3 percentage of participants	31.5 percentage of participants	29.8 percentage of participants
Percentage of Participants Who Achieved ACR 50 Response Through Week 24 Week 24	14.2 percentage of participants	31.5 percentage of participants	33.1 percentage of participants

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12, 16, 20 and 24

Population: Analysis population is FAS1. Participants who achieved ACR 70 response at a specific time point and did not meet any TF criteria before, were considered as responders at that time point. Participants who met 1 or more TF criteria before or with missing data at that time point were considered as non-responders.

ACR 70 response was defined as >= 70% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=70% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=246 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=248 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=245 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved ACR 70 Response Through Week 24 Week 8	0.8 percentage of participants	3.6 percentage of participants	2.0 percentage of participants
Percentage of Participants Who Achieved ACR 70 Response Through Week 24 Week 12	0.4 percentage of participants	8.1 percentage of participants	4.9 percentage of participants
Percentage of Participants Who Achieved ACR 70 Response Through Week 24 Week 2	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants Who Achieved ACR 70 Response Through Week 24 Week 4	0.8 percentage of participants	0.4 percentage of participants	0.8 percentage of participants
Percentage of Participants Who Achieved ACR 70 Response Through Week 24 Week 16	0.8 percentage of participants	13.7 percentage of participants	8.2 percentage of participants
Percentage of Participants Who Achieved ACR 70 Response Through Week 24 Week 20	3.3 percentage of participants	15.3 percentage of participants	13.9 percentage of participants
Percentage of Participants Who Achieved ACR 70 Response Through Week 24 Week 24	4.1 percentage of participants	18.5 percentage of participants	13.1 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24

Population: Analysis population is FAS1. Here 'n' (number analyzed) signifies number of participants with observed data regardless meeting TF criteria at specified categories.

ACR components include swollen joint count (66 joints), tender joint count (68 joints), patient's assessment of pain using visual analog scale (VAS; 0-10 cm, 0=no pain and 10=worst possible pain), patient's global assessment (PtGA) of disease activity (arthritis, VAS; 0-10 cm, 0=excellent and 10= poor), physician's global assessment (PGA) of disease activity (VAS; 0-10 cm, 0=no arthritis activity and 10=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP (milligram/deciliter [mg/dL]).

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=246 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=248 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=245 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 12: PtGA of Disease Activity	-9.30 percent change Standard Deviation 37.185	-27.86 percent change Standard Deviation 38.900	-28.33 percent change Standard Deviation 34.058
Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 20: PtGA of Disease Activity	-12.52 percent change Standard Deviation 42.498	-35.31 percent change Standard Deviation 36.205	-35.11 percent change Standard Deviation 37.791
Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 16: PGA of Disease Activity	-31.11 percent change Standard Deviation 32.023	-52.02 percent change Standard Deviation 31.915	-49.18 percent change Standard Deviation 31.383
Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 20: PGA of Disease Activity	-34.13 percent change Standard Deviation 36.576	-54.32 percent change Standard Deviation 30.941	-54.59 percent change Standard Deviation 29.336
Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 2: CRP	86.677 percent change Standard Deviation 645.0281	0.935 percent change Standard Deviation 91.3783	10.664 percent change Standard Deviation 132.5947
Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 4: CRP	28.042 percent change Standard Deviation 208.6385	-16.885 percent change Standard Deviation 79.3501	1.128 percent change Standard Deviation 168.9301
Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 8: CRP	45.451 percent change Standard Deviation 322.4433	-11.214 percent change Standard Deviation 150.1689	-17.474 percent change Standard Deviation 112.3803
Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 12: CRP	47.034 percent change Standard Deviation 313.9875	-25.620 percent change Standard Deviation 97.1384	-22.277 percent change Standard Deviation 122.3489
Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 20: CRP	42.282 percent change Standard Deviation 284.1330	-13.551 percent change Standard Deviation 193.3814	-28.701 percent change Standard Deviation 83.0912
Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 24: CRP	19.263 percent change Standard Deviation 149.5120	-27.470 percent change Standard Deviation 109.5239	-28.125 percent change Standard Deviation 87.7229
Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 8: Tender Joint Count	-21.9 percent change Standard Deviation 37.83	-31.0 percent change Standard Deviation 42.36	-33.8 percent change Standard Deviation 37.58
Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 12: Swollen Joint Count	-46.1 percent change Standard Deviation 41.20	-57.6 percent change Standard Deviation 39.22	-58.3 percent change Standard Deviation 35.42
Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 16: Swollen Joint Count	-48.6 percent change Standard Deviation 43.01	-64.1 percent change Standard Deviation 35.46	-63.7 percent change Standard Deviation 34.42
Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 20: Swollen Joint Count	-54.2 percent change Standard Deviation 41.70	-69.3 percent change Standard Deviation 33.63	-71.4 percent change Standard Deviation 30.42
Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 24: Swollen Joint Count	-53.9 percent change Standard Deviation 45.54	-71.3 percent change Standard Deviation 34.06	-73.1 percent change Standard Deviation 30.67
Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 2: Tender Joint Count	-9.4 percent change Standard Deviation 25.99	-10.4 percent change Standard Deviation 40.31	-14.8 percent change Standard Deviation 28.31
Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 4: Tender Joint Count	-14.1 percent change Standard Deviation 36.04	-15.0 percent change Standard Deviation 41.57	-22.6 percent change Standard Deviation 32.91
Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 12: Tender Joint Count	-30.4 percent change Standard Deviation 37.57	-40.9 percent change Standard Deviation 42.73	-43.0 percent change Standard Deviation 35.90
Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 16: Tender Joint Count	-30.6 percent change Standard Deviation 41.87	-47.0 percent change Standard Deviation 40.96	-48.1 percent change Standard Deviation 37.01
Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 2: Swollen Joint Count	-18.9 percent change Standard Deviation 32.16	-18.8 percent change Standard Deviation 39.68	-18.5 percent change Standard Deviation 38.38
Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 4: Swollen Joint Count	-27.1 percent change Standard Deviation 37.29	-30.5 percent change Standard Deviation 36.92	-33.6 percent change Standard Deviation 37.57
Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 8: Swollen Joint Count	-37.4 percent change Standard Deviation 39.03	-46.8 percent change Standard Deviation 40.68	-46.7 percent change Standard Deviation 37.69
Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 2: Patient's Assessment of Pain	0.05 percent change Standard Deviation 35.794	-8.92 percent change Standard Deviation 32.374	-4.66 percent change Standard Deviation 32.229
Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 4: Patient's Assessment of Pain	-0.64 percent change Standard Deviation 35.849	-12.58 percent change Standard Deviation 33.065	-7.96 percent change Standard Deviation 37.958
Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 20: Tender Joint Count	-33.9 percent change Standard Deviation 44.22	-53.9 percent change Standard Deviation 37.83	-54.2 percent change Standard Deviation 35.43
Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 24: Tender Joint Count	-33.3 percent change Standard Deviation 44.87	-54.2 percent change Standard Deviation 37.15	-57.3 percent change Standard Deviation 34.98
Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 8: Patient's Assessment of Pain	-6.76 percent change Standard Deviation 34.213	-21.61 percent change Standard Deviation 36.705	-17.05 percent change Standard Deviation 44.783
Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 12: Patient's Assessment of Pain	-9.01 percent change Standard Deviation 36.061	-26.26 percent change Standard Deviation 40.223	-25.91 percent change Standard Deviation 37.862
Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 2: PtGA of Disease Activity	-1.12 percent change Standard Deviation 35.882	-10.15 percent change Standard Deviation 31.060	-5.25 percent change Standard Deviation 32.658
Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 4: PtGA of Disease Activity	-2.27 percent change Standard Deviation 34.291	-12.71 percent change Standard Deviation 34.440	-11.02 percent change Standard Deviation 33.605
Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 8: PtGA of Disease Activity	-6.51 percent change Standard Deviation 35.908	-21.58 percent change Standard Deviation 33.697	-19.13 percent change Standard Deviation 40.545
Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 16: PtGA of Disease Activity	-12.34 percent change Standard Deviation 39.207	-32.25 percent change Standard Deviation 40.056	-28.60 percent change Standard Deviation 39.759
Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 24: PtGA of Disease Activity	-13.87 percent change Standard Deviation 45.650	-37.05 percent change Standard Deviation 38.372	-34.13 percent change Standard Deviation 51.445
Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 2: PGA of Disease Activity	-9.79 percent change Standard Deviation 25.687	-15.06 percent change Standard Deviation 27.150	-13.85 percent change Standard Deviation 23.307
Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 4: PGA of Disease Activity	-16.63 percent change Standard Deviation 27.573	-23.72 percent change Standard Deviation 27.658	-22.32 percent change Standard Deviation 28.183
Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 8: PGA of Disease Activity	-23.29 percent change Standard Deviation 28.416	-36.54 percent change Standard Deviation 31.224	-37.99 percent change Standard Deviation 29.970
Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 12: PGA of Disease Activity	-27.63 percent change Standard Deviation 32.379	-46.54 percent change Standard Deviation 30.489	-42.84 percent change Standard Deviation 31.305
Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 24: PGA of Disease Activity	-36.59 percent change Standard Deviation 33.740	-57.22 percent change Standard Deviation 32.480	-58.70 percent change Standard Deviation 28.255
Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 2: HAQ-DI Score	-0.3191 percent change Standard Deviation 36.62364	-6.3577 percent change Standard Deviation 50.81980	-0.2385 percent change Standard Deviation 57.44896
Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 4: HAQ-DI Score	-2.8744 percent change Standard Deviation 46.90795	-9.1272 percent change Standard Deviation 53.41051	-5.1209 percent change Standard Deviation 85.16625
Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 8: HAQ-DI Score	-5.0965 percent change Standard Deviation 39.89566	-12.7684 percent change Standard Deviation 67.23239	-9.8081 percent change Standard Deviation 86.78973
Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 12: HAQ-DI Score	-8.0811 percent change Standard Deviation 46.90093	-18.0336 percent change Standard Deviation 66.96524	-17.7758 percent change Standard Deviation 67.44643
Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 16: HAQ-DI Score	-7.1776 percent change Standard Deviation 48.33253	-19.3627 percent change Standard Deviation 70.83578	-26.6732 percent change Standard Deviation 53.14973
Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 20: HAQ-DI Score	-10.4296 percent change Standard Deviation 50.87958	-24.9496 percent change Standard Deviation 64.86820	-28.9317 percent change Standard Deviation 60.67279
Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 24: HAQ-DI Score	-6.7995 percent change Standard Deviation 54.78602	-25.2578 percent change Standard Deviation 63.15450	-33.8837 percent change Standard Deviation 51.59441
Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 16: CRP	28.595 percent change Standard Deviation 237.6660	-19.874 percent change Standard Deviation 134.5210	-26.592 percent change Standard Deviation 86.8465
Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 16: Patient's Assessment of Pain(0-10cm)	-9.70 percent change Standard Deviation 41.673	-31.94 percent change Standard Deviation 42.882	-27.85 percent change Standard Deviation 38.913
Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 20: Patient's Assessment of Pain	-10.85 percent change Standard Deviation 46.497	-35.16 percent change Standard Deviation 39.471	-35.35 percent change Standard Deviation 39.016
Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 24: Patient's Assessment of Pain	-11.84 percent change Standard Deviation 48.324	-38.06 percent change Standard Deviation 40.565	-36.52 percent change Standard Deviation 38.423

SECONDARY outcome

Timeframe: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24

Population: Analysis population is FAS1. Data after meeting one or more TF criteria were imputed as no change from baseline. Missing data were assumed to be missing at random (MAR) and imputed using multiple imputation (MI).

HAQ-DI score assess functional status of participant. It is a 20 question instrument that assess the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0=indicating no difficulty, to 3=indicating inability to perform a task in that area. Total HAQ score is average of the computed categories scores ranging from 0-3 where 0=least difficulty and 3=extreme difficulty. Lower scores are indicative of better functioning. Negative changes from baseline indicate improvement of physical function.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=246 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=248 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=245 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in HAQ-DI Score at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 2	-0.0594 units on a scale Interval -0.1023 to -0.0165	-0.1423 units on a scale Interval -0.185 to -0.0997	-0.0795 units on a scale Interval -0.1226 to -0.0364
Change From Baseline in HAQ-DI Score at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 20	-0.1565 units on a scale Interval -0.2163 to -0.0968	-0.3536 units on a scale Interval -0.4131 to -0.2941	-0.4019 units on a scale Interval -0.4618 to -0.342
Change From Baseline in HAQ-DI Score at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 4	-0.0722 units on a scale Interval -0.1196 to -0.0247	-0.1472 units on a scale Interval -0.1944 to -0.1	-0.1605 units on a scale Interval -0.2081 to -0.1128
Change From Baseline in HAQ-DI Score at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 8	-0.0942 units on a scale Interval -0.1464 to -0.042	-0.2294 units on a scale Interval -0.2815 to -0.1773	-0.2336 units on a scale Interval -0.2859 to -0.1813
Change From Baseline in HAQ-DI Score at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 12	-0.1332 units on a scale Interval -0.1875 to -0.079	-0.2870 units on a scale Interval -0.3411 to -0.233	-0.3010 units on a scale Interval -0.3554 to -0.2466
Change From Baseline in HAQ-DI Score at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 16	-0.1167 units on a scale Interval -0.1753 to -0.0582	-0.3177 units on a scale Interval -0.376 to -0.2595	-0.3442 units on a scale Interval -0.4029 to -0.2855
Change From Baseline in HAQ-DI Score at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 24	-0.1300 units on a scale Interval -0.1912 to -0.0687	-0.3672 units on a scale Interval -0.4282 to -0.3062	-0.4004 units on a scale Interval -0.4617 to -0.339

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12, 16, 20 and 24

Population: FAS1 among participants with HAQ-DI \>=0.35 at baseline. Participants with HAQ-DI \>=0.35 improvement from baseline at specific timepoint and did not meet any TF criteria before, were considered responders at that time point. Participants who met 1 or more TF criteria before or with missing data at that time point were considered non-responders.

HAQ-DI score assess functional status of participant. It is a 20 question instrument that assess the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0=indicating no difficulty, to 3=indicating inability to perform a task in that area. Total HAQ score is average of the computed categories scores ranging from 0-3, where 0=least difficulty and 3=extreme difficulty. Lower scores are indicative of better functioning and a decrease of 0.35 from baseline in HAQ-DI score indicates a meaningful improvement.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=236 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=228 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=228 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved >=0.35 Improvement From Baseline in HAQ-DI Score Through Week 24 Among Participants With HAQ-DI Score >=0.35 at Baseline Week 2	19.9 percentage of participants	30.7 percentage of participants	23.2 percentage of participants
Percentage of Participants Who Achieved >=0.35 Improvement From Baseline in HAQ-DI Score Through Week 24 Among Participants With HAQ-DI Score >=0.35 at Baseline Week 4	23.7 percentage of participants	32.0 percentage of participants	35.1 percentage of participants
Percentage of Participants Who Achieved >=0.35 Improvement From Baseline in HAQ-DI Score Through Week 24 Among Participants With HAQ-DI Score >=0.35 at Baseline Week 20	38.6 percentage of participants	48.7 percentage of participants	53.1 percentage of participants
Percentage of Participants Who Achieved >=0.35 Improvement From Baseline in HAQ-DI Score Through Week 24 Among Participants With HAQ-DI Score >=0.35 at Baseline Week 8	28.0 percentage of participants	43.4 percentage of participants	42.5 percentage of participants
Percentage of Participants Who Achieved >=0.35 Improvement From Baseline in HAQ-DI Score Through Week 24 Among Participants With HAQ-DI Score >=0.35 at Baseline Week 12	31.8 percentage of participants	47.4 percentage of participants	46.9 percentage of participants
Percentage of Participants Who Achieved >=0.35 Improvement From Baseline in HAQ-DI Score Through Week 24 Among Participants With HAQ-DI Score >=0.35 at Baseline Week 16	30.9 percentage of participants	50.0 percentage of participants	51.8 percentage of participants
Percentage of Participants Who Achieved >=0.35 Improvement From Baseline in HAQ-DI Score Through Week 24 Among Participants With HAQ-DI Score >=0.35 at Baseline Week 24	31.4 percentage of participants	50.0 percentage of participants	56.1 percentage of participants

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12, 16, 20 and 24

Population: Analysis population is FAS1. Participants who achieved a DAS28 (CRP) response at a specific time point and did not meet any TF criteria before, were considered as responders at that time point. Participants who met 1 or more TF criteria before or with missing data at that time point were considered as non-responders.

DAS28 based on CRP is an index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. DAS 28 (CRP) response criteria was defined as follows: Good response: <=3.2 at visit and >1.2 improvement; Moderate response: >3.2 at visit and >1.2 improvement or <=5.1 at visit and >0.6-1.2 improvement; No response: <=0.6 improvement, or >5.1 at visit and <=1.2 improvement. The values are 0=best to 10=worst. A DAS28 (CRP) responder is defined as achieving a good or moderate DAS28 response at a specific visit.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=246 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=248 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=245 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved a DAS28 (CRP) Response Through Week 24 Week 12	51.2 percentage of participants	67.3 percentage of participants	65.7 percentage of participants
Percentage of Participants Who Achieved a DAS28 (CRP) Response Through Week 24 Week 20	50.4 percentage of participants	75.0 percentage of participants	76.3 percentage of participants
Percentage of Participants Who Achieved a DAS28 (CRP) Response Through Week 24 Week 2	21.5 percentage of participants	23.8 percentage of participants	24.5 percentage of participants
Percentage of Participants Who Achieved a DAS28 (CRP) Response Through Week 24 Week 4	32.9 percentage of participants	38.7 percentage of participants	40.8 percentage of participants
Percentage of Participants Who Achieved a DAS28 (CRP) Response Through Week 24 Week 8	38.6 percentage of participants	56.9 percentage of participants	54.7 percentage of participants
Percentage of Participants Who Achieved a DAS28 (CRP) Response Through Week 24 Week 16	51.2 percentage of participants	69.8 percentage of participants	72.7 percentage of participants
Percentage of Participants Who Achieved a DAS28 (CRP) Response Through Week 24 Week 24	52.4 percentage of participants	75.4 percentage of participants	80.0 percentage of participants

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12, 16, 20 and 24

Population: Analysis population is FAS1. Participants who achieved a DAS28 (CRP) remission at a specific time point and did not meet any TF criteria before, were considered as responders at that time point. Participants who met 1 or more TF criteria before or with missing data at that time point were considered as non-responders.

DAS28 based on CRP is an index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. DAS 28 (CRP) remission was defined as DAS 28 (CRP) value <2.6 at the analysis visit.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=246 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=248 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=245 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved a DAS28 (CRP) Remission Through Week 24 Week 12	6.1 percentage of participants	14.1 percentage of participants	11.8 percentage of participants
Percentage of Participants Who Achieved a DAS28 (CRP) Remission Through Week 24 Week 16	6.5 percentage of participants	18.5 percentage of participants	16.3 percentage of participants
Percentage of Participants Who Achieved a DAS28 (CRP) Remission Through Week 24 Week 20	9.8 percentage of participants	23.0 percentage of participants	21.2 percentage of participants
Percentage of Participants Who Achieved a DAS28 (CRP) Remission Through Week 24 Week 2	0.8 percentage of participants	2.4 percentage of participants	2.4 percentage of participants
Percentage of Participants Who Achieved a DAS28 (CRP) Remission Through Week 24 Week 4	2.0 percentage of participants	5.2 percentage of participants	4.9 percentage of participants
Percentage of Participants Who Achieved a DAS28 (CRP) Remission Through Week 24 Week 8	0.8 percentage of participants	10.5 percentage of participants	9.0 percentage of participants
Percentage of Participants Who Achieved a DAS28 (CRP) Remission Through Week 24 Week 24	8.5 percentage of participants	24.6 percentage of participants	23.3 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24

Population: Analysis population is FAS1. Data after meeting one or more TF criteria were imputed as no change from baseline. Missing data were assumed to be missing at random (MAR) and imputed using multiple imputation (MI).

DAS28 based on CRP is an index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. Negative changes from baseline indicate improvement of arthritis.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=246 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=248 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=245 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 2	-0.29 units on a scale Interval -0.37 to -0.21	-0.42 units on a scale Interval -0.5 to -0.33	-0.43 units on a scale Interval -0.51 to -0.35
Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 4	-0.44 units on a scale Interval -0.53 to -0.35	-0.62 units on a scale Interval -0.71 to -0.53	-0.65 units on a scale Interval -0.74 to -0.55
Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 24	-0.97 units on a scale Interval -1.11 to -0.84	-1.59 units on a scale Interval -1.72 to -1.45	-1.62 units on a scale Interval -1.76 to -1.49
Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 8	-0.59 units on a scale Interval -0.71 to -0.48	-0.99 units on a scale Interval -1.11 to -0.88	-0.98 units on a scale Interval -1.09 to -0.86
Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 12	-0.85 units on a scale Interval -0.97 to -0.73	-1.27 units on a scale Interval -1.39 to -1.15	-1.22 units on a scale Interval -1.35 to -1.1
Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 16	-0.88 units on a scale Interval -1.01 to -0.75	-1.39 units on a scale Interval -1.52 to -1.26	-1.37 units on a scale Interval -1.5 to -1.24
Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 20	-1.00 units on a scale Interval -1.13 to -0.87	-1.52 units on a scale Interval -1.65 to -1.38	-1.56 units on a scale Interval -1.7 to -1.43

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12, 16, 20 and 24

Population: Analysis population is FAS1. Participants who achieved a modified PsARC response at a specific time point and did not meet any TF criteria before, were considered as responders at that time point. Participants who met 1 or more TF criteria before or with missing data at that time point were considered as non-responders.

The modified PsARC response was defined as improvement in at least 2 of the four criteria: >=30% decrease in swollen joint count, >=30% decrease in tender joint count, >=20% improvement in patient's Global Assessment of Disease Activity (arthritis) on a VAS (0-100 mm, 0=excellent and 100= poor), >=20% improvement in physician's Global Assessment of Disease Activity using VAS (VAS: 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), and at least one of the 2 joint criteria with no deterioration in the other criteria.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=246 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=248 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=245 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) Through Week 24 Week 4	27.2 percentage of participants	32.7 percentage of participants	29.8 percentage of participants
Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) Through Week 24 Week 8	35.8 percentage of participants	48.8 percentage of participants	50.2 percentage of participants
Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) Through Week 24 Week 12	40.7 percentage of participants	60.9 percentage of participants	60.8 percentage of participants
Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) Through Week 24 Week 2	13.0 percentage of participants	22.2 percentage of participants	18.0 percentage of participants
Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) Through Week 24 Week 16	44.7 percentage of participants	66.5 percentage of participants	66.5 percentage of participants
Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) Through Week 24 Week 20	46.7 percentage of participants	72.2 percentage of participants	69.0 percentage of participants
Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) Through Week 24 Week 24	44.7 percentage of participants	72.6 percentage of participants	68.6 percentage of participants

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 16 and 24

Population: FAS1 among participants with enthesitis at baseline. Participants with enthesitis resolution at specific time point and did not meet any TF criteria before, were considered as responders at that time point. Participants who met 1 or more TF criteria before or with missing data at that time point were considered as non-responders.

Enthesitis was assessed using the LEI, a tool developed to assess enthesitis in participants with PsA and evaluates the presence (score of 1) or absence (score of 0) of pain by applying local pressure to the following entheses: left and right lateral epicondyle humerus, left and right medial femoral condyle, and left and right achilles tendon insertion. The enthesitis index score is a total score of the 6 evaluated sites from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). A LEI score of 0 at a post baseline visit indicates resolution of enthesitis when baseline LEI>0.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=178 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=158 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=170 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants With Resolution of Enthesitis Through Week 24 Among the Participants With Enthesitis at Baseline Week 2	16.3 percentage of participants	17.7 percentage of participants	17.1 percentage of participants
Percentage of Participants With Resolution of Enthesitis Through Week 24 Among the Participants With Enthesitis at Baseline Week 4	18.0 percentage of participants	21.5 percentage of participants	25.3 percentage of participants
Percentage of Participants With Resolution of Enthesitis Through Week 24 Among the Participants With Enthesitis at Baseline Week 8	24.7 percentage of participants	31.0 percentage of participants	27.6 percentage of participants
Percentage of Participants With Resolution of Enthesitis Through Week 24 Among the Participants With Enthesitis at Baseline Week 16	30.9 percentage of participants	47.5 percentage of participants	40.6 percentage of participants
Percentage of Participants With Resolution of Enthesitis Through Week 24 Among the Participants With Enthesitis at Baseline Week 24	30.3 percentage of participants	53.8 percentage of participants	43.5 percentage of participants

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 16 and 24

Population: FAS1 among participants with dactylitis at baseline. Participants who achieved dactylitis resolution at specific time point and did not meet any TF criteria before, were considered as responders at that time point. Participants who met 1 or more TF criteria before or with missing data at that time point were considered as non-responders.

The presence and severity of dactylitis was assessed in both hands and feet using a scoring system from 0 to 3 (0-no dactylitis, 1-mild dactylitis, 2-moderate dactylitis, and 3-severe dactylitis) for each digit. The results were summed to produce a final score ranging from 0 to 60. Higher score indicates more severe dactylitis. Resolution of dactylitis was defined as a dactylitis score of 0 with the baseline dactylitis score >0.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=99 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=111 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=121 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants With Resolution of Dactylitis Through Week 24 Among the Participants With Dactylitis at Baseline Week 2	12.1 percentage of participants	13.5 percentage of participants	13.2 percentage of participants
Percentage of Participants With Resolution of Dactylitis Through Week 24 Among the Participants With Dactylitis at Baseline Week 16	36.4 percentage of participants	45.0 percentage of participants	52.1 percentage of participants
Percentage of Participants With Resolution of Dactylitis Through Week 24 Among the Participants With Dactylitis at Baseline Week 24	38.4 percentage of participants	56.8 percentage of participants	63.6 percentage of participants
Percentage of Participants With Resolution of Dactylitis Through Week 24 Among the Participants With Dactylitis at Baseline Week 4	18.2 percentage of participants	19.8 percentage of participants	20.7 percentage of participants
Percentage of Participants With Resolution of Dactylitis Through Week 24 Among the Participants With Dactylitis at Baseline Week 8	29.3 percentage of participants	30.6 percentage of participants	31.4 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 16 and 24

Population: Analysis population is FAS1 among participants with enthesitis at baseline. Data after meeting 1 or more TF criteria were imputed as no change from baseline. Missing data were assumed missing at random and imputed using multiple imputation.

Enthesitis was assessed using the LEI, a tool developed to assess enthesitis in participants with PsA and evaluates the presence (score of 1) or absence (score of 0) of pain by applying local pressure to the following entheses: left and right lateral epicondyle humerus, left and right medial femoral condyle, and left and right achilles tendon insertion. The enthesitis index score is a total score of the 6 evaluated sites from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). Negative changes from baseline indicate improvement of enthesitis.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=178 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=158 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=170 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 2, 4, 8, 16, and 24 Among the Participants With Enthesitis at Baseline Week 24	-1.03 units on a scale Interval -1.25 to -0.81	-1.60 units on a scale Interval -1.84 to -1.37	-1.52 units on a scale Interval -1.75 to -1.29
Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 2, 4, 8, 16, and 24 Among the Participants With Enthesitis at Baseline Week 2	-0.33 units on a scale Interval -0.53 to -0.12	-0.37 units on a scale Interval -0.59 to -0.16	-0.49 units on a scale Interval -0.7 to -0.29
Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 2, 4, 8, 16, and 24 Among the Participants With Enthesitis at Baseline Week 4	-0.46 units on a scale Interval -0.68 to -0.24	-0.56 units on a scale Interval -0.79 to -0.33	-0.69 units on a scale Interval -0.92 to -0.47
Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 2, 4, 8, 16, and 24 Among the Participants With Enthesitis at Baseline Week 8	-0.67 units on a scale Interval -0.9 to -0.45	-0.92 units on a scale Interval -1.16 to -0.67	-0.88 units on a scale Interval -1.11 to -0.64
Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 2, 4, 8, 16, and 24 Among the Participants With Enthesitis at Baseline Week 16	-0.94 units on a scale Interval -1.18 to -0.71	-1.37 units on a scale Interval -1.62 to -1.12	-1.42 units on a scale Interval -1.66 to -1.18

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 16 and 24

Population: Analysis population is FAS1 among participants with dactylitis at baseline. Data after meeting 1 or more TF criteria were imputed as no change from baseline. Missing data were assumed missing at random and imputed using multiple imputation.

The presence and severity of dactylitis was assessed in both hands and feet using a scoring system from 0 to 3 (0-no dactylitis, 1-mild dactylitis, 2-moderate dactylitis, and 3-severe dactylitis) for each digit. The results were summed to produce a final score ranging from 0 to 60. Higher score indicates more severe dactylitis. Negative changes from baseline indicate improvement of dactylitis.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=99 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=111 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=121 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in Dactylitis Scores at Weeks 2, 4, 8, 16 and 24 Among the Participants With Dactylitis at Baseline Week 2	-0.21 units on a scale Interval -1.11 to 0.69	-1.11 units on a scale Interval -1.95 to -0.26	-0.78 units on a scale Interval -1.61 to 0.05
Change From Baseline in Dactylitis Scores at Weeks 2, 4, 8, 16 and 24 Among the Participants With Dactylitis at Baseline Week 4	-1.10 units on a scale Interval -2.07 to -0.13	-2.11 units on a scale Interval -3.02 to -1.2	-1.56 units on a scale Interval -2.47 to -0.66
Change From Baseline in Dactylitis Scores at Weeks 2, 4, 8, 16 and 24 Among the Participants With Dactylitis at Baseline Week 8	-2.17 units on a scale Interval -3.19 to -1.16	-3.17 units on a scale Interval -4.12 to -2.22	-3.11 units on a scale Interval -4.05 to -2.17
Change From Baseline in Dactylitis Scores at Weeks 2, 4, 8, 16 and 24 Among the Participants With Dactylitis at Baseline Week 16	-3.40 units on a scale Interval -4.42 to -2.38	-4.88 units on a scale Interval -5.84 to -3.92	-4.80 units on a scale Interval -5.75 to -3.85
Change From Baseline in Dactylitis Scores at Weeks 2, 4, 8, 16 and 24 Among the Participants With Dactylitis at Baseline Week 24	-4.03 units on a scale Interval -4.96 to -3.1	-5.95 units on a scale Interval -6.83 to -5.08	-5.88 units on a scale Interval -6.74 to -5.01

SECONDARY outcome

Timeframe: Baseline, Weeks 8, 16 and 24

Population: Analysis population is FAS1. Data after meeting 1 or more TF criteria were imputed as no change from baseline. Missing data were assumed missing at random. The LS mean is based on Mixed-effect repeated measures (MMRM) model that included data from all visits for all participants included in the model.

PASDAS (score range of 0 to 10, where higher score indicated more severe disease) is a composite score of overall disease activity combining Patient's Global Assessment of Disease Activity (arthritis and psoriasis, using VAS [0-100 mm, 0=excellent and 100= poor), Physician's Global Assessment of Disease Activity (using VAS [0-100 mm, 0=no arthritis activity and 100=extremely active arthritis]), swollen joint count (0-66 joints), tender joint count (0-68 joints), CRP (mg/L), enthesitis based on LEI (0= 0 sites with tenderness to 6= worst possible score; 6 sites with tenderness), tender dactylitis count (scoring each digit from 0-3 [where 0= no tenderness and 3= extreme tenderness] and recoding to 0-1, where any score > 0 equaled 1), and the PCS score with score range 0-100 (higher score-better quality of life) of the SF-36 health survey. The cutoffs for disease activity were 3.2 (low) to 5.4 (high). Negative changes from baseline indicate improvement of overall disease activity.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=246 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=248 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=245 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 8, 16 and 24 Week 8	-0.863 units on a scale Interval -1.007 to -0.719	-1.452 units on a scale Interval -1.595 to -1.309	-1.413 units on a scale Interval -1.557 to -1.27
Change From Baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 8, 16 and 24 Week 16	-1.158 units on a scale Interval -1.327 to -0.988	-2.110 units on a scale Interval -2.278 to -1.942	-1.994 units on a scale Interval -2.164 to -1.825
Change From Baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 8, 16 and 24 Week 24	-1.336 units on a scale Interval -1.516 to -1.156	-2.403 units on a scale Interval -2.582 to -2.225	-2.399 units on a scale Interval -2.579 to -2.219

SECONDARY outcome

Timeframe: Baseline, Weeks 16 and 24

Population: Analysis population is FAS1. Data after meeting 1 or more TF criteria were imputed as no change from baseline. Missing data were assumed missing at random. The LS mean is based on MMRM model that included data from all visits for all participants included in the model.

GRACE index is a composite PsA disease activity score converted from Arithmetic Mean of Desirability Function (AMDF), derived from TJC (0-68) and SJC (0-66), HAQ-DI (0-3), patient's global assessment of disease activity on arthritis and psoriasis (0-100 mm, 0=excellent and 100=poor), patient's assessment of skin disease activity (0-100 mm, 0=excellent and 100=poor), patient's global assessment of disease activity on arthritis (0-100 mm, 0=excellent and 100=poor), PASI (0-72), and PsA Quality of Life Index (derived as PsAQOL=25.355 + [2.367*HAQ-DI]-[0.234*SF-PCS]-[0.244*SF-MCS]), where HAQ-DI: HAQ-DI score (0-3, 0=least difficulty and 3=extreme difficulty), SF-PCS (Score ranges from 0-100, higher scores= better quality of life) and SF-MCS (score ranges from 0-100, higher scores= better quality of life). Total score is from 0-10, lower score=better response. Higher score indicates more active disease activity. Negative change from baseline indicates improvement of PsA disease activity.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=246 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=248 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=245 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) Composite Score (GRACE) at Weeks 16 and 24 Week 16	-1.029 units on a scale Interval -1.212 to -0.847	-2.326 units on a scale Interval -2.507 to -2.145	-2.214 units on a scale Interval -2.397 to -2.032
Change From Baseline in Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) Composite Score (GRACE) at Weeks 16 and 24 Week 24	-1.198 units on a scale Interval -1.395 to -1.001	-2.593 units on a scale Interval -2.789 to -2.397	-2.589 units on a scale Interval -2.786 to -2.392

SECONDARY outcome

Timeframe: Baseline, Weeks 16 and 24

Population: Analysis population is FAS1. Data after meeting 1/more TF criteria imputed as no change from baseline. Missing data assumed MAR. LS mean is based on MMRM model that included data from all visits for all participants included in model. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Work Productivity and Activity Impairment was assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) of PsA (WPAI-PsA). The WPAI-PsA consisted of 6 questions to determine employment status, hours missed from work due to PsA, hours missed from work for other reasons, hours actually worked, the degree to which PsA affected work productivity while at work and the degree to which PsA affected activities outside of work during the past 7 days. WPAI outcomes included percent work time missed due to PsA, percent impairment while working due to PsA, percent overall work impairment due to PsA, and percent activity impairment outside of work due to PsA. These WPAI outcomes were expressed as impairment percentages (0-100, 0=no impairment and 100=100% impaired), with higher numbers indicating greater impairment and less productivity. Negative changes from baseline indicate improvement of work productivity and activity impairment.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=155 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=145 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=145 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Work Time Missed) at Weeks 16 and 24 Week 16	-4.553 percentage of work time missed Interval -7.199 to -1.906	-3.451 percentage of work time missed Interval -6.199 to -0.703	-4.717 percentage of work time missed Interval -7.449 to -1.985
Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Work Time Missed) at Weeks 16 and 24 Week 24	-3.491 percentage of work time missed Interval -6.403 to -0.578	-3.103 percentage of work time missed Interval -6.062 to -0.144	-3.827 percentage of work time missed Interval -6.826 to -0.828

SECONDARY outcome

Timeframe: Baseline, Weeks 16 and 24

Population: Analysis population is FAS1. Data after meeting 1/more TF criteria imputed as no change from baseline. Missing data assumed MAR. LS mean is based on MMRM model that included data from all visits for all participants included in model. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Work Productivity and Activity Impairment was assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) of PsA (WPAI-PsA). The WPAI-PsA consisted of 6 questions to determine employment status, hours missed from work due to PsA, hours missed from work for other reasons, hours actually worked, the degree to which PsA affected work productivity while at work and the degree to which PsA affected activities outside of work during the past 7 days. WPAI outcomes included percent work time missed due to PsA, percent impairment while working due to PsA, percent overall work impairment due to PsA, and percent activity impairment outside of work due to PsA. These WPAI outcomes were expressed as impairment percentages (0-100, 0=no impairment and 100=100% impaired), with higher numbers indicating greater impairment and less productivity. Negative changes from baseline indicate improvement of work productivity and activity impairment.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=131 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=129 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=133 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Impairment While Working) at Weeks 16 and 24 Week 16	-10.281 percentage of impairment Interval -13.887 to -6.675	-16.054 percentage of impairment Interval -19.699 to -12.409	-15.083 percentage of impairment Interval -18.655 to -11.511
Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Impairment While Working) at Weeks 16 and 24 Week 24	-10.157 percentage of impairment Interval -13.663 to -6.65	-19.366 percentage of impairment Interval -22.857 to -15.875	-19.492 percentage of impairment Interval -22.982 to -16.003

SECONDARY outcome

Timeframe: Baseline, Weeks 16 and 24

Population: Analysis population is FAS1. Data after meeting 1/more TF criteria imputed as no change from baseline. Missing data assumed MAR. LS mean is based on MMRM model that included data from all visits for all participants included in model. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Work Productivity and Activity Impairment was assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) of PsA (WPAi-PsA). The WPAI-PsA consisted of 6 questions to determine employment status, hours missed from work due to PsA, hours missed from work for other reasons, hours actually worked, the degree to which PsA affected work productivity while at work and the degree to which PsA affected activities outside of work during the past 7 days. WPAI outcomes included percent work time missed due to PsA, percent impairment while working due to PsA, percent overall work impairment due to PsA, and percent activity impairment outside of work due to PsA. These WPAI outcomes were expressed as impairment percentages (0-100, 0=no impairment and 100=100% impaired), with higher numbers indicating greater impairment and less productivity. Negative changes from baseline indicate improvement of work productivity and activity impairment.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=131 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=129 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=133 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Overall Work Impairment) at Weeks 16 and 24 Week 16	-11.232 percentage of overall work impairment Interval -14.962 to -7.501	-15.926 percentage of overall work impairment Interval -19.694 to 12.159	-15.808 percentage of overall work impairment Interval -19.501 to -12.115
Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Overall Work Impairment) at Weeks 16 and 24 Week 24	-10.869 percentage of overall work impairment Interval -14.591 to -7.147	-19.711 percentage of overall work impairment Interval -23.416 to -16.006	-20.023 percentage of overall work impairment Interval -23.726 to -16.32

SECONDARY outcome

Timeframe: Baseline, Weeks 16 and 24

Population: Analysis population is FAS1. Data after meeting 1/more TF criteria imputed as no change from baseline. Missing data assumed MAR. LS mean is based on MMRM model that included data from all visits for all participants included in model. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Work Productivity and Activity Impairment was assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) of PsA (WPAI-PsA). The WPAI-PsA consisted of 6 questions to determine employment status, hours missed from work due to PsA, hours missed from work for other reasons, hours actually worked, the degree to which PsA affected work productivity while at work and the degree to which PsA affected activities outside of work during the past 7 days. WPAI outcomes included percent work time missed due to PsA, percent impairment while working due to PsA, percent overall work impairment due to PsA, and percent activity impairment outside of work due to PsA. These WPAI outcomes were expressed as impairment percentages (0-100, 0=no impairment and 100=100% impaired), with higher numbers indicating greater impairment and less productivity. Negative changes from baseline indicate improvement of work productivity and activity impairment.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=244 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=247 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=245 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Activity Impairment Outside of Work ) at Weeks 16 and 24 Week 24	-10.320 percentage of activity impairment Interval -13.071 to -7.57	-21.467 percentage of activity impairment Interval -24.204 to -18.729	-20.480 percentage of activity impairment Interval -23.226 to -17.734
Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Activity Impairment Outside of Work ) at Weeks 16 and 24 Week 16	-10.569 percentage of activity impairment Interval -13.262 to -7.877	-17.107 percentage of activity impairment Interval -19.787 to -14.428	-17.029 percentage of activity impairment Interval -19.727 to -14.331

SECONDARY outcome

Timeframe: Baseline, Weeks 16 and 24

Population: Analysis population is FAS1. Data after meeting 1 or more TF criteria were imputed as no change from baseline. Missing data were assumed missing at random. The LS mean is based on MMRM model that included data from all visits for all participants included in the model.

The mCPDAI assessed 4 domains (joints, skin, entheses, and dactylitis). The mCPDAI scores were calculated using the following assessments: joints (66 swollen and 68 tender joint counts), HAQ-DI score, PASI, dactylitis, and enthesitis. Within each domain a score (range 0-3) was assigned, where 0= Not involved, 1= Mild, 2= Moderate and 3= Severe. The scores for each domain were then added together to give a final score range of 0 to 12. A higher score indicates more active disease activity. Negative changes from baseline indicate improvement of PsA disease activity.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=246 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=248 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=245 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Week 16 and 24 Week 16	-1.18 units on a scale Interval -1.43 to -0.93	-2.39 units on a scale Interval -2.64 to -2.14	-2.57 units on a scale Interval -2.82 to -2.31
Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Week 16 and 24 Week 24	-1.30 units on a scale Interval -1.57 to -1.04	-2.94 units on a scale Interval -3.2 to -2.68	-3.09 units on a scale Interval -3.35 to -2.83

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24

Population: Analysis population is FAS1. Data after meeting 1 or more TF criteria were imputed as no change from baseline. Missing data were assumed missing at random. The LS mean is based on MMRM model that included data from all visits for all participants included in the model.

DAPSA assessed the joint domain of PsA and was derived from the sum of the following components: tender joint count (0-68), swollen joint count (0-66), CRP level (mg/dL, value <lower limit of quantification [LLOQ] is considered equal to half of the value of LLOQ for numerical calculations), patient assessment of pain (0-10cm VAS, 0=no pain, 10=worst possible pain), and patient's global assessment of disease activity on arthritis (0 to 10cm VAS, 0=excellent and 10=poor). A higher score indicates more active disease activity. Negative changes from baseline indicate improvement of PsA disease activity. The assessment does not have a score range with an upper or lower bound.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=246 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=248 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=245 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 2	-4.6447 units on a scale Interval -5.9287 to -3.3607	-6.7838 units on a scale Interval -8.0642 to -5.5034	-6.3783 units on a scale Interval -7.6664 to -5.0902
Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 4	-7.6695 units on a scale Interval -9.2194 to -6.1197	-9.9687 units on a scale Interval -11.5128 to -8.4246	-10.2484 units on a scale Interval -11.8049 to -8.6919
Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 8	-10.4480 units on a scale Interval -12.1877 to -8.7084	-15.3303 units on a scale Interval -17.0682 to -13.5924	-15.8657 units on a scale Interval -17.6038 to -14.1277
Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 12	-14.2915 units on a scale Interval -16.1107 to -12.4724	-18.9772 units on a scale Interval -20.7912 to -17.1632	-19.9687 units on a scale Interval -21.7915 to -18.1459
Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 16	-14.8556 units on a scale Interval -16.8664 to -12.8448	-21.6939 units on a scale Interval -23.6979 to -19.6899	-21.4722 units on a scale Interval -23.4873 to -19.4571
Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 20	-16.1375 units on a scale Interval -18.1165 to -14.1586	-23.3163 units on a scale Interval -25.289 to -21.3436	-24.6844 units on a scale Interval -26.6691 to -22.6997
Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, 16, 20 and 24 Week 24	-15.8489 units on a scale Interval -17.9229 to -13.775	-24.0359 units on a scale Interval -26.1019 to -21.9699	-25.1583 units on a scale Interval -27.2341 to -23.0824

SECONDARY outcome

Timeframe: Weeks 16 and 24

Population: Analysis population is FAS1. Participants who achieved MDA at a specific time point and did not meet any TF criteria before, were considered as responders at that time point. Participants who met 1 or more TF criteria before or with missing data at that time point were considered as non-responders.

MDA is a measure that defines a satisfactory state of disease activity that includes the 5 domains of PsA (joint symptoms, skin psoriasis, patient's perspective of pain and disease activity, physical function, and enthesitis). A participant was considered as having achieved the PsA MDA at a visit if the participant has fulfilled at least 5 of the following 7 criteria at that visit: Tender joint count (68 joints)<=1, Swollen joint count (66 joints) <=1, Psoriasis activity and severity index <=1, Patient's Assessment of Pain <=15 on a 100-unit VAS, Patient's Global Assessment of Disease Activity (arthritis and psoriasis) <=20 on a 100-unit VAS, HAQ-DI score <=0.5, and Tender entheseal points <= 1 (LEI index score <= 1).

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=246 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=248 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=245 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved Minimal Disease Activity (MDA) Criteria Through Week 24 Week 24	6.1 percentage of participants	25.0 percentage of participants	18.8 percentage of participants
Percentage of Participants Who Achieved Minimal Disease Activity (MDA) Criteria Through Week 24 Week 16	3.3 percentage of participants	16.9 percentage of participants	13.1 percentage of participants

SECONDARY outcome

Timeframe: Weeks 8, 16 and 24

Population: FAS1 with spondylitis and peripheral arthritis and BASDAI score \>0 at baseline. Participants with the specified improvement in BASDAI at specific time point and did not meet TF criteria before, considered responders at that time point. Participants who met 1/more TF criteria before or with missing data at that time point considered non-responders.

Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a self-assessment tool that consists of 6 questions relating to the 5 major symptoms of ankylosing spondylitis: fatigue, spinal pain, joint pain, enthesitis, qualitative morning stiffness and quantitative morning stiffness. The first 5 items were scored on a 10 centimeter (cm) VAS ranging from 0=none to 10=very severe. Quantitative morning stiffness was scored on a 10cm VAS ranging from 0=0 hours to 10=2 or more hours. The 2 scores for qualitative and quantitative morning stiffness were averaged, and the total BASDAI score was the average of the 5 scores of each symptom, ranging from 0 (none) to 10 (very severe). Higher scores indicate greater disease severity and an improvement of 50% from baseline is considered clinically meaningful. Only participants with spondylitis and peripheral arthritis as their primary arthritic presentation of PsA completed the BASDAI indicate the degree of their symptoms over the past week.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=92 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=67 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=83 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score Through Week 24 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline Week 16: Participants with >=20% Improvement	39.1 percentage of participants	58.2 percentage of participants	69.9 percentage of participants
Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score Through Week 24 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline Week 24: Participants with >=20% Improvement	42.4 percentage of participants	59.7 percentage of participants	68.7 percentage of participants
Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score Through Week 24 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline Week 8: Participants with >=50% Improvement	6.5 percentage of participants	17.9 percentage of participants	18.1 percentage of participants
Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score Through Week 24 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline Week 16: Participants with >=50% Improvement	17.4 percentage of participants	37.3 percentage of participants	26.5 percentage of participants
Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score Through Week 24 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline Week 24: Participants with >=50% Improvement	21.7 percentage of participants	38.8 percentage of participants	37.3 percentage of participants
Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score Through Week 24 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline Week 8: Participants with >=70% Improvement	3.3 percentage of participants	11.9 percentage of participants	4.8 percentage of participants
Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score Through Week 24 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline Week 16: Participants with >=70% Improvement	5.4 percentage of participants	23.9 percentage of participants	9.6 percentage of participants
Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score Through Week 24 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline Week 24: Participants with >=70% Improvement	8.7 percentage of participants	20.9 percentage of participants	15.7 percentage of participants
Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score Through Week 24 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline Week 8: Participants with >=90% Improvement	0 percentage of participants	1.5 percentage of participants	0 percentage of participants
Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score Through Week 24 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline Week 16: Participants with >=90% Improvement	1.1 percentage of participants	0 percentage of participants	2.4 percentage of participants
Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score Through Week 24 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline Week 24: Participants with >=90% Improvement	2.2 percentage of participants	1.5 percentage of participants	3.6 percentage of participants
Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score Through Week 24 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline Week 8: Participants with >=20% Improvement	38.0 percentage of participants	46.3 percentage of participants	53.0 percentage of participants

SECONDARY outcome

Timeframe: Weeks 16 and 24

Population: FAS1 among participants with \>=3% BSA of psoriasis and IGA score \>=2 at baseline. Participants with PASI 75 response at specific time point and did not meet any TF criteria before, were considered responders at that time point. Participants who met 1/more TF criteria before or with missing data at that time point were considered non-responders.

PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. A PASI 75 response: >=75% improvement in PASI score from baseline.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=183 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=176 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=184 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved PASI 75 Response Through Week 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 16	18.6 percentage of participants	73.3 percentage of participants	73.9 percentage of participants
Percentage of Participants Who Achieved PASI 75 Response Through Week 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 24	23.0 percentage of participants	79.0 percentage of participants	78.3 percentage of participants

SECONDARY outcome

Timeframe: Weeks 16 and 24

Population: FAS1 among participants with \>=3% BSA of psoriasis and IGA score \>=2 at baseline. Participants with PASI 90 response at specific time point and did not meet any TF criteria before, were considered responders at that time point. Participants who met 1 or more TF criteria before or with missing data at that time point were considered non-responders.

PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. A PASI 90 response: >=90% improvement in PASI score from baseline.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=183 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=176 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=184 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved PASI 90 Response Through Week 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 16	8.2 percentage of participants	55.1 percentage of participants	53.8 percentage of participants
Percentage of Participants Who Achieved PASI 90 Response Through Week 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 24	9.8 percentage of participants	68.8 percentage of participants	60.9 percentage of participants

SECONDARY outcome

Timeframe: Weeks 16 and 24

Population: FAS1 among participants with \>=3% BSA of psoriasis and IGA score \>=2 at baseline. Participants with PASI 100 response at specific time point and did not meet any TF criteria before, were considered responders at that time point. Participants who met 1/more TF criteria before or with missing data at that time point were considered non-responders.

PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. A PASI 100 response: 100% improvement in PASI score from baseline.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=183 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=176 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=184 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved PASI 100 Response Through Week 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline Week 24	2.7 percentage of participants	45.5 percentage of participants	44.6 percentage of participants
Percentage of Participants Who Achieved PASI 100 Response Through Week 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline Week 16	3.8 percentage of participants	27.3 percentage of participants	33.2 percentage of participants

SECONDARY outcome

Timeframe: Weeks 16 and 24

Population: FAS1 among participants with \>=3% BSA of psoriasis and IGA score \>=2 at baseline. Participants with IGA score of 0(cleared) at specific time point and did not meet TF criteria before, were considered responders at that time point. Participants who met 1/more TF criteria before or with missing data at that time point were considered non-responders.

A psoriasis IGA response was defined as an IGA score of 0 (cleared) or 1 (minimal) and >=2 grade reduction from baseline in the IGA psoriasis score. The IGA documents the investigator's assessment of the patient's psoriasis and lesions are graded for induration, erythema and scaling, each using a 5 point scale: 0 (no evidence), 1 (minimal), 2 (mild), 3 (moderate), and 4 (severe). The IGA score of psoriasis was based upon the average of induration, erythema and scaling scores. The participant's psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=183 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=176 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=184 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants With an IGA Score of 0 (Cleared) Through Week 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 16	6.0 percentage of participants	38.6 percentage of participants	40.8 percentage of participants
Percentage of Participants With an IGA Score of 0 (Cleared) Through Week 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 24	7.7 percentage of participants	50.0 percentage of participants	51.5 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 16 and 24

Population: FAS1 among participants who had \>=3% BSA of psoriatic involvement and IGA score \>=2 (mild) at baseline. Data after meeting one or more TF criteria were imputed as no change from baseline. Missing data were assumed to be MAR. The LS mean is based on MMRM model that included data from all visits for all participants included in the model.

PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. Negative change from baseline indicates improvement of psoriasis.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=183 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=176 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=184 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in PASI Score at Weeks 16 and 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 16	-3.482 units on a scale Interval -4.346 to -2.618	-11.151 units on a scale Interval -12.028 to -10.274	-11.278 units on a scale Interval -12.153 to -10.404
Change From Baseline in PASI Score at Weeks 16 and 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 24	-3.904 units on a scale Interval -4.748 to -3.059	-11.407 units on a scale Interval -12.265 to -10.549	-11.471 units on a scale Interval -12.325 to -10.617

SECONDARY outcome

Timeframe: Weeks 8, 16, 24

Population: FAS1 among participants with DLQI \>1, \>=3% BSA of psoriasis and IGA score \>=2 (mild) at baseline. Participants with DLQI score of 0/1 at specific time point and did not meet TF criteria before, considered responders at that time point. Participants who met 1/more TF criteria before or with missing data at that time point considered non-responders.

Dermatology Life Quality Index (DLQI) is a 10-item instrument questionnaire used to assess the patient's perspective of the impact of psoriasis on daily living. Each item was scored on a 4-point scale (0 =not at all /not relevant; 1 =a little; 2 =a lot; 3 =very much), and the total score (0-30) is the sum of the 10 items. The higher the score, the more quality of life is impaired. A DLQI score of 0 or 1 indicates psoriasis had no effect at all on patient's life.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=170 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=158 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=173 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved a DLQI Score of 0 or 1 Through Week 24 Among the Participants With DLQI Score >1, With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 8	7.6 percentage of participants	33.5 percentage of participants	26.6 percentage of participants
Percentage of Participants Who Achieved a DLQI Score of 0 or 1 Through Week 24 Among the Participants With DLQI Score >1, With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 16	10.0 percentage of participants	51.3 percentage of participants	45.1 percentage of participants
Percentage of Participants Who Achieved a DLQI Score of 0 or 1 Through Week 24 Among the Participants With DLQI Score >1, With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 24	11.8 percentage of participants	63.9 percentage of participants	59.0 percentage of participants

SECONDARY outcome

Timeframe: Weeks 8, 16, 24

Population: FAS1 with DLQI\>=5, \>=3% BSA of psoriasis and IGA score \>=2 (mild) at baseline. Participants with \>=5-point improvement from baseline in DLQI score at specific time point and did not meet TF criteria before, considered responders at that time point. Participants who met 1/more TF criteria before or with missing data considered non-responders.

Dermatology Life Quality Index (DLQI) is a 10-item instrument questionnaire used to assess the patient's perspective of the impact of psoriasis on daily living. Each item was scored on a 4-point scale (0 =not at all /not relevant; 1 =a little; 2 =a lot; 3 =very much), and the total score (0-30) is the sum of the 10 items. The higher the score, the more quality of life is impaired. An improvement of 5 points was considered clinically meaningful.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=143 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=132 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=152 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved >=5-point Improvement From Baseline in DLQI Score Through Week 24 Among the Participants With DLQI Score >=5, >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 8	30.1 percentage of participants	71.2 percentage of participants	69.7 percentage of participants
Percentage of Participants Who Achieved >=5-point Improvement From Baseline in DLQI Score Through Week 24 Among the Participants With DLQI Score >=5, >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 16	36.4 percentage of participants	79.5 percentage of participants	79.6 percentage of participants
Percentage of Participants Who Achieved >=5-point Improvement From Baseline in DLQI Score Through Week 24 Among the Participants With DLQI Score >=5, >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 24	37.8 percentage of participants	83.3 percentage of participants	86.8 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 8, 16 and 24

Population: Analysis population is FAS1 among participants with \>=3% BSA of psoriasis and an IGA score \>=2 (mild) at baseline. Data after meeting 1 or more TF criteria were imputed as no change from baseline. Missing data were assumed missing at random. LS mean is based on MMRM model that included data from all visits for all participants included in model.

Dermatology Life Quality Index (DLQI) is a 10-item instrument questionnaire used to assess the patient's perspective of the impact of psoriasis on daily living. Each item was scored on a 4-point scale (0 =not at all /not relevant; 1 =a little; 2 =a lot; 3 =very much), and the total score (0-30) is the sum of the 10 items. The higher the score, the more quality of life is impaired. Negative changes from baseline indicate improvement of life quality impacted by psoriasis.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=183 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=176 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=184 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in DLQI Score at Weeks 8, 16 and 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 8	-1.653 units on a scale Interval -2.373 to -0.933	-6.818 units on a scale Interval -7.549 to -6.086	-6.396 units on a scale Interval -7.121 to -5.671
Change From Baseline in DLQI Score at Weeks 8, 16 and 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 16	-2.410 units on a scale Interval -3.109 to -1.71	-8.545 units on a scale Interval -9.255 to -7.835	-8.147 units on a scale Interval -8.853 to -7.441
Change From Baseline in DLQI Score at Weeks 8, 16 and 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 24	-2.129 units on a scale Interval -2.854 to -1.404	-8.954 units on a scale Interval -9.691 to -8.218	-8.853 units on a scale Interval -9.581 to -8.124

SECONDARY outcome

Timeframe: Weeks 16 and 24

Population: FAS1 participants with \>=3% BSA psoriatic involvement and IGA score \>=2 at baseline. Participants with both PASI75 and ACR20 responses at specific timepoint and did not meet TF criteria before, considered responders at that time point. Participants who met 1/more TF criteria before or with missing data at that time point considered non-responders.

In PASI, each area (head, trunk, upper and lower extremities) was assessed for % of area involved and translated to numeric score from 0 (no involvement) to 6 (90-100% involvement) and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI produces numeric score from 0 to 72. Higher scores=more severe disease. PASI 75: >=75% improvement in PASI score from baseline. ACR 20: >=20% improvement in swollen joint count (SJC) (66 joints) + tender joint count (TJC) (68 joints) and >=20% improvement in 3 of 5: patient's assessment of pain (VAS; 0-100 mm, 0=no pain to 100=worst possible pain), PtGA of disease activity (VAS; 0-100 mm, 0=excellent to 100=poor), PGA of disease activity (VAS; 0-100 mm, 0=no arthritis to 100=extremely active arthritis), patient's assessment of physical function (HAQ-DI -20-question instrument; range- 0=no difficulty to 3=inability to perform task) and CRP.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=183 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=176 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=184 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved Both PASI 75 and ACR 20 Responses Through Week 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 16	10.4 percentage of participants	48.9 percentage of participants	48.4 percentage of participants
Percentage of Participants Who Achieved Both PASI 75 and ACR 20 Responses Through Week 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 24	11.5 percentage of participants	56.8 percentage of participants	57.1 percentage of participants

SECONDARY outcome

Timeframe: Weeks 16 and 24

Population: FAS1 with \>=3% BSA psoriatic involvement and IGA score \>=2 at baseline. Participants with both PASI 75 and modified PsARC responses at specific timepoint and did not meet TF criteria before, considered responders at that time point. Participants who met 1/more TF criteria before or with missing data at that time point considered non-responders.

In PASI, each area (head, trunk, upper and lower extremities) was assessed separately for % of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90-100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI produces numeric score range from 0 to 72. Higher scores=more severe disease. PASI 75 response: >=75% improvement in PASI score from baseline. Modified PsARC response: improvement in at least 2 of 4 criteria: >=30% decrease in SJC and TJC, >=20% improvement in PtGA of Disease Activity (arthritis) on VAS (0-100 mm, 0=excellent and 100=poor), >=20% improvement in PGA of Disease Activity on VAS (VAS: 0-100 mm, 0=no arthritis and 100=extremely active arthritis), and at least 1 of 2 joint criteria with no deterioration in other criteria.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=183 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=176 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=184 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved Both PASI 75 and Modified PsARC Response Through Week 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 16	13.1 percentage of participants	56.8 percentage of participants	54.3 percentage of participants
Percentage of Participants Who Achieved Both PASI 75 and Modified PsARC Response Through Week 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 24	15.3 percentage of participants	65.3 percentage of participants	60.9 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Analysis population is FAS1-SD. Observed data were used regardless if 1 or more TF criteria were met. Missing data were assumed to be missing at random and imputed using multiple imputation.

Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=246 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=248 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=245 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in Modified vdH-S Erosion Score at Week 24	0.58 units on a scale Interval 0.33 to 0.83	0.36 units on a scale Interval 0.11 to 0.61	0.13 units on a scale Interval -0.12 to 0.38

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Analysis population is FAS1-SD. Observed data were used regardless if 1 or more TF criteria were met. Missing data were assumed to be missing at random and imputed using multiple imputation.

The modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). The JSN score is the total JSN score in 40 joints of the two hands and 12 joints of the 2 feet. Each joint is scored from 0 to 4 with 0 indicating no JSN, and 4 indicating a complete loss of joint space, bony ankylosis, or complete luxation, for a maximum JSN score of 208. Higher score indicates more severe joint space narrowing. A positive change from baseline in the modified vdH-S JSN score indicates progression of joint space narrowing.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=246 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=248 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=245 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in Modified vdH-S Joint Space Narrowing (JSN) Score at Week 24	0.37 units on a scale Interval 0.23 to 0.51	0.16 units on a scale Interval 0.02 to 0.3	0.16 units on a scale Interval 0.02 to 0.3

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Analysis population is FAS1-SD. Observed data were summarized regardless if 1 or more TF criteria were met. Here, 'n' (number analyzed) signifies the number of participants analyzed for a specified score.

Modified vdH-S score is the sum of the erosion score (hand, feet) and JSN score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand (Hand erosion score) scored according to 0 (no erosion) to 5 (complete collapse of bone) for a maximum hand erosion score of 200, and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum foot erosion score of 120. Higher scores indicate more joint damage. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum Hand JSN score of 160 and maximum Foot JSN score of 48. Higher scores indicate more joint damage. Hand Score (sum of Hand Erosion Score and Hand JSN Score) scored as 0-360 and Foot score (sum of foot erosion score and foot JSN score) scored as 0-168. Higher scores indicate more joint damage.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=246 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=248 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=245 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) at Week 24 Hand Erosion Score	0.40 units on a scale Standard Deviation 1.555	0.18 units on a scale Standard Deviation 1.280	-0.03 units on a scale Standard Deviation 1.514
Change From Baseline in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) at Week 24 Hand JSN Score	0.26 units on a scale Standard Deviation 1.106	0.10 units on a scale Standard Deviation 0.637	0.08 units on a scale Standard Deviation 0.607
Change From Baseline in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) at Week 24 Hand Score	0.66 units on a scale Standard Deviation 2.441	0.28 units on a scale Standard Deviation 1.649	0.05 units on a scale Standard Deviation 1.881
Change From Baseline in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) at Week 24 Foot Erosion Score	0.14 units on a scale Standard Deviation 0.801	0.15 units on a scale Standard Deviation 0.982	0.14 units on a scale Standard Deviation 0.894
Change From Baseline in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) at Week 24 Foot JSN Score	0.10 units on a scale Standard Deviation 0.516	0.02 units on a scale Standard Deviation 0.516	0.07 units on a scale Standard Deviation 0.632
Change From Baseline in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) at Week 24 Foot Score	0.24 units on a scale Standard Deviation 1.116	0.17 units on a scale Standard Deviation 1.180	0.21 units on a scale Standard Deviation 1.210

SECONDARY outcome

Timeframe: Week 24

Population: Analysis population is FAS1-SD. Observed data were used regardless if 1 or more TF criteria were met. Missing data were assumed to be missing at random and imputed using multiple imputation.

Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=246 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=248 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=245 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Score at Week 24 Change of <=0 from Baseline	64.7 percentage of participants	63.5 percentage of participants	67.3 percentage of participants
Percentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Score at Week 24 Change of <=0.5 from Baseline	72.1 percentage of participants	74.4 percentage of participants	78.0 percentage of participants

SECONDARY outcome

Timeframe: Week 24

Population: Analysis population is FAS1-SD. Observed data were used regardless if 1 or more TF criteria were met. Missing data were assumed to be missing at random and imputed using multiple imputation.

Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=246 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=248 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=245 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants With a Change of <=0 From Baseline and <=0.5 From Baseline in Modified vdH-S Erosion Score at Week 24 Change of <=0 from Baseline	66.8 percentage of participants	66.3 percentage of participants	71.4 percentage of participants
Percentage of Participants With a Change of <=0 From Baseline and <=0.5 From Baseline in Modified vdH-S Erosion Score at Week 24 Change of <=0.5 from Baseline	72.9 percentage of participants	76.8 percentage of participants	80.2 percentage of participants

SECONDARY outcome

Timeframe: Week 24

Population: Analysis population is FAS1-SD. Observed data were used regardless if 1 or more TF criteria were met. Missing data were assumed to be missing at random and imputed using multiple imputation.

The modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). The JSN score is the sum of JSN score in 40 joints of the two hands and 12 joints of the 2 feet. Each joint is scored from 0 - 4 with 0 indicating no JSN, and 4 indicating a complete loss of joint space, bony ankylosis, or complete luxation, for a maximum JSN score of 208. Higher score indicates more severe joint space narrowing. Change from baseline in the modified vdH-S JSN score <=0 (assessed by both readers) or <=0.5 (assessed by at least one reader) was considered as no progression of JSN.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=246 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=248 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=245 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants With a Change of <=0 From Baseline and <=0.5 From Baseline in Modified vdH-S JSN Score at Week 24 Change of <=0 from Baseline	78.6 percentage of participants	78.8 percentage of participants	80.1 percentage of participants
Percentage of Participants With a Change of <=0 From Baseline and <=0.5 From Baseline in Modified vdH-S JSN Score at Week 24 Change of <=0.5 from Baseline	85.5 percentage of participants	88.1 percentage of participants	88.3 percentage of participants

SECONDARY outcome

Timeframe: Week 24

Population: Analysis population is FAS1-SD. Observed data were used regardless if 1 or more TF criteria were met. Missing data were assumed to be missing at random and imputed using multiple imputation.

Modified vdH-S score is the sum of the erosion score (hand, feet) and JSN score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. SDC was defined as the cut-off above which the changes can be detected beyond measurement error. Without radiographic progression was defined as change from baseline in the modified vdH-S score <=SDC of 2.18.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=246 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=248 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=245 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Without Radiographic Progression (Based on the Smallest Detectable Change [SDC]) From Baseline at Week 24	86.4 percentage of participants	87.8 percentage of participants	89.3 percentage of participants

SECONDARY outcome

Timeframe: Week 24

Population: Analysis population is FAS1-SD. Observed data were used regardless if 1 or more TF criteria were met. Missing data were assumed to be missing at random and imputed using multiple imputation.

Modified vdH-S score is sum of erosion score (hand, feet) and JSN score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. SDC defined as the cut-off above which changes can be detected beyond measurement error. Without radiographic joint erosion progression was defined as change from baseline in modified vdH-S erosion score <=SDC of 1.83.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=246 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=248 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=245 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Without Radiographic Joint Erosion Progression (Based on SDC) From Baseline at Week 24	84.0 percentage of participants	89.0 percentage of participants	89.9 percentage of participants

SECONDARY outcome

Timeframe: Week 24

Population: Analysis population is FAS1-SD. Observed data were used regardless if 1 or more TF criteria were met. Missing data were assumed to be missing at random and imputed using multiple imputation.

The modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). The JSN score is the sum of JSN score in 40 joints of the two hands and 12 joints of the 2 feet. Each joint is scored from 0 - 4 with 0 indicating no JSN, and 4 indicating a complete loss of joint space, bony ankylosis, or complete luxation, for a maximum JSN score of 208. Higher score indicates more severe joint space narrowing. The smallest detectable change (SDC) was defined as the cut-off above which the changes can be detected beyond measurement error. Without radiographic JSN progression was defined as change from baseline in the modified vdH-S JSN score <=SDC of 1.11.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=246 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=248 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=245 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Without Radiographic JSN Progression (Based on the SDC) From Baseline at Week 24	91.3 percentage of participants	93.5 percentage of participants	91.7 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Analysis population is FAS1-SD. Observed data were summarized regardless if 1 or more TF criteria were met.

Pencil in Cup or Gross Osteolytis Deformities are radiographic features specific for psoriatic arthritis.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=246 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=248 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=245 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline and Week 24 Baseline	4.5 percentage of participants	3.6 percentage of participants	3.7 percentage of participants
Percentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline and Week 24 Week 24	4.9 percentage of participants	3.6 percentage of participants	3.8 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 8, 16 and 24

Population: Analysis population is FAS1. Data after meeting one or more TF criteria were imputed as no change from baseline. Missing data were assumed to be missing at random (MAR) and imputed using multiple imputation (MI).

SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The PCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=246 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=248 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=245 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in SF-36 PCS Score at Weeks 8, 16 and 24 Week 8	2.75 units on a scale Interval 1.98 to 3.52	4.83 units on a scale Interval 4.06 to 5.59	4.34 units on a scale Interval 3.56 to 5.1
Change From Baseline in SF-36 PCS Score at Weeks 8, 16 and 24 Week 16	3.03 units on a scale Interval 2.18 to 3.88	6.65 units on a scale Interval 5.8 to 7.49	5.93 units on a scale Interval 5.07 to 6.78
Change From Baseline in SF-36 PCS Score at Weeks 8, 16 and 24 Week 24	3.42 units on a scale Interval 2.53 to 4.32	7.39 units on a scale Interval 6.5 to 8.29	7.04 units on a scale Interval 6.14 to 7.94

SECONDARY outcome

Timeframe: Baseline, Weeks 8, 16 and 24

Population: Analysis population is FAS1. Data after meeting one or more TF criteria were imputed as no change from baseline. Missing data were assumed to be missing at random (MAR) and imputed using multiple imputation (MI).

SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The MCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=246 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=248 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=245 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in SF-36 MCS Score at Weeks 8, 16 and 24 Week 8	1.11 units on a scale Interval 0.12 to 2.09	2.28 units on a scale Interval 1.3 to 3.27	2.87 units on a scale Interval 1.89 to 3.86
Change From Baseline in SF-36 MCS Score at Weeks 8, 16 and 24 Week 16	1.96 units on a scale Interval 0.91 to 3.01	4.28 units on a scale Interval 3.24 to 5.33	3.41 units on a scale Interval 2.36 to 4.47
Change From Baseline in SF-36 MCS Score at Weeks 8, 16 and 24 Week 24	2.14 units on a scale Interval 1.07 to 3.22	4.17 units on a scale Interval 3.1 to 5.23	4.22 units on a scale Interval 3.14 to 5.29

SECONDARY outcome

Timeframe: Baseline and Weeks 8, 16 and 24

Population: Analysis population is FAS1. Data after meeting one or more TF criteria were imputed as no change from baseline. Missing data were assumed to be MAR. The LS mean is based on MMRM model that included data from all visits for all participants included in the model.

SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales: physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health. The scores 0-100 (where higher scores indicated a better quality of life) from each subscale of SF-36 were normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. Higher score indicates better health status. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=246 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=248 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=245 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 Week 8: Physical Function Score	2.095 units on a scale Interval 1.251 to 2.94	3.879 units on a scale Interval 3.038 to 4.72	3.936 units on a scale Interval 3.09 to 4.782
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 Week 16: Physical Function Score	2.581 units on a scale Interval 1.669 to 3.492	6.124 units on a scale Interval 5.218 to 7.03	5.618 units on a scale Interval 4.704 to 6.532
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 Week 24: Physical Function Score	3.254 units on a scale Interval 2.31 to 4.197	6.703 units on a scale Interval 5.764 to 7.642	6.624 units on a scale Interval 5.68 to 7.567
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 Week 8: Role-physical Score	2.619 units on a scale Interval 1.828 to 3.41	3.599 units on a scale Interval 2.812 to 4.387	3.107 units on a scale Interval 2.315 to 3.899
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 Week 16: Role-physical Score	2.965 units on a scale Interval 2.12 to 3.81	5.616 units on a scale Interval 4.776 to 6.455	4.942 units on a scale Interval 4.095 to 5.789
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 Week 24: Role-physical Score	3.365 units on a scale Interval 2.477 to 4.253	6.549 units on a scale Interval 5.666 to 7.433	6.241 units on a scale Interval 5.354 to 7.129
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 Week 8: Bodily Pain Score	2.760 units on a scale Interval 1.974 to 3.546	5.456 units on a scale Interval 4.674 to 6.239	4.901 units on a scale Interval 4.115 to 5.688
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 Week 16: Bodily Pain Score	3.086 units on a scale Interval 2.196 to 3.977	7.485 units on a scale Interval 6.601 to 8.369	6.613 units on a scale Interval 5.721 to 7.505
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 Week 24: Bodily Pain Score	3.482 units on a scale Interval 2.556 to 4.408	7.811 units on a scale Interval 6.89 to 8.733	7.739 units on a scale Interval 6.813 to 8.664
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 Week 8: General Health Score	1.662 units on a scale Interval 0.906 to 2.418	4.111 units on a scale Interval 3.358 to 4.863	4.174 units on a scale Interval 3.418 to 4.931
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 Week 16: General Health Score	2.520 units on a scale Interval 1.681 to 3.358	5.719 units on a scale Interval 4.886 to 6.552	4.808 units on a scale Interval 3.967 to 5.648
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 Week 24: General Health Score	2.290 units on a scale Interval 1.415 to 3.165	5.794 units on a scale Interval 4.924 to 6.665	5.269 units on a scale Interval 4.394 to 6.144
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 Week 8: Vitality Score	2.505 units on a scale Interval 1.574 to 3.436	4.286 units on a scale Interval 3.358 to 5.213	4.669 units on a scale Interval 3.736 to 5.601
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 Week 16: Vitality Score	3.554 units on a scale Interval 2.559 to 4.548	6.967 units on a scale Interval 5.98 to 7.955	5.901 units on a scale Interval 4.904 to 6.898
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 Week 24: Vitality Score	3.835 units on a scale Interval 2.755 to 4.914	7.373 units on a scale Interval 6.299 to 8.447	7.009 units on a scale Interval 5.929 to 8.088
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 Week 8: Social Function Score	1.929 units on a scale Interval 0.976 to 2.882	3.337 units on a scale Interval 2.387 to 4.286	4.306 units on a scale Interval 3.352 to 5.26
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 Week 16: Social Function Score	2.884 units on a scale Interval 1.853 to 3.915	5.584 units on a scale Interval 4.56 to 6.609	5.022 units on a scale Interval 3.989 to 6.055
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 Week 24: Social Function Score	2.978 units on a scale Interval 1.964 to 3.992	5.806 units on a scale Interval 4.796 to 6.816	5.922 units on a scale Interval 4.909 to 6.936
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 Week 8: Role-emotional Score	1.108 units on a scale Interval 0.095 to 2.121	2.459 units on a scale Interval 1.451 to 3.468	2.294 units on a scale Interval 1.28 to 3.307
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 Week 16: Role-emotional Score	1.530 units on a scale Interval 0.499 to 2.562	4.497 units on a scale Interval 3.472 to 5.522	3.596 units on a scale Interval 2.563 to 4.63
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 Week 24: Role-emotional Score	1.813 units on a scale Interval 0.793 to 2.834	4.382 units on a scale Interval 3.367 to 5.398	4.255 units on a scale Interval 3.235 to 5.275
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 Week 8: Mental Health Score	1.081 units on a scale Interval 0.137 to 2.025	2.380 units on a scale Interval 1.44 to 3.32	3.048 units on a scale Interval 2.104 to 3.992
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 Week 16: Mental Health Score	2.195 units on a scale Interval 1.204 to 3.185	4.529 units on a scale Interval 3.546 to 5.513	3.896 units on a scale Interval 2.905 to 4.888
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 Week 24: Mental Health Score	2.335 units on a scale Interval 1.314 to 3.356	4.490 units on a scale Interval 3.474 to 5.506	4.767 units on a scale Interval 3.747 to 5.788

SECONDARY outcome

Timeframe: Week 8, 16 and 24

Population: Analysis population is FAS1. Participants who achieved \>=5-point improvement from baseline in SF-36 MCS score at specific time point and did not meet any TF criteria before, were considered as responders at that time point. Participants who met 1 or more TF criteria before or with missing data at that time point were considered as non-responders.

SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The MCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. Higher score indicates better outcome, with an increase of 5 points considered to be clinically meaningful.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=246 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=248 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=245 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score Through Week 24 Week 8	26.4 percentage of participants	33.1 percentage of participants	27.3 percentage of participants
Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score Through Week 24 Week 16	31.7 percentage of participants	42.3 percentage of participants	31.8 percentage of participants
Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score Through Week 24 Week 24	30.9 percentage of participants	37.5 percentage of participants	34.3 percentage of participants

SECONDARY outcome

Timeframe: Week 8, 16 and 24

Population: Analysis population is FAS1. Participants who achieved \>=5-point improvement from baseline in SF-36 PCS score at specific time point and did not meet any TF criteria before, were considered as responders at that time point. Participants who met 1 or more TF criteria before or with missing data at that time point were considered as non-responders.

SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The PCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. Higher score indicates better outcome, with an increase of 5 points considered to be clinically meaningful.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=246 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=248 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=245 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score Through Week 24 Week 8	37.8 percentage of participants	45.2 percentage of participants	41.2 percentage of participants
Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score Through Week 24 Week 16	35.8 percentage of participants	59.3 percentage of participants	51.0 percentage of participants
Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score Through Week 24 Week 24	40.2 percentage of participants	60.1 percentage of participants	55.9 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 8, 16 and 24

Population: Analysis population is FAS1. Data after meeting 1 or more TF criteria were imputed as no change from baseline. Missing data were assumed MAR. The LS mean is based on MMRM model that included data from all visits for all participants included in the model.

The FACIT-Fatigue is a questionnaire that assesses self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue. The subscale consists 13-item instrument to measure fatigue. Each of the 13 items has a set of five response categories: Not at all (=0), A little bit (=1), Somewhat (=2), Quite a bit (=3) and Very much (=4). A total FACIT-Fatigue subscale score was calculated as the sum of the 13 item scores (reserved scores [4 - score]) and ranges from 0 to 52, with a higher score indicating less fatigue. Positive changes from baseline indicate improvement of fatigue. Items were reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatigue.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=246 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=248 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=245 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 8, 16, and 24 Week 8	2.451 units on a scale Interval 1.508 to 3.395	5.031 units on a scale Interval 4.092 to 5.97	4.850 units on a scale Interval 3.905 to 5.795
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 8, 16, and 24 Week 16	3.696 units on a scale Interval 2.675 to 4.717	6.977 units on a scale Interval 5.963 to 7.992	6.598 units on a scale Interval 5.574 to 7.622
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 8, 16, and 24 Week 24	3.559 units on a scale Interval 2.5 to 4.619	7.550 units on a scale Interval 6.496 to 8.603	7.111 units on a scale Interval 6.051 to 8.171

SECONDARY outcome

Timeframe: Weeks 8, 16 and 24

Population: Analysis population is FAS1. Participants who achieved \>=4-point improvement from baseline in FACIT-fatigue score at specific time point and did not meet any TF criteria before, were considered responders at that time point. Participants who met 1 or more TF criteria before or with missing data at that time point were considered non-responders.

The FACIT-Fatigue is a questionnaire that assesses self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue. The subscale consists 13-item instrument to measure fatigue. Each of the 13 items has a set of five response categories: Not at all (=0), A little bit (=1), Somewhat (=2), Quite a bit (=3) and Very much (=4). A total FACIT-Fatigue subscale score was calculated as the sum of the 13 item scores (reserved scores [4 - score]) and ranges from 0 to 52, with a higher score indicating less fatigue. Items were reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatigue.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=246 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=248 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=245 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score Improvement Through Week 24 Week 8	45.9 percentage of participants	56.0 percentage of participants	51.8 percentage of participants
Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score Improvement Through Week 24 Week 16	50.4 percentage of participants	60.9 percentage of participants	56.7 percentage of participants
Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score Improvement Through Week 24 Week 24	45.5 percentage of participants	60.5 percentage of participants	59.6 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 16 and 24

Population: Analysis population is FAS1. Data after meeting 1 or more TF criteria were imputed as no change from baseline. Missing data were assumed missing at random. The LS mean is based on MMRM model that included data from all visits for all participants included in the model.

EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. The EQ VAS self-rating records the respondent's own assessment of his or her overall health status at the time of completion, on a vertical line VAS with scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine). A higher score indicates better health and positive changes from baseline indicate improvement of health status

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=246 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=248 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=245 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) at Weeks 16 and 24: EQ-VAS Week 16	6.477 units on a scale Interval 4.013 to 8.941	17.496 units on a scale Interval 15.049 to 19.943	14.646 units on a scale Interval 12.179 to 17.112
Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) at Weeks 16 and 24: EQ-VAS Week 24	6.796 units on a scale Interval 4.298 to 9.294	18.371 units on a scale Interval 15.89 to 20.852	18.089 units on a scale Interval 15.596 to 20.581

SECONDARY outcome

Timeframe: Baseline, Weeks 16 and 24

Population: Analysis population is FAS1. Data after meeting 1 or more TF criteria were imputed as no change from baseline. Missing data were assumed missing at random. The LS mean is based on MMRM model that included data from all visits for all participants included in the model.

EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health "today". Responses were used to generate a weighted summary index (EQ-5D index), which ranges from 0 (dead) to 1.00 (full health). A higher score indicates better health and positive changes from baseline indicate improvement of health.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=246 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=248 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=245 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in EQ-5D-5L at Weeks 16 and 24: EQ-5D Index Week 16	0.058 units on a scale Interval 0.043 to 0.074	0.112 units on a scale Interval 0.097 to 0.127	0.101 units on a scale Interval 0.086 to 0.116
Change From Baseline in EQ-5D-5L at Weeks 16 and 24: EQ-5D Index Week 24	0.053 units on a scale Interval 0.037 to 0.069	0.115 units on a scale Interval 0.099 to 0.131	0.116 units on a scale Interval 0.1 to 0.132

SECONDARY outcome

Timeframe: Weeks 24, 28, 36, 44 and 52

Population: Full analysis set 2 (FAS2) included all randomized participants who were still on study treatment at Week 24. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

ACR 20 response was defined as >=20% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=20% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=238 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=240 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=234 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved ACR 20 Response at Weeks 24, 28, 36, 44 and 52 Week 24	34.0 percentage of participants	66.8 percentage of participants	66.2 percentage of participants
Percentage of Participants Who Achieved ACR 20 Response at Weeks 24, 28, 36, 44 and 52 Week 28	48.3 percentage of participants	71.2 percentage of participants	72.0 percentage of participants
Percentage of Participants Who Achieved ACR 20 Response at Weeks 24, 28, 36, 44 and 52 Week 36	68.8 percentage of participants	77.7 percentage of participants	78.7 percentage of participants
Percentage of Participants Who Achieved ACR 20 Response at Weeks 24, 28, 36, 44 and 52 Week 44	69.7 percentage of participants	79.7 percentage of participants	76.7 percentage of participants
Percentage of Participants Who Achieved ACR 20 Response at Weeks 24, 28, 36, 44 and 52 Week 52	68.7 percentage of participants	79.1 percentage of participants	75.9 percentage of participants

SECONDARY outcome

Timeframe: Weeks 24, 28, 36, 44 and 52

Population: Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

ACR 50 response was defined as >=50% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=50% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=238 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=240 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=234 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved ACR 50 Response at Weeks 24, 28, 36, 44 and 52 Week 24	15.2 percentage of participants	32.8 percentage of participants	34.3 percentage of participants
Percentage of Participants Who Achieved ACR 50 Response at Weeks 24, 28, 36, 44 and 52 Week 28	22.7 percentage of participants	41.4 percentage of participants	40.5 percentage of participants
Percentage of Participants Who Achieved ACR 50 Response at Weeks 24, 28, 36, 44 and 52 Week 36	39.3 percentage of participants	44.1 percentage of participants	45.7 percentage of participants
Percentage of Participants Who Achieved ACR 50 Response at Weeks 24, 28, 36, 44 and 52 Week 44	43.8 percentage of participants	48.3 percentage of participants	48.7 percentage of participants
Percentage of Participants Who Achieved ACR 50 Response at Weeks 24, 28, 36, 44 and 52 Week 52	43.7 percentage of participants	51.3 percentage of participants	49.1 percentage of participants

SECONDARY outcome

Timeframe: Weeks 24, 28, 36, 44 and 52

Population: Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

ACR 70 response was defined as >=70% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=70% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=238 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=240 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=234 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved ACR 70 Response at Weeks 24, 28, 36, 44 and 52 Week 24	4.6 percentage of participants	19.3 percentage of participants	13.7 percentage of participants
Percentage of Participants Who Achieved ACR 70 Response at Weeks 24, 28, 36, 44 and 52 Week 28	7.6 percentage of participants	21.1 percentage of participants	21.1 percentage of participants
Percentage of Participants Who Achieved ACR 70 Response at Weeks 24, 28, 36, 44 and 52 Week 36	15.4 percentage of participants	27.3 percentage of participants	24.7 percentage of participants
Percentage of Participants Who Achieved ACR 70 Response at Weeks 24, 28, 36, 44 and 52 Week 44	20.9 percentage of participants	29.9 percentage of participants	24.4 percentage of participants
Percentage of Participants Who Achieved ACR 70 Response at Weeks 24, 28, 36, 44 and 52 Week 52	19.2 percentage of participants	29.5 percentage of participants	28.1 percentage of participants

SECONDARY outcome

Timeframe: Weeks 24, 28, 36, 44 and 52

Population: Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

ACR components include swollen joint count (66 joints), tender joint count (68 joints), patient's assessment of pain using visual analog scale (VAS; 0-10 cm, 0=no pain and 10=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-10 cm, 0=excellent and 10= poor), physician's global assessment of disease activity (VAS; 0-10 cm, 0=no arthritis activity and 10=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP (mg/dL).

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=238 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=240 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=234 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
ACR Components at Weeks 24, 28, 36, 44 and 52 Week 24: HAQ-DI score	1.1350 units on a scale Standard Deviation 0.61984	0.8766 units on a scale Standard Deviation 0.59893	0.8194 units on a scale Standard Deviation 0.57287
ACR Components at Weeks 24, 28, 36, 44 and 52 Week 24: Swollen Joint Count	5.8 units on a scale Standard Deviation 6.99	3.4 units on a scale Standard Deviation 5.19	4.1 units on a scale Standard Deviation 5.77
ACR Components at Weeks 24, 28, 36, 44 and 52 Week 28: Swollen Joint Count	4.1 units on a scale Standard Deviation 5.17	2.9 units on a scale Standard Deviation 4.95	3.2 units on a scale Standard Deviation 5.53
ACR Components at Weeks 24, 28, 36, 44 and 52 Week 36: Swollen Joint Count	2.5 units on a scale Standard Deviation 3.77	2.4 units on a scale Standard Deviation 4.58	2.7 units on a scale Standard Deviation 4.67
ACR Components at Weeks 24, 28, 36, 44 and 52 Week 44: Swollen Joint Count	2.1 units on a scale Standard Deviation 3.19	2.3 units on a scale Standard Deviation 4.42	2.8 units on a scale Standard Deviation 5.65
ACR Components at Weeks 24, 28, 36, 44 and 52 Week 52: Swollen Joint Count	2.1 units on a scale Standard Deviation 3.59	2.1 units on a scale Standard Deviation 4.16	2.5 units on a scale Standard Deviation 4.83
ACR Components at Weeks 24, 28, 36, 44 and 52 Week 24: Tender Joint Count	14.4 units on a scale Standard Deviation 13.16	9.1 units on a scale Standard Deviation 9.94	10.5 units on a scale Standard Deviation 11.82
ACR Components at Weeks 24, 28, 36, 44 and 52 Week 28: Tender Joint Count	11.7 units on a scale Standard Deviation 11.87	7.9 units on a scale Standard Deviation 9.02	8.6 units on a scale Standard Deviation 10.03
ACR Components at Weeks 24, 28, 36, 44 and 52 Week 36: Tender Joint Count	8.5 units on a scale Standard Deviation 10.00	7.0 units on a scale Standard Deviation 8.72	7.5 units on a scale Standard Deviation 9.25
ACR Components at Weeks 24, 28, 36, 44 and 52 Week 44: Tender Joint Count	7.5 units on a scale Standard Deviation 9.42	6.3 units on a scale Standard Deviation 8.45	7.0 units on a scale Standard Deviation 9.42
ACR Components at Weeks 24, 28, 36, 44 and 52 Week 52: Tender Joint Count	7.4 units on a scale Standard Deviation 10.24	6.2 units on a scale Standard Deviation 8.18	7.3 units on a scale Standard Deviation 9.46
ACR Components at Weeks 24, 28, 36, 44 and 52 Week 24: Patient's Assessment of Pain	5.21 units on a scale Standard Deviation 2.368	3.77 units on a scale Standard Deviation 2.457	3.70 units on a scale Standard Deviation 2.193
ACR Components at Weeks 24, 28, 36, 44 and 52 Week 28: Patient's Assessment of Pain	4.66 units on a scale Standard Deviation 2.341	3.50 units on a scale Standard Deviation 2.311	3.45 units on a scale Standard Deviation 2.259
ACR Components at Weeks 24, 28, 36, 44 and 52 Week 36: Patient's Assessment of Pain	3.78 units on a scale Standard Deviation 2.297	3.28 units on a scale Standard Deviation 2.336	3.20 units on a scale Standard Deviation 2.242
ACR Components at Weeks 24, 28, 36, 44 and 52 Week 44: Patient's Assessment of Pain	3.67 units on a scale Standard Deviation 2.312	3.22 units on a scale Standard Deviation 2.370	3.24 units on a scale Standard Deviation 2.277
ACR Components at Weeks 24, 28, 36, 44 and 52 Week 52: Patient's Assessment of Pain	3.53 units on a scale Standard Deviation 2.253	3.10 units on a scale Standard Deviation 2.333	3.21 units on a scale Standard Deviation 2.371
ACR Components at Weeks 24, 28, 36, 44 and 52 Week 24: PtGA of Disease Activity	5.29 units on a scale Standard Deviation 2.367	4.01 units on a scale Standard Deviation 2.516	3.93 units on a scale Standard Deviation 2.276
ACR Components at Weeks 24, 28, 36, 44 and 52 Week 28: PtGA of Disease Activity	4.75 units on a scale Standard Deviation 2.338	3.76 units on a scale Standard Deviation 2.348	3.62 units on a scale Standard Deviation 2.275
ACR Components at Weeks 24, 28, 36, 44 and 52 Week 36: PtGA of Disease Activity	3.84 units on a scale Standard Deviation 2.295	3.52 units on a scale Standard Deviation 2.390	3.30 units on a scale Standard Deviation 2.318
ACR Components at Weeks 24, 28, 36, 44 and 52 Week 44: PtGA of Disease Activity	3.78 units on a scale Standard Deviation 2.378	3.36 units on a scale Standard Deviation 2.447	3.50 units on a scale Standard Deviation 2.323
ACR Components at Weeks 24, 28, 36, 44 and 52 Week 52: PtGA of Disease Activity	3.68 units on a scale Standard Deviation 2.318	3.23 units on a scale Standard Deviation 2.383	3.28 units on a scale Standard Deviation 2.354
ACR Components at Weeks 24, 28, 36, 44 and 52 Week 24: PGA of Disease Activity	4.22 units on a scale Standard Deviation 2.342	2.74 units on a scale Standard Deviation 2.113	2.66 units on a scale Standard Deviation 1.906
ACR Components at Weeks 24, 28, 36, 44 and 52 Week 28: PGA of Disease Activity	3.27 units on a scale Standard Deviation 1.930	2.44 units on a scale Standard Deviation 1.941	2.33 units on a scale Standard Deviation 1.668
ACR Components at Weeks 24, 28, 36, 44 and 52 Week 36: PGA of Disease Activity	2.28 units on a scale Standard Deviation 1.594	2.10 units on a scale Standard Deviation 1.777	2.06 units on a scale Standard Deviation 1.716
ACR Components at Weeks 24, 28, 36, 44 and 52 Week 44: PGA of Disease Activity	2.06 units on a scale Standard Deviation 1.649	1.97 units on a scale Standard Deviation 1.842	1.93 units on a scale Standard Deviation 1.631
ACR Components at Weeks 24, 28, 36, 44 and 52 Week 52: PGA of Disease Activity	1.90 units on a scale Standard Deviation 1.654	1.77 units on a scale Standard Deviation 1.645	1.77 units on a scale Standard Deviation 1.616
ACR Components at Weeks 24, 28, 36, 44 and 52 Week 28: HAQ-DI score	1.0457 units on a scale Standard Deviation 0.59051	0.8497 units on a scale Standard Deviation 0.61863	0.7985 units on a scale Standard Deviation 0.56677
ACR Components at Weeks 24, 28, 36, 44 and 52 Week 36: HAQ-DI score	0.9621 units on a scale Standard Deviation 0.60695	0.8091 units on a scale Standard Deviation 0.61588	0.7376 units on a scale Standard Deviation 0.56257
ACR Components at Weeks 24, 28, 36, 44 and 52 Week 44: HAQ-DI score	0.9117 units on a scale Standard Deviation 0.63353	0.7927 units on a scale Standard Deviation 0.59979	0.7804 units on a scale Standard Deviation 0.57721
ACR Components at Weeks 24, 28, 36, 44 and 52 Week 52: HAQ-DI score	0.9069 units on a scale Standard Deviation 0.63695	0.7917 units on a scale Standard Deviation 0.59527	0.7364 units on a scale Standard Deviation 0.58655
ACR Components at Weeks 24, 28, 36, 44 and 52 Week 24: CRP	1.543 units on a scale Standard Deviation 2.1572	0.961 units on a scale Standard Deviation 1.2868	0.790 units on a scale Standard Deviation 0.8390
ACR Components at Weeks 24, 28, 36, 44 and 52 Week 28: CRP	1.120 units on a scale Standard Deviation 1.5140	0.956 units on a scale Standard Deviation 1.3749	0.885 units on a scale Standard Deviation 1.0299
ACR Components at Weeks 24, 28, 36, 44 and 52 Week 36: CRP	0.920 units on a scale Standard Deviation 1.4674	0.892 units on a scale Standard Deviation 1.3109	0.837 units on a scale Standard Deviation 1.0730
ACR Components at Weeks 24, 28, 36, 44 and 52 Week 44: CRP	0.858 units on a scale Standard Deviation 1.0558	0.812 units on a scale Standard Deviation 1.0139	0.992 units on a scale Standard Deviation 1.9875
ACR Components at Weeks 24, 28, 36, 44 and 52 Week 52: CRP	0.907 units on a scale Standard Deviation 1.5985	0.937 units on a scale Standard Deviation 1.2422	0.910 units on a scale Standard Deviation 1.2756

SECONDARY outcome

Timeframe: Baseline, Weeks 24, 28, 36, 44 and 52

Population: Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

ACR components include swollen joint count (66 joints), tender joint count (68 joints), patient's assessment of pain using visual analog scale (VAS; 0-10 cm, 0=no pain and 10=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-10 cm, 0=excellent and 10= poor), physician's global assessment of disease activity (VAS; 0-10 cm, 0=no arthritis activity and 10=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP (mg/dL).

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=238 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=240 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=234 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 44: CRP	-1.262 units on a scale Standard Deviation 2.5377	-1.145 units on a scale Standard Deviation 2.1378	-0.861 units on a scale Standard Deviation 2.8133
Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 52: CRP	-1.237 units on a scale Standard Deviation 2.8242	-1.021 units on a scale Standard Deviation 2.2289	-0.937 units on a scale Standard Deviation 2.4116
Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 24: Swollen Joint Count	-6.4 units on a scale Standard Deviation 7.25	-8.2 units on a scale Standard Deviation 6.09	-8.8 units on a scale Standard Deviation 5.50
Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 28: Swollen Joint Count	-8.1 units on a scale Standard Deviation 6.99	-8.8 units on a scale Standard Deviation 5.98	-9.6 units on a scale Standard Deviation 6.65
Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 36: Swollen Joint Count	-9.9 units on a scale Standard Deviation 6.47	-9.2 units on a scale Standard Deviation 5.81	-10.2 units on a scale Standard Deviation 6.76
Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 44: Swollen Joint Count	-10.1 units on a scale Standard Deviation 6.77	-9.3 units on a scale Standard Deviation 6.24	-10.2 units on a scale Standard Deviation 6.28
Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 52: Swollen Joint Count	-10.2 units on a scale Standard Deviation 6.79	-9.6 units on a scale Standard Deviation 6.28	-10.4 units on a scale Standard Deviation 6.17
Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 24: Tender Joint Count	-7.0 units on a scale Standard Deviation 10.91	-10.4 units on a scale Standard Deviation 9.51	-11.9 units on a scale Standard Deviation 9.98
Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 28: Tender Joint Count	-9.7 units on a scale Standard Deviation 10.78	-11.7 units on a scale Standard Deviation 9.24	-13.7 units on a scale Standard Deviation 10.53
Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 36: Tender Joint Count	-13.2 units on a scale Standard Deviation 10.78	-12.5 units on a scale Standard Deviation 9.68	-14.6 units on a scale Standard Deviation 10.31
Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 44: Tender Joint Count	-14.0 units on a scale Standard Deviation 11.02	-13.3 units on a scale Standard Deviation 9.56	-15.2 units on a scale Standard Deviation 10.25
Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 52: Tender Joint Count	-14.1 units on a scale Standard Deviation 11.39	-13.4 units on a scale Standard Deviation 10.03	-15.0 units on a scale Standard Deviation 10.51
Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 24: Patient's Assessment of Pain	-1.08 units on a scale Standard Deviation 2.441	-2.55 units on a scale Standard Deviation 2.477	-2.41 units on a scale Standard Deviation 2.335
Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 28: Patient's Assessment of Pain	-1.63 units on a scale Standard Deviation 2.420	-2.83 units on a scale Standard Deviation 2.519	-2.66 units on a scale Standard Deviation 2.416
Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 36: Patient's Assessment of Pain	-2.51 units on a scale Standard Deviation 2.588	-3.02 units on a scale Standard Deviation 2.534	-2.89 units on a scale Standard Deviation 2.540
Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 44: Patient's Assessment of Pain	-2.62 units on a scale Standard Deviation 2.640	-3.07 units on a scale Standard Deviation 2.644	-2.87 units on a scale Standard Deviation 2.601
Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 52: Patient's Assessment of Pain	-2.75 units on a scale Standard Deviation 2.659	-3.20 units on a scale Standard Deviation 2.555	-2.89 units on a scale Standard Deviation 2.681
Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 24: PtGA of Disease Activity	-1.25 units on a scale Standard Deviation 2.601	-2.52 units on a scale Standard Deviation 2.490	-2.40 units on a scale Standard Deviation 2.383
Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 28: PtGA of Disease Activity	-1.79 units on a scale Standard Deviation 2.543	-2.79 units on a scale Standard Deviation 2.560	-2.70 units on a scale Standard Deviation 2.382
Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 36: PtGA of Disease Activity	-2.70 units on a scale Standard Deviation 2.555	-2.99 units on a scale Standard Deviation 2.569	-3.01 units on a scale Standard Deviation 2.445
Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 44: PtGA of Disease Activity	-2.76 units on a scale Standard Deviation 2.741	-3.15 units on a scale Standard Deviation 2.650	-2.86 units on a scale Standard Deviation 2.559
Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 52: PtGA of Disease Activity	-2.85 units on a scale Standard Deviation 2.757	-3.29 units on a scale Standard Deviation 2.558	-3.06 units on a scale Standard Deviation 2.527
Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 24: PGA of Disease Activity	-2.45 units on a scale Standard Deviation 2.248	-3.84 units on a scale Standard Deviation 2.316	-3.93 units on a scale Standard Deviation 2.227
Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 28: PGA of Disease Activity	-3.42 units on a scale Standard Deviation 2.189	-4.16 units on a scale Standard Deviation 2.175	-4.28 units on a scale Standard Deviation 2.054
Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 36: PGA of Disease Activity	-4.39 units on a scale Standard Deviation 2.052	-4.49 units on a scale Standard Deviation 2.116	-4.53 units on a scale Standard Deviation 2.173
Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 44: PGA of Disease Activity	-4.61 units on a scale Standard Deviation 2.043	-4.55 units on a scale Standard Deviation 2.139	-4.70 units on a scale Standard Deviation 2.084
Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 52: PGA of Disease Activity	-4.77 units on a scale Standard Deviation 2.007	-4.78 units on a scale Standard Deviation 1.996	-4.81 units on a scale Standard Deviation 2.120
Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 24: HAQ-DI score	-0.1646 units on a scale Standard Deviation 0.53253	-0.4044 units on a scale Standard Deviation 0.54194	-0.4257 units on a scale Standard Deviation 0.50337
Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 28: HAQ-DI score	-0.2547 units on a scale Standard Deviation 0.50426	-0.4383 units on a scale Standard Deviation 0.55648	-0.4429 units on a scale Standard Deviation 0.51556
Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 36: HAQ-DI score	-0.3423 units on a scale Standard Deviation 0.52951	-0.4702 units on a scale Standard Deviation 0.55698	-0.5000 units on a scale Standard Deviation 0.55438
Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 44: HAQ-DI score	-0.3868 units on a scale Standard Deviation 0.57065	-0.4824 units on a scale Standard Deviation 0.57091	-0.4652 units on a scale Standard Deviation 0.56121
Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 52: HAQ-DI score	-0.3848 units on a scale Standard Deviation 0.58049	-0.4824 units on a scale Standard Deviation 0.56167	-0.5082 units on a scale Standard Deviation 0.58255
Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 24: CRP	-0.547 units on a scale Standard Deviation 2.5657	-1.038 units on a scale Standard Deviation 2.0932	-1.052 units on a scale Standard Deviation 2.1295
Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 28: CRP	-0.993 units on a scale Standard Deviation 2.3669	-1.028 units on a scale Standard Deviation 2.0476	-0.976 units on a scale Standard Deviation 2.1663
Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 36: CRP	-1.202 units on a scale Standard Deviation 2.3234	-1.098 units on a scale Standard Deviation 2.1102	-1.020 units on a scale Standard Deviation 2.1985

SECONDARY outcome

Timeframe: Baseline, Weeks 24, 28, 36, 44 and 52

Population: Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

ACR components include swollen joint count (66 joints), tender joint count (68 joints), patient's assessment of pain using visual analog scale (VAS; 0-10 cm, 0=no pain and 10=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-10 cm, 0=excellent and 10= poor), physician's global assessment of disease activity (VAS; 0-10 cm, 0=no arthritis activity and 10=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP (mg/dL).

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=238 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=240 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=234 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 44: PtGA of Disease Activity	-38.45 percent change Standard Deviation 43.993	-46.64 percent change Standard Deviation 38.228	-42.45 percent change Standard Deviation 39.243
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 52: PtGA of Disease Activity	-39.34 percent change Standard Deviation 44.933	-48.73 percent change Standard Deviation 38.925	-45.50 percent change Standard Deviation 40.653
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 24: PGA of Disease Activity	-36.13 percent change Standard Deviation 33.383	-57.60 percent change Standard Deviation 32.634	-59.06 percent change Standard Deviation 28.137
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 24: Swollen Joint Count	-53.44 percent change Standard Deviation 45.655	-72.06 percent change Standard Deviation 33.971	-73.17 percent change Standard Deviation 30.614
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 28: Swollen Joint Count	-66.15 percent change Standard Deviation 37.305	-78.02 percent change Standard Deviation 30.197	-78.85 percent change Standard Deviation 28.109
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 36: Swollen Joint Count	-80.38 percent change Standard Deviation 28.144	-82.82 percent change Standard Deviation 26.054	-81.49 percent change Standard Deviation 27.338
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 44: Swollen Joint Count	-81.85 percent change Standard Deviation 26.328	-82.10 percent change Standard Deviation 27.742	-83.32 percent change Standard Deviation 24.289
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 52: Swollen Joint Count	-82.34 percent change Standard Deviation 30.494	-83.18 percent change Standard Deviation 30.121	-84.07 percent change Standard Deviation 24.070
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 24: Tender Joint Count	-32.53 percent change Standard Deviation 44.850	-54.81 percent change Standard Deviation 37.134	-57.11 percent change Standard Deviation 35.073
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 28: Tender Joint Count	-45.52 percent change Standard Deviation 41.132	-62.48 percent change Standard Deviation 32.820	-64.31 percent change Standard Deviation 31.767
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 36: Tender Joint Count	-62.21 percent change Standard Deviation 34.292	-66.12 percent change Standard Deviation 32.829	-68.50 percent change Standard Deviation 30.000
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 44: Tender Joint Count	-65.88 percent change Standard Deviation 33.344	-70.90 percent change Standard Deviation 29.688	-72.10 percent change Standard Deviation 27.670
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 52: Tender Joint Count	-67.29 percent change Standard Deviation 35.583	-70.29 percent change Standard Deviation 31.985	-69.82 percent change Standard Deviation 32.122
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 24: Patient's Assessment of Pain	-11.52 percent change Standard Deviation 48.647	-38.44 percent change Standard Deviation 40.734	-36.64 percent change Standard Deviation 38.086
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 28: Patient's Assessment of Pain	-22.20 percent change Standard Deviation 42.404	-42.17 percent change Standard Deviation 41.660	-41.02 percent change Standard Deviation 39.624
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 36: Patient's Assessment of Pain	-35.65 percent change Standard Deviation 43.207	-45.89 percent change Standard Deviation 40.125	-43.29 percent change Standard Deviation 44.442
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 44: Patient's Assessment of Pain	-37.45 percent change Standard Deviation 43.534	-46.48 percent change Standard Deviation 41.725	-43.60 percent change Standard Deviation 42.560
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 52: Patient's Assessment of Pain	-38.23 percent change Standard Deviation 47.430	-49.00 percent change Standard Deviation 39.082	-43.51 percent change Standard Deviation 45.742
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 24: PtGA of Disease Activity	-13.78 percent change Standard Deviation 45.943	-37.18 percent change Standard Deviation 38.628	-33.90 percent change Standard Deviation 51.672
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 28: PtGA of Disease Activity	-23.78 percent change Standard Deviation 40.895	-39.92 percent change Standard Deviation 40.228	-40.70 percent change Standard Deviation 36.587
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 36: PtGA of Disease Activity	-38.82 percent change Standard Deviation 37.114	-44.21 percent change Standard Deviation 36.982	-45.52 percent change Standard Deviation 38.659
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 28: PGA of Disease Activity	-49.72 percent change Standard Deviation 30.129	-62.89 percent change Standard Deviation 28.027	-64.14 percent change Standard Deviation 25.784
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 36: PGA of Disease Activity	-64.57 percent change Standard Deviation 25.695	-67.98 percent change Standard Deviation 25.989	-67.74 percent change Standard Deviation 28.029
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 44: PGA of Disease Activity	-68.32 percent change Standard Deviation 25.560	-69.79 percent change Standard Deviation 26.949	-70.27 percent change Standard Deviation 24.516
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 52: PGA of Disease Activity	-71.05 percent change Standard Deviation 25.056	-73.09 percent change Standard Deviation 24.133	-72.46 percent change Standard Deviation 24.485
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 24: HAQ-DI score	-6.86 percent change Standard Deviation 54.753	-25.47 percent change Standard Deviation 63.639	-33.72 percent change Standard Deviation 51.766
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 28: HAQ-DI score	-15.66 percent change Standard Deviation 49.522	-28.82 percent change Standard Deviation 73.930	-33.91 percent change Standard Deviation 59.310
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 36: HAQ-DI score	-23.34 percent change Standard Deviation 46.393	-31.95 percent change Standard Deviation 78.348	-37.74 percent change Standard Deviation 56.329
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 44: HAQ-DI score	-27.01 percent change Standard Deviation 49.683	-33.84 percent change Standard Deviation 60.164	-32.45 percent change Standard Deviation 72.337
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 52: HAQ-DI score	-26.83 percent change Standard Deviation 54.380	-33.49 percent change Standard Deviation 63.823	-35.02 percent change Standard Deviation 65.765
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 24: CRP	19.81 percent change Standard Deviation 150.274	-26.90 percent change Standard Deviation 110.466	-28.35 percent change Standard Deviation 88.038
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 28: CRP	-0.80 percent change Standard Deviation 155.637	-21.09 percent change Standard Deviation 144.287	15.69 percent change Standard Deviation 468.613
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 36: CRP	-6.70 percent change Standard Deviation 183.299	-25.47 percent change Standard Deviation 157.839	-23.97 percent change Standard Deviation 104.641
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 44: CRP	-8.33 percent change Standard Deviation 143.843	-37.54 percent change Standard Deviation 76.302	-17.44 percent change Standard Deviation 127.594
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 52: CRP	-0.25 percent change Standard Deviation 208.267	-23.15 percent change Standard Deviation 104.461	-0.99 percent change Standard Deviation 193.429

SECONDARY outcome

Timeframe: Week 52

Population: FAS2 among participants achieved ACR20 response at Week 24. Here, N (number of participants analyzed) signifies number of participants analyzed for this OM. OM was planned to assess maintenance of guselkumab effect only through Week 52, hence data is reported for guselkumab 100mg q8w and guselkumab 100mg q4w arms only and not for placebo arm.

ACR 20 response was defined as >=20% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=20% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=156 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=151 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Maintained an ACR 20 Response at Week 52 Among Participants Who Achieved an ACR 20 Response at Week 24	91.7 percentage of participants	86.8 percentage of participants	—

SECONDARY outcome

Timeframe: Week 52

Population: FAS2 among participants achieved ACR50 response at Week 24. Here, N (number of participants analyzed) signifies number of participants analyzed for this OM. The OM was planned to assess maintenance of guselkumab effect only through Week 52, hence data is reported for guselkumab 100 mg q8w and guselkumab 100 mg q4w arms only and not for placebo arm.

ACR 50 response was defined as >=50% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=50% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=78 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=77 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Maintained an ACR 50 Response at Week 52 Among Participants Who Achieved an ACR 50 Response at Week 24	87.2 percentage of participants	79.2 percentage of participants	—

SECONDARY outcome

Timeframe: Week 52

Population: Analysis population is FAS2 among participants who achieved ACR 70 response at Week 24. The outcome measure was planned to assess the maintenance of guselkumab effect only through Week 52, hence the data in this outcome measure is reported for guselkumab 100 mg q8w and guselkumab 100 mg q4w arms only and not for placebo arm.

ACR 70 response was defined as >=70% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=70% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 millimeters [mm], 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=46 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=32 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Maintained an ACR 70 Response at Week 52 Among Participants Who Achieved an ACR 70 Response at Week 24	82.6 percentage of participants	75.0 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline, Weeks 24, 28, 36, 44 and 52

Population: Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

HAQ-DI score assess functional status of participant. It is 20 question instrument that assess degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0=indicating no difficulty, to 3=indicating inability to perform a task in that area. Total HAQ score is average of the computed categories scores ranging from 0-3 where 0=least difficulty and 3=extreme difficulty. Lower scores are indicative of better functioning. Negative change from baseline indicates improvement of physical function.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=238 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=240 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=234 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52 Week 24	-0.1646 units on a scale Standard Deviation 0.53253	-0.4044 units on a scale Standard Deviation 0.54194	-0.4257 units on a scale Standard Deviation 0.50337
Change From Baseline in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52 Week 28	-0.2547 units on a scale Standard Deviation 0.50426	-0.4383 units on a scale Standard Deviation 0.55648	-0.4429 units on a scale Standard Deviation 0.51556
Change From Baseline in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52 Week 36	-0.3423 units on a scale Standard Deviation 0.52951	-0.4702 units on a scale Standard Deviation 0.55698	-0.5000 units on a scale Standard Deviation 0.55438
Change From Baseline in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52 Week 44	-0.3868 units on a scale Standard Deviation 0.57065	-0.4824 units on a scale Standard Deviation 0.57091	-0.4652 units on a scale Standard Deviation 0.56121
Change From Baseline in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52 Week 52	-0.3848 units on a scale Standard Deviation 0.58049	-0.4824 units on a scale Standard Deviation 0.56167	-0.5082 units on a scale Standard Deviation 0.58255

SECONDARY outcome

Timeframe: Weeks 24, 28, 36, 44 and 52

Population: Analysis population is FAS2 among participants with HAQ-DI score \>=0.35 at baseline and who achieved a HAQ-DI response at Week 52. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

HAQ-DI score assess functional status of participant. It is 20 question instrument that assess degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0=indicating no difficulty, to 3=indicating inability to perform a task in that area. Total HAQ score is average of the computed categories scores ranging from 0-3 where 0=least difficulty and 3=extreme difficulty. Lower scores are indicative of better functioning and a decrease of 0.35 from baseline in HAQ-DI score indicates a meaningful improvement.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=229 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=221 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=218 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved a Clinically Meaningful Improvement (>=0.35 Improvement From Baseline) in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52 Among Participants With HAQ-DI Score >=0.35 at Baseline Week 24	34.1 percentage of participants	52.5 percentage of participants	58.3 percentage of participants
Percentage of Participants Who Achieved a Clinically Meaningful Improvement (>=0.35 Improvement From Baseline) in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52 Among Participants With HAQ-DI Score >=0.35 at Baseline Week 28	42.4 percentage of participants	58.4 percentage of participants	63.4 percentage of participants
Percentage of Participants Who Achieved a Clinically Meaningful Improvement (>=0.35 Improvement From Baseline) in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52 Among Participants With HAQ-DI Score >=0.35 at Baseline Week 36	48.4 percentage of participants	58.2 percentage of participants	61.9 percentage of participants
Percentage of Participants Who Achieved a Clinically Meaningful Improvement (>=0.35 Improvement From Baseline) in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52 Among Participants With HAQ-DI Score >=0.35 at Baseline Week 44	50.9 percentage of participants	60.0 percentage of participants	61.4 percentage of participants
Percentage of Participants Who Achieved a Clinically Meaningful Improvement (>=0.35 Improvement From Baseline) in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52 Among Participants With HAQ-DI Score >=0.35 at Baseline Week 52	50.5 percentage of participants	60.9 percentage of participants	62.9 percentage of participants

SECONDARY outcome

Timeframe: Week 52

Population: Analysis population is FAS2 among participants who achieved a HAQ-DI response at Week 24. The OM was planned to assess the maintenance of guselkumab effect only through Week 52, hence the data in this outcome measure is reported for guselkumab 100 mg q8w and guselkumab 100 mg q4w arms only and not for placebo arm.

HAQ-DI score assess functional status of participant. It is 20 question instrument that assess degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0=indicating no difficulty, to 3=indicating inability to perform a task in that area. Total HAQ score is average of the computed categories scores ranging from 0-3 where 0=least difficulty and 3=extreme difficulty. Lower scores are indicative of better functioning and a decrease of 0.35 from baseline in HAQ-DI score indicates a meaningful improvement.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=112 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=123 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Maintained a HAQ-DI Response (>=0.35 Improvement From Baseline in HAQ-DI Score) at Week 52 Among Participants Who Achieved a HAQ-DI Response at Week 24	92.0 percentage of participants	88.6 percentage of participants	—

SECONDARY outcome

Timeframe: Weeks 24, 28, 36, 44 and 52

Population: Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

DAS28 based on CRP is an index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. DAS28 (CRP) response criteria was defined as follows: Good response: <=3.2 at visit and >1.2 improvement; Moderate response: >3.2 at visit and >1.2 improvement or <=5.1 at visit and >0.6-1.2 improvement; No response: <=0.6 improvement, or >5.1 at visit and <=1.2 improvement. The values are 0=best to 10=worst. A DAS28 (CRP) responder was defined as achieving a good or moderate DAS28 response at a specific visit.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=238 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=240 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=234 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 24, 28, 36, 44 and 52 Week 24	55.5 percentage of participants	79.0 percentage of participants	83.8 percentage of participants
Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 24, 28, 36, 44 and 52 Week 28	72.3 percentage of participants	85.0 percentage of participants	85.9 percentage of participants
Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 24, 28, 36, 44 and 52 Week 36	86.5 percentage of participants	86.9 percentage of participants	92.5 percentage of participants
Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 24, 28, 36, 44 and 52 Week 44	91.0 percentage of participants	91.8 percentage of participants	91.9 percentage of participants
Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 24, 28, 36, 44 and 52 Week 52	89.0 percentage of participants	89.7 percentage of participants	89.4 percentage of participants

SECONDARY outcome

Timeframe: Weeks 24, 28, 36, 44 and 52

Population: Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

DAS28 based on CRP is an index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. DAS28 (CRP) remission was defined as DAS28 (CRP) value <2.6 at the analysis visit.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=238 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=240 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=234 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 24, 28, 36, 44 and 52 Week 24	9.3 percentage of participants	25.6 percentage of participants	24.4 percentage of participants
Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 24, 28, 36, 44 and 52 Week 28	13.2 percentage of participants	27.5 percentage of participants	30.4 percentage of participants
Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 24, 28, 36, 44 and 52 Week 36	25.7 percentage of participants	36.0 percentage of participants	39.5 percentage of participants
Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 24, 28, 36, 44 and 52 Week 44	30.0 percentage of participants	38.4 percentage of participants	38.0 percentage of participants
Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 24, 28, 36, 44 and 52 Week 52	34.2 percentage of participants	39.7 percentage of participants	39.6 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 24, 28, 36, 44 and 52

Population: Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

DAS28 based on CRP is an index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. Negative changes from baseline indicate improvement of arthritis.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=238 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=240 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=234 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in DAS28 (CRP) Score at Weeks 24, 28, 36, 44 and 52 Week 28	-1.38 units on a scale Standard Deviation 1.099	-1.78 units on a scale Standard Deviation 1.038	-1.86 units on a scale Standard Deviation 1.066
Change From Baseline in DAS28 (CRP) Score at Weeks 24, 28, 36, 44 and 52 Week 24	-1.02 units on a scale Standard Deviation 1.101	-1.63 units on a scale Standard Deviation 1.051	-1.68 units on a scale Standard Deviation 0.976
Change From Baseline in DAS28 (CRP) Score at Weeks 24, 28, 36, 44 and 52 Week 36	-1.92 units on a scale Standard Deviation 1.086	-1.97 units on a scale Standard Deviation 1.114	-2.08 units on a scale Standard Deviation 1.088
Change From Baseline in DAS28 (CRP) Score at Weeks 24, 28, 36, 44 and 52 Week 44	-2.04 units on a scale Standard Deviation 1.098	-2.09 units on a scale Standard Deviation 1.107	-2.08 units on a scale Standard Deviation 1.063
Change From Baseline in DAS28 (CRP) Score at Weeks 24, 28, 36, 44 and 52 Week 52	-2.14 units on a scale Standard Deviation 1.142	-2.08 units on a scale Standard Deviation 1.121	-2.11 units on a scale Standard Deviation 1.128

SECONDARY outcome

Timeframe: Weeks 24, 28, 36, 44 and 52

Population: Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

The modified PsARC response was defined as improvement in at least 2 of the four criteria: >=30% decrease in swollen joint count, >=30% decrease in tender joint count, >=20% improvement in patient's Global Assessment of Disease Activity (arthritis) on a VAS (0-100 mm, 0=excellent and 100= poor), >=20% improvement in physician's Global Assessment of Disease Activity using VAS (VAS: 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), and at least one of the 2 joint criteria with no deterioration in the other criteria.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=238 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=240 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=234 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 24, 28, 36, 44 and 52 Week 24	46.6 percentage of participants	76.4 percentage of participants	72.8 percentage of participants
Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 24, 28, 36, 44 and 52 Week 28	64.6 percentage of participants	79.3 percentage of participants	83.1 percentage of participants
Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 24, 28, 36, 44 and 52 Week 36	78.7 percentage of participants	82.3 percentage of participants	84.3 percentage of participants
Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 24, 28, 36, 44 and 52 Week 44	77.6 percentage of participants	83.7 percentage of participants	82.2 percentage of participants
Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 24, 28, 36, 44 and 52 Week 52	81.2 percentage of participants	86.3 percentage of participants	82.9 percentage of participants

SECONDARY outcome

Timeframe: Weeks 24 and 52

Population: Analysis population is FAS2 among the participants with enthesitis (LEI) at baseline. Here, n (number analyzed) signifies the number of participants evaluable for enthesitis resolution at specified timepoints.

Enthesitis was assessed using the LEI, a tool developed to assess enthesitis in participants with PsA and evaluates the presence (score of 1) or absence (score of 0) of pain by applying local pressure to the following entheses: left and right lateral epicondyle humerus, left and right medial femoral condyle, and left and right achilles tendon insertion. The enthesitis index score is a total score of the 6 evaluated sites from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). A LEI score of 0 at a post baseline visit indicates resolution of enthesitis when baseline LEI>0.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=172 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=152 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=165 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants With Resolution of Enthesitis at Weeks 24 and 52 Among the Participants With Enthesitis at Baseline Week 24	32.6 percentage of participants	57.6 percentage of participants	45.5 percentage of participants
Percentage of Participants With Resolution of Enthesitis at Weeks 24 and 52 Among the Participants With Enthesitis at Baseline Week 52	67.3 percentage of participants	65.5 percentage of participants	60.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 24 and 52

Population: Analysis population is FAS2 among the participants with enthesitis (LEI) at baseline. Here n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Enthesitis was assessed using the LEI, a tool developed to assess enthesitis in participants with PsA and evaluates the presence (score of 1) or absence (score of 0) of pain by applying local pressure to the following entheses: left and right lateral epicondyle humerus, left and right medial femoral condyle, and left and right achilles tendon insertion. The enthesitis index score is a total score of the 6 evaluated sites from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). Negative changes from baseline indicate improvement of enthesitis.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=172 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=152 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=165 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 24 and 52 Among the Participants With Enthesitis at Baseline Week 24	-1.1 units on a scale Standard Deviation 1.66	-1.6 units on a scale Standard Deviation 1.75	-1.6 units on a scale Standard Deviation 1.63
Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 24 and 52 Among the Participants With Enthesitis at Baseline Week 52	-2.1 units on a scale Standard Deviation 1.61	-1.9 units on a scale Standard Deviation 1.65	-2.0 units on a scale Standard Deviation 1.78

SECONDARY outcome

Timeframe: Weeks 24 and 52

Population: Analysis population is FAS2 among the participants with dactylitis at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

The presence and severity of dactylitis was assessed in both hands and feet using a scoring system from 0 to 3 (0-no dactylitis, 1-mild dactylitis, 2-moderate dactylitis, and 3-severe dactylitis) for each digit. The results were summed to produce a final score ranging from 0 to 60. Higher score indicates more severe dactylitis. Resolution of dactylitis was defined as a dactylitis score of 0 with the baseline dactylitis score >0.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=95 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=108 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=116 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants With Resolution of Dactylitis at Weeks 24 and 52 Among Participants With Dactylitis at Baseline Week 24	41.1 percentage of participants	60.7 percentage of participants	68.1 percentage of participants
Percentage of Participants With Resolution of Dactylitis at Weeks 24 and 52 Among Participants With Dactylitis at Baseline Week 52	78.5 percentage of participants	81.9 percentage of participants	81.1 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 24 and 52

Population: Analysis population is FAS2 among the participants with dactylitis at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

The presence and severity of dactylitis was assessed in both hands and feet using a scoring system from 0 to 3 (0-no dactylitis, 1-mild dactylitis, 2-moderate dactylitis, and 3-severe dactylitis) for each digit. The results were summed to produce a final score ranging from 0 to 60. A higher score indicates more severe dactylitis. Negative changes from baseline indicate improvement in dactylitis.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=95 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=108 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=116 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in Dactylitis Score at Weeks 24 and 52 Among the Participants With Dactylitis at Baseline Week 24	-4.6 units on a scale Standard Deviation 7.88	-6.1 units on a scale Standard Deviation 7.83	-6.6 units on a scale Standard Deviation 7.84
Change From Baseline in Dactylitis Score at Weeks 24 and 52 Among the Participants With Dactylitis at Baseline Week 52	-7.4 units on a scale Standard Deviation 9.18	-7.3 units on a scale Standard Deviation 9.74	-7.4 units on a scale Standard Deviation 8.59

SECONDARY outcome

Timeframe: Baseline, Weeks 24 and 52

Population: Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

PASDAS (score range of 0 to 10, where higher score indicated more severe disease) is a composite score of overall disease activity combining Patient's Global Assessment of Disease Activity (arthritis and psoriasis, using VAS [0-100 mm, 0=excellent and 100= poor), Physician's Global Assessment of Disease Activity (using VAS [0-100 mm, 0=no arthritis activity and 100=extremely active arthritis]), swollen joint count (0-66 joints), tender joint count (0-68 joints), CRP (mg/L), enthesitis based on LEI (0= 0 sites with tenderness to 6= worst possible score; 6 sites with tenderness), tender dactylitis count (scoring each digit from 0-3 [where 0= no tenderness and 3= extreme tenderness] and recoding to 0-1, where any score > 0 equaled 1), and the PCS score with score range 0-100 (higher score-better quality of life) of the SF-36 health survey. The cutoffs for disease activity were 3.2 (low) to 5.4 (high). Negative changes from baseline indicate improvement of overall disease activity.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=238 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=240 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=234 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in Psoriatic Arthritis Disease Activity (PASDAS) Score at Weeks 24 and 52 Week 24	-1.399 units on a scale Standard Deviation 1.3169	-2.496 units on a scale Standard Deviation 1.5024	-2.506 units on a scale Standard Deviation 1.2578
Change From Baseline in Psoriatic Arthritis Disease Activity (PASDAS) Score at Weeks 24 and 52 Week 52	-3.041 units on a scale Standard Deviation 1.4979	-3.197 units on a scale Standard Deviation 1.5212	-3.161 units on a scale Standard Deviation 1.4646

SECONDARY outcome

Timeframe: Weeks 24 and 52

Population: Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

PASDAS (score range of 0 to 10, where higher score indicated more severe disease) is a composite score of overall disease activity combining Patient's Global Assessment of Disease Activity (arthritis and psoriasis, using VAS [0-100 mm, 0=excellent and 100= poor), Physician's Global Assessment of Disease Activity (using VAS [0-100 mm, 0=no arthritis activity and 100=extremely active arthritis]), swollen joint count (0-66 joints), tender joint count (0-68 joints), CRP (mg/L), enthesitis based on LEI (0= 0 sites with tenderness to 6= worst possible score; 6 sites with tenderness), tender dactylitis count (scoring each digit from 0-3 [where 0= no tenderness and 3= extreme tenderness] and recoding to 0-1, where any score > 0 equaled 1), and the PCS score with score range 0-100 (higher score-better quality of life) of the SF-36 health survey. The cutoffs for disease activity were 3.2 (low) to 5.4 (high). Negative changes from baseline indicate improvement of overall disease activity.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=238 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=240 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=234 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants With Low or Very Low Disease Activity Based on Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 24 and 52 Week 24	8.1 percentage of participants	31.6 percentage of participants	24.6 percentage of participants
Percentage of Participants With Low or Very Low Disease Activity Based on Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 24 and 52 Week 52	38.5 percentage of participants	45.3 percentage of participants	46.3 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 24 and 52

Population: Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

GRACE index is a composite PsA disease activity score converted from AMDF, which was derived from TJC (0-68) and SJC (0-66), HAQ-DI (0-3), patient's global assessment of disease activity on arthritis and psoriasis (0-100 mm, 0=excellent and 100= poor), patient's assessment of skin disease activity (0-100 mm, 0=excellent and 100=poor), patient's global assessment of disease activity on arthritis (0-100 mm, 0=excellent and 100=poor), PASI (0-72), and PsA Quality of Life Index (derived as PsAQOL =25.355 + [2.367*HAQ-DI] - [0.234*SF-PCS] - [0.244*SF-MCS]), where HAQ-DI: HAQ-DI score (0-3, 0=least difficulty and 3=extreme difficulty), SF-PCS (Score ranges from 0 to 100, higher scores= better quality of life) and SF-MCS (score ranges from 0 to 100, higher scores= better quality of life). The total score is from 0-10, where lower score indicates better response. Higher score indicates more active disease activity. Negative change from baseline indicates improvement of PsA disease activity.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=238 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=240 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=234 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score Index at Weeks 24 and 52 Week 24	-1.260 units on a scale Standard Deviation 1.4909	-2.658 units on a scale Standard Deviation 1.6770	-2.672 units on a scale Standard Deviation 1.4589
Change From Baseline in Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score Index at Weeks 24 and 52 Week 52	-3.085 units on a scale Standard Deviation 1.6277	-3.271 units on a scale Standard Deviation 1.6453	-3.267 units on a scale Standard Deviation 1.5646

SECONDARY outcome

Timeframe: Weeks 24 and 52

Population: Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

GRACE index is a composite PsA disease activity score converted from Arithmetic Mean of Desirability Function (AMDF), derived from TJC (0-68) and SJC (0-66), HAQ-DI (0-3), PtGA of disease activity on arthritis and psoriasis (0-100 mm, 0=excellent and 100=poor), patient's assessment of skin disease activity (0-100 mm, 0=excellent and 100=poor), PtGA of disease activity on arthritis (0-100 mm, 0=excellent and 100=poor), PASI (0-72), and PsA Quality of Life Index (derived as PsAQOL=25.355 + [2.367*HAQ-DI]-[0.234*SF-PCS]-[0.244*SF-MCS]), where HAQ-DI: HAQ-DI score (0-3, 0=least difficulty and 3=extreme difficulty), SF-PCS (Score range= 0-100, higher scores= better quality of life) and SF-MCS (score range=0-100, higher scores= better quality of life). Total score is 0-10, lower score=better response. Higher score= more active disease activity. Negative change from baseline indicates improvement of PsA disease activity. GRACE low disease activity is GRACE score <=2.3 at the analysis visit.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=238 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=240 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=234 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants With Low Disease Activity Based on Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score Index at Weeks 24 and 52 Week 24	7.6 percentage of participants	29.5 percentage of participants	27.6 percentage of participants
Percentage of Participants With Low Disease Activity Based on Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score Index at Weeks 24 and 52 Week 52	34.9 percentage of participants	43.2 percentage of participants	43.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 24, 28, 36, 44 and 52

Population: Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

DAPSA assessed the joint domain of PsA and was derived from the sum of the following components: tender joint count (0-68), swollen joint count (0-66), CRP level (mg/dL), patient assessment of pain (0-10cm VAS, 0=no pain, 10=worst possible pain), and patient's global assessment of disease activity on arthritis (0 to 10cm VAS, 0=excellent and 10=poor). A higher score indicates more active disease activity. Negative changes from baseline indicate improvement of PsA disease activity. The assessment does not have a score range with an upper or lower bound.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=238 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=240 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=234 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 24, 28, 36, 44 and 52 Week 24	-16.377 units on a scale Standard Deviation 19.1814	-24.718 units on a scale Standard Deviation 16.7967	-26.578 units on a scale Standard Deviation 15.3393
Change From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 24, 28, 36, 44 and 52 Week 28	-22.199 units on a scale Standard Deviation 17.9394	-26.573 units on a scale Standard Deviation 15.5254	-29.613 units on a scale Standard Deviation 17.6129
Change From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 24, 28, 36, 44 and 52 Week 36	-29.251 units on a scale Standard Deviation 18.1137	-28.889 units on a scale Standard Deviation 16.4372	-31.782 units on a scale Standard Deviation 16.7698
Change From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 24, 28, 36, 44 and 52 Week 44	-30.754 units on a scale Standard Deviation 18.5016	-30.108 units on a scale Standard Deviation 16.6013	-32.126 units on a scale Standard Deviation 15.7605
Change From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 24, 28, 36, 44 and 52 Week 52	-31.209 units on a scale Standard Deviation 18.9981	-30.512 units on a scale Standard Deviation 17.5074	-32.282 units on a scale Standard Deviation 16.6320

SECONDARY outcome

Timeframe: Baseline, Weeks 24 and 52

Population: Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

The mCPDAI assessed 4 domains (joints, skin, entheses, and dactylitis). The mCPDAI scores were calculated using the following assessments: joints (66 swollen and 68 tender joint counts), HAQ-DI score, PASI, dactylitis, and enthesitis. Within each domain a score (range 0-3) was assigned, where 0= Not involved, 1= Mild, 2= Moderate and 3= Severe. The scores for each domain were then added together to give a final score range of 0 to 12. A higher score indicates more active disease activity. Negative changes from baseline indicate improvement of PsA disease activity.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=238 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=240 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=234 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Weeks 24 and 52 Week 24	-1.34 units on a scale Standard Deviation 2.144	-2.97 units on a scale Standard Deviation 2.382	-3.32 units on a scale Standard Deviation 2.098
Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Weeks 24 and 52 Week 52	-3.75 units on a scale Standard Deviation 2.391	-3.84 units on a scale Standard Deviation 2.449	-4.10 units on a scale Standard Deviation 2.387

SECONDARY outcome

Timeframe: Weeks 24 and 52

Population: Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

The mCPDAI assessed 4 domains (joints, skin, entheses, and dactylitis). The mCPDAI scores were calculated using the following assessments: joints (66 swollen and 68 tender joint counts), HAQ-DI score, PASI, dactylitis, and enthesitis. Within each domain a score (range 0-3) was assigned, where 0= Not involved, 1= Mild, 2= Moderate and 3= Severe. The scores for each domain were then added together to give a final score range of 0 to 12. A higher score indicates more active disease activity. Negative changes from baseline indicate improvement of PsA disease activity. mCPDAI low disease activity is defined as mCPDAI score <=3.2 at the analysis visit.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=238 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=240 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=234 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants With Low Disease Activity Based on Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Weeks 24 and 52 Week 24	15.1 percentage of participants	48.9 percentage of participants	43.5 percentage of participants
Percentage of Participants With Low Disease Activity Based on Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Weeks 24 and 52 Week 52	56.3 percentage of participants	61.1 percentage of participants	60.1 percentage of participants

SECONDARY outcome

Timeframe: Weeks 24 and 52

Population: Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

MDA is a measure that defines a satisfactory state of disease activity that includes the 5 domains of PsA (joint symptoms, skin psoriasis, patient's perspective of pain and disease activity, physical function, and enthesitis). A participant was considered as having achieved the PsA MDA at a visit if the participant has fulfilled at least 5 of the following 7 criteria at that visit: Tender joint count (68 joints)<=1, Swollen joint count (66 joints) <=1, Psoriasis activity and severity index <=1, Patient's Assessment of Pain <=15 on a 100-unit VAS, Patient's Global Assessment of Disease Activity (arthritis and psoriasis) <=20 on a 100-unit VAS, HAQ-DI score <=0.5, and Tender entheseal points <= 1 (LEI index score <= 1).

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=238 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=240 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=234 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 24 and 52 Week 24	6.3 percentage of participants	26.5 percentage of participants	19.7 percentage of participants
Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 24 and 52 Week 52	31.6 percentage of participants	32.9 percentage of participants	36.8 percentage of participants

SECONDARY outcome

Timeframe: Weeks 24 and 52

Population: Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

A measurement that defines a satisfactory state of disease activity that includes the 5 domains of PsA (joint symptoms, skin psoriasis, patient's perspective of pain and disease activity, physical function, and enthesitis). A participant was considered as having achieved VLDA at a visit if the participant fulfilled all 7 criteria (tender joint count <=1; swollen joint count <=1; PASI <=1; patient pain VAS score of <=15; patient global disease activity VAS [arthritis and psoriasis] score of <=20; Health Assessment Questionnaire (HAQ) score <=0.5; and tender entheseal points <=1) at that visit.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=238 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=240 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=234 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants With Very Low Disease Activity (VLDA) at Weeks 24 and 52 Week 24	1.3 percentage of participants	4.6 percentage of participants	5.1 percentage of participants
Percentage of Participants With Very Low Disease Activity (VLDA) at Weeks 24 and 52 Week 52	6.9 percentage of participants	17.1 percentage of participants	12.2 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 24 and 52

Population: Analysis population is FAS2 among the participants with spondylitis and peripheral arthritis and BASDAI score \>0 at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a self-assessment tool that consists of 6 questions relating to the 5 major symptoms of ankylosing spondylitis: fatigue, spinal pain, joint pain, enthesitis, qualitative morning stiffness and quantitative morning stiffness. The first 5 items were scored on a 10 centimeter (cm) VAS ranging from 0=none to 10=very severe. Quantitative morning stiffness was scored on a 10cm VAS ranging from 0=0 hours to 10=2 or more hours. The 2 scores for qualitative and quantitative morning stiffness were averaged, and the total BASDAI score was the average of the 5 scores of each symptom, ranging from 0 (none) to 10 (very severe). Higher scores indicate greater disease severity and an improvement of 50% from baseline is considered clinically meaningful. Only participants with spondylitis and peripheral arthritis as their primary arthritic presentation of PsA completed the BASDAI indicate the degree of their symptoms over the past week.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=91 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=66 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=79 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Weeks 24 and 52 Among Participants With Spondylitis and Peripheral Arthritis at Baseline Week 24	-1.374 units on a scale Standard Deviation 2.4269	-2.652 units on a scale Standard Deviation 2.3825	-2.674 units on a scale Standard Deviation 1.9941
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Weeks 24 and 52 Among Participants With Spondylitis and Peripheral Arthritis at Baseline Week 52	-2.986 units on a scale Standard Deviation 2.4945	-2.883 units on a scale Standard Deviation 2.5193	-3.084 units on a scale Standard Deviation 2.1843

SECONDARY outcome

Timeframe: Weeks 24 and 52

Population: Analysis population is FAS2 among the participants with spondylitis and peripheral arthritis and BASDAI score \>0 at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a self-assessment tool that consists of 6 questions relating to the 5 major symptoms of ankylosing spondylitis: fatigue, spinal pain, joint pain, enthesitis, qualitative morning stiffness and quantitative morning stiffness. The first 5 items were scored on a 10 centimeter (cm) VAS ranging from 0=none to 10=very severe. Quantitative morning stiffness was scored on a 10cm VAS ranging from 0=0 hours to 10=2 or more hours. The 2 scores for qualitative and quantitative morning stiffness were averaged, and the total BASDAI score was the average of the 5 scores of each symptom, ranging from 0 (none) to 10 (very severe). Higher scores indicate greater disease severity and an improvement of 50% from baseline is considered clinically meaningful. Only participants with spondylitis and peripheral arthritis as their primary arthritic presentation of PsA completed the BASDAI indicate the degree of their symptoms over the past week.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=91 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=66 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=79 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 24 and 52 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline Week 24: Participants with >=20% Improvement	44.0 percentage of participants	62.5 percentage of participants	73.1 percentage of participants
Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 24 and 52 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline Week 52: Participants with >=20% Improvement	71.6 percentage of participants	70.3 percentage of participants	79.7 percentage of participants
Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 24 and 52 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline Week 24: Participants with >=50% Improvement	22.0 percentage of participants	40.6 percentage of participants	39.7 percentage of participants
Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 24 and 52 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline Week 52: Participants with >=50% Improvement	50.0 percentage of participants	42.2 percentage of participants	50.6 percentage of participants
Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 24 and 52 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline Week 24: Participants with >=70% Improvement	8.8 percentage of participants	21.9 percentage of participants	16.7 percentage of participants
Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 24 and 52 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline Week 52: Participants with >=70% Improvement	23.9 percentage of participants	26.6 percentage of participants	30.4 percentage of participants
Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 24 and 52 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline Week 24: Participants with >=90% Improvement	2.2 percentage of participants	1.6 percentage of participants	3.8 percentage of participants
Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 24 and 52 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline Week 52: Participants with >=90% Improvement	6.8 percentage of participants	10.9 percentage of participants	8.9 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 24 and 52

Population: Analysis population is FAS2 among the participants who had \>=3% BSA of psoriatic involvement and an IGA score \>=2 (mild) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. Negative change from baseline indicates improvement of psoriasis.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=176 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=173 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=177 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in PASI Score at Weeks 24 and 52 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 24	-2.989 units on a scale Standard Deviation 6.1515	-11.685 units on a scale Standard Deviation 12.3496	-12.574 units on a scale Standard Deviation 11.8391
Change From Baseline in PASI Score at Weeks 24 and 52 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 52	-11.016 units on a scale Standard Deviation 9.9801	-11.977 units on a scale Standard Deviation 12.0847	-12.857 units on a scale Standard Deviation 11.3052

SECONDARY outcome

Timeframe: Weeks 24 and 52

Population: Analysis population is FAS2 among the participants who had \>=3% BSA of psoriatic involvement and an IGA score \>=2 (mild) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severity. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. PASI 50 response: >=50% improvement in PASI score from baseline.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=176 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=173 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=177 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved PASI 50 Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 24	39.8 percentage of participants	94.8 percentage of participants	93.8 percentage of participants
Percentage of Participants Who Achieved PASI 50 Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 52	95.9 percentage of participants	97.1 percentage of participants	98.3 percentage of participants

SECONDARY outcome

Timeframe: Weeks 24 and 52

Population: Analysis population is FAS2 among the participants who had \>=3% BSA of psoriatic involvement and an IGA score \>=2 (mild) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severity. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. PASI 75 response: >=75% improvement in PASI score from baseline.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=176 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=173 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=177 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved PASI 75 Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 24	23.3 percentage of participants	80.8 percentage of participants	81.8 percentage of participants
Percentage of Participants Who Achieved PASI 75 Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 52	88.4 percentage of participants	88.8 percentage of participants	91.9 percentage of participants

SECONDARY outcome

Timeframe: Weeks 24 and 52

Population: Analysis population is FAS2 among the participants who had \>=3% BSA of psoriatic involvement and an IGA score \>=2 (mild) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severity. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. PASI 90 response: >=90% improvement in PASI score from baseline.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=176 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=173 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=177 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved PASI 90 Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 24	10.2 percentage of participants	70.3 percentage of participants	63.6 percentage of participants
Percentage of Participants Who Achieved PASI 90 Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 52	76.7 percentage of participants	77.1 percentage of participants	81.5 percentage of participants

SECONDARY outcome

Timeframe: Weeks 24 and 52

Population: Analysis population is FAS2 among the participants who had \>=3% BSA of psoriatic involvement and an IGA score \>=2 (mild) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severity. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. PASI 100 response: 100% improvement in PASI score from baseline.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=176 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=173 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=177 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved PASI 100 Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 24	2.8 percentage of participants	46.5 percentage of participants	46.6 percentage of participants
Percentage of Participants Who Achieved PASI 100 Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 52	55.2 percentage of participants	54.7 percentage of participants	61.3 percentage of participants

SECONDARY outcome

Timeframe: Weeks 24 and 52

Population: Analysis population is FAS2 among the participants who had \>=3% BSA of psoriatic involvement and an IGA score \>=2 (mild) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

In PASI, each area (head, trunk, upper and lower extremities) was assessed for % of area involved and translated to numeric score from 0 (no involvement) to 6 (90-100% involvement) and for erythema, induration, and scaling, each rated on scale of 0 to 4. PASI produces numeric score from 0 to 72. Higher scores=more severe disease. PASI 75: >=75% improvement in PASI score from baseline. ACR 20: >=20% improvement in SJC (66 joints)+TJC (68 joints) and >=20% improvement in 3 of 5: patient's assessment of pain (VAS; 0-100 mm, 0=no pain to 100=worst possible pain), PtGA of disease activity (VAS; 0-100 mm, 0=excellent to 100=poor), PGA of disease activity (VAS; 0-100 mm, 0=no arthritis to 100=extremely active arthritis), patient's assessment of physical function (HAQ-DI -20-question instrument; range- 0=no difficulty to 3=inability to perform task) and CRP.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=176 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=173 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=177 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved Both PASI 75 and ACR 20 Responses at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 24	11.4 percentage of participants	58.1 percentage of participants	59.7 percentage of participants
Percentage of Participants Who Achieved Both PASI 75 and ACR 20 Responses at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 52	59.6 percentage of participants	73.5 percentage of participants	69.9 percentage of participants

SECONDARY outcome

Timeframe: Weeks 24 and 52

Population: Analysis population is FAS2 among the participants who had \>=3% BSA of psoriatic involvement and an IGA score \>=2 (mild) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

In PASI, each area (head, trunk, upper and lower extremities) was assessed separately for % of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90-100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4. PASI produces numeric score range from 0 to 72. Higher scores=more severe disease. PASI75 response: >=75% improvement in PASI score from baseline. Modified PsARC response: improvement in at least 2 of 4 criteria: >=30% decrease in SJC and TJC, >=20% improvement in PtGA of Disease Activity (arthritis) on VAS (0-100 mm, 0=excellent and 100=poor), >=20% improvement in PGA of Disease Activity on VAS (VAS: 0-100 mm, 0=no arthritis and 100=extremely active arthritis), and at least 1 of 2 joint criteria with no deterioration in other criteria.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=176 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=173 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=177 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved Both PASI 75 and Modified PsARC Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 24	15.3 percentage of participants	66.9 percentage of participants	63.6 percentage of participants
Percentage of Participants Who Achieved Both PASI 75 and Modified PsARC Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 52	70.9 percentage of participants	79.4 percentage of participants	76.3 percentage of participants

SECONDARY outcome

Timeframe: Weeks 24 and 52

Population: Analysis population is FAS2 among the participants who had \>=3% BSA of psoriatic involvement and an IGA score \>=2 (mild) at baseline.

A psoriasis IGA response was defined as an IGA score of 0 (cleared) or 1 (minimal) and >= 2 grade reduction from baseline in the IGA psoriasis score. The IGA documents the investigator's assessment of the patient's psoriasis and lesions are graded for induration, erythema and scaling, each using a 5 point scale: 0 (no evidence), 1 (minimal), 2 (mild), 3 (moderate), and 4 (severe). The IGA score of psoriasis was based upon the average of induration, erythema and scaling scores. The participant's psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=176 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=173 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=177 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved an IGA Response at Weeks 24 and 52 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 24	19.9 percentage of participants	72.1 percentage of participants	71.0 percentage of participants
Percentage of Participants Who Achieved an IGA Response at Weeks 24 and 52 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 52	84.3 percentage of participants	77.1 percentage of participants	84.4 percentage of participants

SECONDARY outcome

Timeframe: Weeks 24 and 52

Population: Analysis population is FAS2 among the participants who had \>=3% BSA of psoriatic involvement and an IGA score \>=2 (mild) at baseline.

A psoriasis IGA response was defined as an IGA score of 0 (cleared) or 1 (minimal) and >= 2 grade reduction from baseline in the IGA psoriasis score. The IGA documents the investigator's assessment of the patient's psoriasis and lesions are graded for induration, erythema and scaling, each using a 5 point scale: 0 (no evidence), 1 (minimal), 2 (mild), 3 (moderate), and 4 (severe). The IGA score of psoriasis was based upon the average of induration, erythema and scaling scores. The participant's psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=176 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=173 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=177 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved an IGA Score of 0 (Cleared) at Weeks 24 and 52 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 24	8.0 percentage of participants	51.2 percentage of participants	52.8 percentage of participants
Percentage of Participants Who Achieved an IGA Score of 0 (Cleared) at Weeks 24 and 52 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 52	66.9 percentage of participants	60.0 percentage of participants	66.5 percentage of participants

SECONDARY outcome

Timeframe: Weeks 24 and 52

Population: Analysis population is FAS2 among the participants with DLQI Score \>1, with \>=3% BSA psoriatic involvement and an IGA score of \>=2 (mild) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Dermatology Life Quality Index (DLQI) is a 10-item instrument questionnaire used to assess the patient's perspective of the impact of psoriasis on daily living. Each item was scored on a 4-point scale (0 =not at all /not relevant; 1 =a little; 2 =a lot; 3 =very much), and the total score (0-30) is the sum of the 10 items. The higher the score, the more quality of life is impaired. A DLQI score of 0 or 1 indicates psoriasis had no effect at all on patient's life.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=165 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=155 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=166 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved a DLQI Score of 0 or 1 at Weeks 24 and 52 Among the Participants With DLQI Score >1, With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 24	12.1 percentage of participants	65.6 percentage of participants	61.4 percentage of participants
Percentage of Participants Who Achieved a DLQI Score of 0 or 1 at Weeks 24 and 52 Among the Participants With DLQI Score >1, With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 52	56.8 percentage of participants	68.6 percentage of participants	68.7 percentage of participants

SECONDARY outcome

Timeframe: Weeks 24 and 52

Population: Analysis population is FAS2 among the participants with DLQI score \>=5, \>=3% BSA psoriatic involvement and an IGA score of \>=2 (mild) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Dermatology Life Quality Index (DLQI) is a 10-item instrument questionnaire used to assess the patient's perspective of the impact of psoriasis on daily living. Each item was scored on a 4-point scale (0 =not at all /not relevant; 1 =a little; 2 =a lot; 3 =very much), and the total score (0-30) is the sum of the 10 items. The higher the score, the more quality of life is impaired. An improvement of 5 points was considered clinically meaningful.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=140 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=131 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=145 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved >=5-point Improvement From Baseline in DLQI Score at Weeks 24 and 52 Among the Participants With DLQI Score >=5, >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 52	84.8 percentage of participants	92.2 percentage of participants	89.4 percentage of participants
Percentage of Participants Who Achieved >=5-point Improvement From Baseline in DLQI Score at Weeks 24 and 52 Among the Participants With DLQI Score >=5, >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 24	40.7 percentage of participants	85.4 percentage of participants	90.3 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 24 and 52

Population: Analysis population is FAS2 among the participants with \>=3% BSA psoriatic involvement and an IGA Score of \>=2 (mild) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Dermatology Life Quality Index (DLQI) is a 10-item instrument questionnaire used to assess the patient's perspective of the impact of psoriasis on daily living. Each item was scored on a 4-point scale (0 =not at all /not relevant; 1 =a little; 2 =a lot; 3 =very much), and the total score (0-30) is the sum of the 10 items. The higher the score, the more quality of life is impaired. Negative changes from baseline indicate improvement of life quality impacted by psoriasis.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=176 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=173 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=177 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in DLQI Score at Weeks 24 and 52 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 24	-2.142 units on a scale Standard Deviation 6.4593	-8.901 units on a scale Standard Deviation 7.3657	-9.249 units on a scale Standard Deviation 7.0988
Change From Baseline in DLQI Score at Weeks 24 and 52 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 52	-8.815 units on a scale Standard Deviation 7.2714	-9.235 units on a scale Standard Deviation 7.3840	-9.839 units on a scale Standard Deviation 6.8777

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: FAS2 for structural damage (FAS2-SD) among all randomized participants who were continuing study treatment at Week 24. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=230 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=235 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=229 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in Modified vdH-S Score at Week 52	1.25 units on a scale Standard Deviation 3.508	0.97 units on a scale Standard Deviation 3.623	1.07 units on a scale Standard Deviation 3.843

SECONDARY outcome

Timeframe: From Week 24 to Week 52

Population: FAS2 for structural damage (FAS2-SD) among all randomized participants who were continuing study treatment at Week 24. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=230 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=235 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=229 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change in Total Modified vdH-S Score From Week 24 to Week 52	0.25 units on a scale Standard Deviation 1.635	0.23 units on a scale Standard Deviation 1.808	0.62 units on a scale Standard Deviation 2.530

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: FAS2 for structural damage (FAS2-SD) among all randomized participants who were continuing study treatment at Week 24. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=230 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=235 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=229 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in Modified vdH-S Erosion Score at Week 52	0.92 units on a scale Standard Deviation 2.497	0.67 units on a scale Standard Deviation 2.707	0.70 units on a scale Standard Deviation 2.631

SECONDARY outcome

Timeframe: From Week 24 to Week 52

Population: FAS2 for structural damage (FAS2-SD) among all randomized participants who were continuing study treatment at Week 24. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=230 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=235 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=229 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change in Modified vdH-S Erosion Score From Week 24 to Week 52	0.17 units on a scale Standard Deviation 1.277	0.10 units on a scale Standard Deviation 1.422	0.39 units on a scale Standard Deviation 1.725

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: FAS2 for structural damage (FAS2-SD) among all randomized participants who were continuing study treatment at Week 24. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=230 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=235 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=229 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in Modified vdH-S JSN Score at Week 52	0.33 units on a scale Standard Deviation 1.356	0.29 units on a scale Standard Deviation 1.272	0.38 units on a scale Standard Deviation 1.633

SECONDARY outcome

Timeframe: From Week 24 to Week 52

Population: FAS2 for structural damage (FAS2-SD) among all randomized participants who were continuing study treatment at Week 24. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=230 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=235 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=229 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change in Modified vdH-S JSN Score From Week 24 to Week 52	0.07 units on a scale Standard Deviation 0.635	0.13 units on a scale Standard Deviation 0.705	0.23 units on a scale Standard Deviation 1.088

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: FAS2 for structural damage (FAS2-SD) among all randomized participants who were continuing study treatment at Week 24. Here, 'n' (number analyzed) signifies the number of participants analyzed for a specified score.

Modified vdH-S score is the sum of the erosion score (hand, feet) and JSN score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand (Hand erosion score) scored according to 0 (no erosion) to 5 (complete collapse of bone) for a maximum hand erosion score of 200, and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum foot erosion score of 120. Higher scores indicate more joint damage. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum Hand JSN score of 160 and maximum Foot JSN score of 48. Higher scores indicate more joint damage. Hand Score (sum of Hand Erosion Score and Hand JSN Score) scored as 0-360 and Foot score (sum of foot erosion score and foot JSN score) scored as 0-168. Higher scores indicate more joint damage.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=238 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=240 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=234 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) at Week 52 Hand JSN Score	0.29 units on a scale Standard Deviation 1.181	0.19 units on a scale Standard Deviation 0.913	0.22 units on a scale Standard Deviation 1.235
Change From Baseline in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) at Week 52 Foot Erosion Score	0.26 units on a scale Standard Deviation 1.014	0.30 units on a scale Standard Deviation 1.339	0.34 units on a scale Standard Deviation 1.413
Change From Baseline in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) at Week 52 Hand Erosion Score	0.66 units on a scale Standard Deviation 1.815	0.37 units on a scale Standard Deviation 1.969	0.35 units on a scale Standard Deviation 1.830
Change From Baseline in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) at Week 52 Hand Score	0.95 units on a scale Standard Deviation 2.706	0.56 units on a scale Standard Deviation 2.589	0.57 units on a scale Standard Deviation 2.759
Change From Baseline in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) at Week 52 Foot JSN Score	0.04 units on a scale Standard Deviation 0.353	0.10 units on a scale Standard Deviation 0.660	0.16 units on a scale Standard Deviation 0.864
Change From Baseline in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) at Week 52 Foot Score	0.30 units on a scale Standard Deviation 1.220	0.40 units on a scale Standard Deviation 1.687	0.50 units on a scale Standard Deviation 1.939

SECONDARY outcome

Timeframe: Week 52

Population: FAS2 for structural damage (FAS2-SD) among all randomized participants who were continuing study treatment at Week 24. Here, n (number analyzed) signifies the number of participants analyzed at specified category.

Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=238 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=240 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=234 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Score at Week 52 Change of <=0 from Baseline	57.4 percentage of participants	55.7 percentage of participants	56.8 percentage of participants
Percentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Score at Week 52 Change of <=0.5 from Baseline	67.4 percentage of participants	67.2 percentage of participants	72.1 percentage of participants

SECONDARY outcome

Timeframe: Week 52

Population: FAS2 for structural damage (FAS2-SD) among all randomized participants who were continuing study treatment at Week 24. Here, n (number analyzed) signifies the number of participants analyzed at specified category.

Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=238 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=240 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=234 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Erosion Score at Week 52 Change of <=0 from Baseline	58.3 percentage of participants	59.6 percentage of participants	60.3 percentage of participants
Percentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Erosion Score at Week 52 Change of <=0.5 from Baseline	70.4 percentage of participants	71.1 percentage of participants	72.1 percentage of participants

SECONDARY outcome

Timeframe: Week 52

Population: FAS2 for structural damage (FAS2-SD) among all randomized participants who were continuing study treatment at Week 24. Here, n (number analyzed) signifies the number of participants analyzed at specified category.

Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=238 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=240 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=234 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S JSN Score at Week 52 Change of <=0 from Baseline	78.7 percentage of participants	75.3 percentage of participants	79.5 percentage of participants
Percentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S JSN Score at Week 52 Change of <=0.5 from Baseline	88.3 percentage of participants	86.0 percentage of participants	86.5 percentage of participants

SECONDARY outcome

Timeframe: Week 52

Population: FAS2 for structural damage (FAS2-SD) among all randomized participants who were continuing study treatment at Week 24. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Modified vdH-S score is the sum of the erosion score (hand, feet) and JSN score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. SDC was defined as the cut-off above which the changes can be detected beyond measurement error. Without radiographic progression was defined as change from baseline in the modified vdH-S score <=SDC of 2.39.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=230 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=235 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=229 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Without Radiographic Progression Based on the (SDC) From Baseline at Week 52	80.4 percentage of participants	82.6 percentage of participants	85.2 percentage of participants

SECONDARY outcome

Timeframe: Week 52

Population: FAS2 for structural damage (FAS2-SD) among all randomized participants who were continuing study treatment at Week 24. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Modified vdH-S score is sum of the erosion score (hand, feet) and JSN score (hand, feet). Joint erosion score is summary of erosion severity in 40 joints of hand scored according to surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is total JSN score in same 52 joints as above, each joint scored according to subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. SDC was defined as the cut-off above which the changes can be detected beyond measurement error. Without radiographic joint erosion progression was defined as change from baseline in modified vdH-S erosion score <=SDC of 2.22.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=230 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=235 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=229 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Without Radiographic Joint Erosion Progression Based on (SDC) From Baseline at Week 52	82.2 percentage of participants	84.3 percentage of participants	87.3 percentage of participants

SECONDARY outcome

Timeframe: Week 52

Population: FAS2 for structural damage (FAS2-SD) among all randomized participants who were continuing study treatment at Week 24. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Modified vdH-S score is sum of erosion score (hand, feet) and JSN score (hand, feet). Joint erosion score is summary of erosion severity in 40 joints of hand scored according to surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is total JSN score in same 52 joints as above, each joint scored according to subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. SDC was defined as cut-off above which changes can be detected beyond measurement error. Without radiographic JSN progression was defined as change from baseline in modified vdH-S JSN score <=SDC of 1.02.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=230 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=235 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=229 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Without Radiographic JSN Progression Based on (SDC) From Baseline at Week 52	91.3 percentage of participants	91.5 percentage of participants	90.4 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: FAS2 for structural damage (FAS2-SD) among all randomized participants who were continuing study treatment at Week 24. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Percentage of Participants with Pencil in cup or Gross Osteolysis Deformities were reported. Pencil in Cup or Gross Osteolytis Deformities are radiographic features specific for psoriatic arthritis.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=238 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=240 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=234 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline and Week 52 Baseline	6.9 percentage of participants	4.6 percentage of participants	6.9 percentage of participants
Percentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline and Week 52 Week 52	7.8 percentage of participants	5.1 percentage of participants	7.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 24 and 52

Population: Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The PCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=238 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=240 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=234 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in SF-36 PCS Score at Weeks 24 and 52 Week 24	3.782 units on a scale Standard Deviation 7.1776	7.838 units on a scale Standard Deviation 8.0335	7.183 units on a scale Standard Deviation 6.9793
Change From Baseline in SF-36 PCS Score at Weeks 24 and 52 Week 52	8.124 units on a scale Standard Deviation 8.2192	9.511 units on a scale Standard Deviation 8.3176	8.960 units on a scale Standard Deviation 8.5891

SECONDARY outcome

Timeframe: Baseline, Weeks 24 and 52

Population: Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The MCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=238 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=240 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=234 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in SF-36 MCS Score at Weeks 24 and 52 Week 24	2.211 units on a scale Standard Deviation 10.1368	4.452 units on a scale Standard Deviation 9.9560	4.128 units on a scale Standard Deviation 9.1814
Change From Baseline in SF-36 MCS Score at Weeks 24 and 52 Week 52	4.297 units on a scale Standard Deviation 10.8960	4.465 units on a scale Standard Deviation 9.7780	4.076 units on a scale Standard Deviation 9.1101

SECONDARY outcome

Timeframe: Baseline, Weeks 24 and 52

Population: Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales: physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health. The scores 0-100 (where higher scores indicated a better quality of life) from each subscale of SF-36 were normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. Higher score indicates better health status. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=238 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=240 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=234 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 Week 24: Physical Function Score	3.602 units on a scale Standard Deviation 7.7388	7.052 units on a scale Standard Deviation 8.5020	6.772 units on a scale Standard Deviation 7.5920
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 Week 52: Physical Function Score	7.722 units on a scale Standard Deviation 8.9480	8.489 units on a scale Standard Deviation 8.8599	8.374 units on a scale Standard Deviation 8.7884
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 Week 24: Role-physical Score	3.695 units on a scale Standard Deviation 7.5950	6.897 units on a scale Standard Deviation 7.7240	6.381 units on a scale Standard Deviation 7.2203
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 Week 52: Role-physical Score	6.560 units on a scale Standard Deviation 8.5399	7.677 units on a scale Standard Deviation 8.2995	7.344 units on a scale Standard Deviation 7.7145
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 Week 24: Bodily Pain Score	3.882 units on a scale Standard Deviation 8.3009	8.333 units on a scale Standard Deviation 8.3852	7.833 units on a scale Standard Deviation 7.3390
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 Week 52: Bodily Pain Score	8.460 units on a scale Standard Deviation 8.4659	10.238 units on a scale Standard Deviation 8.7185	9.457 units on a scale Standard Deviation 9.7977
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 Week 24: General Health Score	2.255 units on a scale Standard Deviation 7.2176	5.963 units on a scale Standard Deviation 7.8794	5.067 units on a scale Standard Deviation 7.4182
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 Week 52: General Health Score	6.396 units on a scale Standard Deviation 8.5589	7.173 units on a scale Standard Deviation 7.2703	6.366 units on a scale Standard Deviation 8.4199
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 Week 24: Vitality Score	4.224 units on a scale Standard Deviation 9.0878	7.914 units on a scale Standard Deviation 9.4638	6.970 units on a scale Standard Deviation 9.4889
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 Week 52: Vitality Score	7.879 units on a scale Standard Deviation 9.4160	8.646 units on a scale Standard Deviation 9.5131	7.654 units on a scale Standard Deviation 9.3905
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 Week 24: Social Function Score	3.088 units on a scale Standard Deviation 10.4330	6.551 units on a scale Standard Deviation 9.7076	5.892 units on a scale Standard Deviation 8.5510
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 Week 52: Social Function Score	6.278 units on a scale Standard Deviation 10.9444	7.199 units on a scale Standard Deviation 10.1315	6.787 units on a scale Standard Deviation 9.5326
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 Week 24: Role-emotional Score	1.910 units on a scale Standard Deviation 10.0772	4.535 units on a scale Standard Deviation 10.1304	4.107 units on a scale Standard Deviation 8.9473
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 Week 52: Role-emotional Score	4.057 units on a scale Standard Deviation 10.8795	4.970 units on a scale Standard Deviation 10.1685	4.607 units on a scale Standard Deviation 8.7627
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 Week 24: Mental Health Score	2.583 units on a scale Standard Deviation 9.2222	4.605 units on a scale Standard Deviation 9.7905	4.752 units on a scale Standard Deviation 8.9336
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 Week 52: Mental Health Score	5.153 units on a scale Standard Deviation 10.0724	4.829 units on a scale Standard Deviation 9.3665	4.741 units on a scale Standard Deviation 9.3825

SECONDARY outcome

Timeframe: Weeks 24 and 52

Population: Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The PCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. Higher score indicates better outcome, with an increase of 5 points considered to be clinically meaningful.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=238 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=240 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=234 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score at Weeks 24 and 52 Week 24	42.2 percentage of participants	63.4 percentage of participants	58.5 percentage of participants
Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score at Weeks 24 and 52 Week 52	63.0 percentage of participants	67.1 percentage of participants	65.5 percentage of participants

SECONDARY outcome

Timeframe: Weeks 24 and 52

Population: Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The MCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. Higher score indicates better outcome, with an increase of 5 points considered to be clinically meaningful.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=238 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=240 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=234 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score at Weeks 24 and 52 Week 24	32.5 percentage of participants	40.3 percentage of participants	36.8 percentage of participants
Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score at Weeks 24 and 52 Week 52	41.7 percentage of participants	44.9 percentage of participants	38.9 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 24 and 52

Population: Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

The FACIT-Fatigue is a questionnaire that assesses self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue. The subscale consists 13-item instrument to measure fatigue. Each of the 13 items has a set of five response categories: Not at all (=0), A little bit (=1), Somewhat (=2), Quite a bit (=3) and Very much (=4). A total FACIT-Fatigue subscale score was calculated as the sum of the 13 item scores (reserved scores [4 - score]) and ranges from 0 to 52, with a higher score indicating less fatigue. Positive changes from baseline indicate improvement of fatigue. Items were reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatigue.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=238 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=240 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=234 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in FACIT-Fatigue Score at Weeks 24 and 52 Week 24	3.844 units on a scale Standard Deviation 9.0440	8.034 units on a scale Standard Deviation 9.8888	6.970 units on a scale Standard Deviation 8.6274
Change From Baseline in FACIT-Fatigue Score at Weeks 24 and 52 Week 52	7.548 units on a scale Standard Deviation 9.3745	8.927 units on a scale Standard Deviation 9.4646	7.686 units on a scale Standard Deviation 9.0833

SECONDARY outcome

Timeframe: Weeks 24 and 52

Population: Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

The FACIT-Fatigue is a questionnaire that assesses self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue. The subscale consists 13-item instrument to measure fatigue. Each of the 13 items has a set of five response categories: Not at all (=0), A little bit (=1), Somewhat (=2), Quite a bit (=3) and Very much (=4). A total FACIT-Fatigue subscale score was calculated as the sum of the 13 item scores (reserved scores [4 - score]) and ranges from 0 to 52, with a higher score indicating less fatigue. Items were reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatigue.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=238 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=240 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=234 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score Improvement at Weeks 24 and 52 Week 24	49.4 percentage of participants	63.9 percentage of participants	62.8 percentage of participants
Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score Improvement at Weeks 24 and 52 Week 52	68.3 percentage of participants	69.7 percentage of participants	68.6 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 24 and 52

Population: Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. The EQ VAS self-rating records the respondent's own assessment of his or her overall health status at the time of completion, on a vertical line VAS with scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine). A higher score indicates better health and positive changes from baseline indicate improvement of health status.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=238 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=240 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=234 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in EQ-5D-5L at Weeks 24 and 52: EQ-VAS Week 24	8.456 units on a scale Standard Deviation 25.7204	19.282 units on a scale Standard Deviation 23.5220	17.500 units on a scale Standard Deviation 22.6981
Change From Baseline in EQ-5D-5L at Weeks 24 and 52: EQ-VAS Week 52	21.474 units on a scale Standard Deviation 25.5974	23.295 units on a scale Standard Deviation 23.6270	19.983 units on a scale Standard Deviation 24.7643

SECONDARY outcome

Timeframe: Baseline, Weeks 24 and 52

Population: Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health "today". Responses were used to generate a weighted summary index (EQ-5D index), which ranges from 0 (dead) to 1.00 (full health). A higher score indicates better health and positive changes from baseline indicate improvement of health.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=238 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=240 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=234 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in EQ-5D-5L at Weeks 24 and 52: EQ-5D Index Week 24	0.060 units on a scale Standard Deviation 0.1558	0.124 units on a scale Standard Deviation 0.1476	0.117 units on a scale Standard Deviation 0.1307
Change From Baseline in EQ-5D-5L at Weeks 24 and 52: EQ-5D Index Week 52	0.137 units on a scale Standard Deviation 0.1605	0.146 units on a scale Standard Deviation 0.1587	0.135 units on a scale Standard Deviation 0.1469

SECONDARY outcome

Timeframe: Baseline, Weeks 24 and 52

Population: Analysis population is FAS2. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Work Productivity and Activity Impairment was assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) of PsA (WPAI-PsA). The WPAI-PsA consisted of 6 questions to determine employment status, hours missed from work due to PsA, hours missed from work for other reasons, hours actually worked, the degree to which PsA affected work productivity while at work and the degree to which PsA affected activities outside of work during the past 7 days. WPAI outcomes included percent work time missed due to PsA, percent impairment while working due to PsA, percent overall work impairment due to PsA, and percent activity impairment outside of work due to PsA. These WPAI outcomes were expressed as impairment percentages (0-100, 0=no impairment and 100=100% impaired), with higher numbers indicating greater impairment and less productivity. Negative changes from baseline indicate improvement of work productivity and activity impairment.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=148 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=141 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=136 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire Scores (Percent Work Time Missed) at Weeks 24 and 52 Week 24	-5.64 units on a scale Standard Deviation 28.355	-3.77 units on a scale Standard Deviation 28.029	-1.20 units on a scale Standard Deviation 17.127
Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire Scores (Percent Work Time Missed) at Weeks 24 and 52 Week 52	-5.37 units on a scale Standard Deviation 25.365	-4.47 units on a scale Standard Deviation 20.454	-1.74 units on a scale Standard Deviation 17.084

SECONDARY outcome

Timeframe: Baseline, Weeks 24 and 52

Population: Analysis population is FAS2. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Work Productivity and Activity Impairment was assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) of PsA (WPAI-PsA). The WPAI-PsA consisted of 6 questions to determine employment status, hours missed from work due to PsA, hours missed from work for other reasons, hours actually worked, the degree to which PsA affected work productivity while at work and the degree to which PsA affected activities outside of work during the past 7 days. WPAI outcomes included percent work time missed due to PsA, percent impairment while working due to PsA, percent overall work impairment due to PsA, and percent activity impairment outside of work due to PsA. These WPAI outcomes were expressed as impairment percentages (0-100, 0=no impairment and 100=100% impaired), with higher numbers indicating greater impairment and less productivity. Negative changes from baseline indicate improvement of work productivity and activity impairment.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=126 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=125 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=124 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in WPAI Scores (Percent Impairment While Working) at Weeks 24 and 52 Week 24	-12.14 units on a scale Standard Deviation 29.027	-21.28 units on a scale Standard Deviation 25.621	-20.08 units on a scale Standard Deviation 22.084
Change From Baseline in WPAI Scores (Percent Impairment While Working) at Weeks 24 and 52 Week 52	-21.27 units on a scale Standard Deviation 31.502	-27.93 units on a scale Standard Deviation 25.263	-22.10 units on a scale Standard Deviation 26.172

SECONDARY outcome

Timeframe: Baseline, Weeks 24 and 52

Population: Analysis population is FAS2. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Work Productivity and Activity Impairment was assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) of PsA (WPAI-PsA). The WPAI-PsA consisted of 6 questions to determine employment status, hours missed from work due to PsA, hours missed from work for other reasons, hours actually worked, the degree to which PsA affected work productivity while at work and the degree to which PsA affected activities outside of work during the past 7 days. WPAI outcomes included percent work time missed due to PsA, percent impairment while working due to PsA, percent overall work impairment due to PsA, and percent activity impairment outside of work due to PsA. These WPAI outcomes were expressed as impairment percentages (0-100, 0=no impairment and 100=100% impaired), with higher numbers indicating greater impairment and less productivity. Negative changes from baseline indicate improvement of work productivity and activity impairment.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=126 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=125 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=124 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in WPAI Scores (Percent Overall Work Impairment) at Weeks 24 and 52 Week 24	-13.42 units on a scale Standard Deviation 29.916	-21.68 units on a scale Standard Deviation 27.065	-20.90 units on a scale Standard Deviation 22.814
Change From Baseline in WPAI Scores (Percent Overall Work Impairment) at Weeks 24 and 52 Week 52	-22.06 units on a scale Standard Deviation 32.092	-28.19 units on a scale Standard Deviation 25.536	-22.24 units on a scale Standard Deviation 26.920

SECONDARY outcome

Timeframe: Baseline, Weeks 24 and 52

Population: Analysis population is FAS2. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Work Productivity and Activity Impairment was assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) of PsA (WPAI-PsA). The WPAI-PsA consisted of 6 questions to determine employment status, hours missed from work due to PsA, hours missed from work for other reasons, hours actually worked, the degree to which PsA affected work productivity while at work and the degree to which PsA affected activities outside of work during the past 7 days. WPAI outcomes included percent work time missed due to PsA, percent impairment while working due to PsA, percent overall work impairment due to PsA, and percent activity impairment outside of work due to PsA. These WPAI outcomes were expressed as impairment percentages (0-100, 0=no impairment and 100=100% impaired), with higher numbers indicating greater impairment and less productivity. Negative changes from baseline indicate improvement of work productivity and activity impairment.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=237 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=238 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=234 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in WPAI Scores (Percent Activity Impairment Outside of Work) at Weeks 24 and 52 Week 24	-10.80 units on a scale Standard Deviation 26.131	-23.03 units on a scale Standard Deviation 25.559	-21.07 units on a scale Standard Deviation 21.493
Change From Baseline in WPAI Scores (Percent Activity Impairment Outside of Work) at Weeks 24 and 52 Week 52	-24.13 units on a scale Standard Deviation 27.436	-27.14 units on a scale Standard Deviation 25.657	-26.11 units on a scale Standard Deviation 25.361

SECONDARY outcome

Timeframe: Weeks 52, 68, 76, 84 and 100

Population: Analysis population is full analysis set 3 (FAS3) which included all participants still on treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

ACR 20 response was defined as >=20% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=20% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=228 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=232 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=227 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved ACR 20 Response at Weeks 52, 68, 76, 84 and 100 Week 52	68.7 percentage of participants	78.9 percentage of participants	77.0 percentage of participants
Percentage of Participants Who Achieved ACR 20 Response at Weeks 52, 68, 76, 84 and 100 Week 68	77.0 percentage of participants	85.2 percentage of participants	80.7 percentage of participants
Percentage of Participants Who Achieved ACR 20 Response at Weeks 52, 68, 76, 84 and 100 Week 76	75.6 percentage of participants	83.1 percentage of participants	82.5 percentage of participants
Percentage of Participants Who Achieved ACR 20 Response at Weeks 52, 68, 76, 84 and 100 Week 84	80.1 percentage of participants	85.1 percentage of participants	80.6 percentage of participants
Percentage of Participants Who Achieved ACR 20 Response at Weeks 52, 68, 76, 84 and 100 Week 100	79.2 percentage of participants	82.1 percentage of participants	84.9 percentage of participants

SECONDARY outcome

Timeframe: Weeks 52, 68, 76, 84 and 100

Population: Analysis population is FAS3 which included all participants still on treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

ACR 50 response was defined as >=50% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=50% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=228 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=232 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=227 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved ACR 50 Response at Weeks 52, 68, 76, 84 and 100 Week 76	50.9 percentage of participants	56.0 percentage of participants	58.3 percentage of participants
Percentage of Participants Who Achieved ACR 50 Response at Weeks 52, 68, 76, 84 and 100 Week 52	44.3 percentage of participants	50.9 percentage of participants	49.6 percentage of participants
Percentage of Participants Who Achieved ACR 50 Response at Weeks 52, 68, 76, 84 and 100 Week 68	49.5 percentage of participants	60.8 percentage of participants	58.6 percentage of participants
Percentage of Participants Who Achieved ACR 50 Response at Weeks 52, 68, 76, 84 and 100 Week 84	56.3 percentage of participants	63.8 percentage of participants	57.8 percentage of participants
Percentage of Participants Who Achieved ACR 50 Response at Weeks 52, 68, 76, 84 and 100 Week 100	55.2 percentage of participants	60.7 percentage of participants	62.3 percentage of participants

SECONDARY outcome

Timeframe: Weeks 52, 68, 76, 84 and 100

Population: Analysis population is FAS3 which included all participants still on treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

ACR 70 response was defined as >=70% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=70% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=228 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=232 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=227 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved ACR 70 Response at Weeks 52, 68, 76, 84 and 100 Week 52	19.5 percentage of participants	29.7 percentage of participants	28.3 percentage of participants
Percentage of Participants Who Achieved ACR 70 Response at Weeks 52, 68, 76, 84 and 100 Week 68	27.8 percentage of participants	35.5 percentage of participants	36.1 percentage of participants
Percentage of Participants Who Achieved ACR 70 Response at Weeks 52, 68, 76, 84 and 100 Week 76	27.9 percentage of participants	36.4 percentage of participants	32.7 percentage of participants
Percentage of Participants Who Achieved ACR 70 Response at Weeks 52, 68, 76, 84 and 100 Week 84	29.6 percentage of participants	42.8 percentage of participants	39.4 percentage of participants
Percentage of Participants Who Achieved ACR 70 Response at Weeks 52, 68, 76, 84 and 100 Week 100	34.3 percentage of participants	39.3 percentage of participants	38.6 percentage of participants

SECONDARY outcome

Timeframe: Weeks 52, 68, 76, 84 and 100

Population: Analysis population is FAS3 which included all participants still on treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed for specified categories at specified timepoints.

ACR components include swollen joint count (66 joints), tender joint count (68 joints), patient's assessment of pain using visual analog scale (VAS; 0-10 cm, 0=no pain and 10=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-10 cm, 0=excellent and 10= poor), physician's global assessment of disease activity (VAS; 0-10 cm, 0=no arthritis activity and 10=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP (mg/dL).

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=228 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=232 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=227 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
ACR Components at Weeks 52, 68, 76, 84 and 100 Week 76: CRP	0.903 units on a scale Standard Deviation 1.4624	0.882 units on a scale Standard Deviation 1.2504	0.839 units on a scale Standard Deviation 1.1693
ACR Components at Weeks 52, 68, 76, 84 and 100 Week 52: Swollen Joint Count	2.1 units on a scale Standard Deviation 3.58	2.1 units on a scale Standard Deviation 4.18	2.5 units on a scale Standard Deviation 4.83
ACR Components at Weeks 52, 68, 76, 84 and 100 Week 68: Swollen Joint Count	1.6 units on a scale Standard Deviation 3.10	1.7 units on a scale Standard Deviation 3.87	2.0 units on a scale Standard Deviation 3.79
ACR Components at Weeks 52, 68, 76, 84 and 100 Week 76: Swollen Joint Count	1.6 units on a scale Standard Deviation 3.17	1.8 units on a scale Standard Deviation 3.72	2.3 units on a scale Standard Deviation 4.59
ACR Components at Weeks 52, 68, 76, 84 and 100 Week 84: Swollen Joint Count	1.6 units on a scale Standard Deviation 3.02	1.6 units on a scale Standard Deviation 3.82	2.0 units on a scale Standard Deviation 5.01
ACR Components at Weeks 52, 68, 76, 84 and 100 Week 100: Swollen Joint Count	1.8 units on a scale Standard Deviation 3.75	1.6 units on a scale Standard Deviation 3.99	2.0 units on a scale Standard Deviation 4.11
ACR Components at Weeks 52, 68, 76, 84 and 100 Week 52: Tender Joint Count	7.4 units on a scale Standard Deviation 10.30	6.3 units on a scale Standard Deviation 8.20	7.2 units on a scale Standard Deviation 9.49
ACR Components at Weeks 52, 68, 76, 84 and 100 Week 68: Tender Joint Count	6.0 units on a scale Standard Deviation 8.83	5.0 units on a scale Standard Deviation 6.83	6.3 units on a scale Standard Deviation 9.27
ACR Components at Weeks 52, 68, 76, 84 and 100 Week 76: Tender Joint Count	5.7 units on a scale Standard Deviation 8.31	5.2 units on a scale Standard Deviation 7.18	6.2 units on a scale Standard Deviation 8.90
ACR Components at Weeks 52, 68, 76, 84 and 100 Week 84: Tender Joint Count	5.1 units on a scale Standard Deviation 7.32	4.7 units on a scale Standard Deviation 7.20	5.9 units on a scale Standard Deviation 9.22
ACR Components at Weeks 52, 68, 76, 84 and 100 Week 100: Tender Joint Count	5.5 units on a scale Standard Deviation 8.44	4.7 units on a scale Standard Deviation 6.80	6.0 units on a scale Standard Deviation 8.90
ACR Components at Weeks 52, 68, 76, 84 and 100 Week 52: Patient's Assessment of Pain	3.53 units on a scale Standard Deviation 2.267	3.12 units on a scale Standard Deviation 2.335	3.17 units on a scale Standard Deviation 2.343
ACR Components at Weeks 52, 68, 76, 84 and 100 Week 68: Patient's Assessment of Pain	3.26 units on a scale Standard Deviation 2.313	2.68 units on a scale Standard Deviation 2.240	2.64 units on a scale Standard Deviation 2.105
ACR Components at Weeks 52, 68, 76, 84 and 100 Week 76: Patient's Assessment of Pain	3.17 units on a scale Standard Deviation 2.271	2.73 units on a scale Standard Deviation 2.217	2.70 units on a scale Standard Deviation 2.115
ACR Components at Weeks 52, 68, 76, 84 and 100 Week 84: Patient's Assessment of Pain	2.97 units on a scale Standard Deviation 2.150	2.67 units on a scale Standard Deviation 2.181	2.65 units on a scale Standard Deviation 2.217
ACR Components at Weeks 52, 68, 76, 84 and 100 Week 100: Patient's Assessment of Pain	2.90 units on a scale Standard Deviation 2.221	2.59 units on a scale Standard Deviation 2.290	2.57 units on a scale Standard Deviation 2.138
ACR Components at Weeks 52, 68, 76, 84 and 100 Week 52: PtGA of Disease Activity	3.68 units on a scale Standard Deviation 2.331	3.25 units on a scale Standard Deviation 2.380	3.24 units on a scale Standard Deviation 2.322
ACR Components at Weeks 52, 68, 76, 84 and 100 Week 68: PtGA of Disease Activity	3.50 units on a scale Standard Deviation 2.355	2.95 units on a scale Standard Deviation 2.282	2.85 units on a scale Standard Deviation 2.213
ACR Components at Weeks 52, 68, 76, 84 and 100 Week 76: PtGA of Disease Activity	3.25 units on a scale Standard Deviation 2.356	2.90 units on a scale Standard Deviation 2.273	2.95 units on a scale Standard Deviation 2.222
ACR Components at Weeks 52, 68, 76, 84 and 100 Week 84: PtGA of Disease Activity	3.09 units on a scale Standard Deviation 2.273	2.88 units on a scale Standard Deviation 2.252	2.83 units on a scale Standard Deviation 2.222
ACR Components at Weeks 52, 68, 76, 84 and 100 Week 100: PtGA of Disease Activity	3.15 units on a scale Standard Deviation 2.395	2.85 units on a scale Standard Deviation 2.378	2.60 units on a scale Standard Deviation 2.165
ACR Components at Weeks 52, 68, 76, 84 and 100 Week 52: PGA of Disease Activity	1.89 units on a scale Standard Deviation 1.654	1.78 units on a scale Standard Deviation 1.647	1.77 units on a scale Standard Deviation 1.617
ACR Components at Weeks 52, 68, 76, 84 and 100 Week 68: PGA of Disease Activity	1.63 units on a scale Standard Deviation 1.514	1.56 units on a scale Standard Deviation 1.538	1.61 units on a scale Standard Deviation 1.466
ACR Components at Weeks 52, 68, 76, 84 and 100 Week 76: PGA of Disease Activity	1.45 units on a scale Standard Deviation 1.469	1.67 units on a scale Standard Deviation 1.660	1.57 units on a scale Standard Deviation 1.524
ACR Components at Weeks 52, 68, 76, 84 and 100 Week 84: PGA of Disease Activity	1.55 units on a scale Standard Deviation 1.492	1.51 units on a scale Standard Deviation 1.619	1.50 units on a scale Standard Deviation 1.558
ACR Components at Weeks 52, 68, 76, 84 and 100 Week 100: PGA of Disease Activity	1.39 units on a scale Standard Deviation 1.510	1.49 units on a scale Standard Deviation 1.581	1.41 units on a scale Standard Deviation 1.405
ACR Components at Weeks 52, 68, 76, 84 and 100 Week 52: HAQ-DI score	0.9073 units on a scale Standard Deviation 0.63812	0.7942 units on a scale Standard Deviation 0.59711	0.7317 units on a scale Standard Deviation 0.58430
ACR Components at Weeks 52, 68, 76, 84 and 100 Week 68: HAQ-DI score	0.8425 units on a scale Standard Deviation 0.61757	0.7625 units on a scale Standard Deviation 0.59524	0.6836 units on a scale Standard Deviation 0.56049
ACR Components at Weeks 52, 68, 76, 84 and 100 Week 76: HAQ-DI score	0.8311 units on a scale Standard Deviation 0.62101	0.6978 units on a scale Standard Deviation 0.56588	0.6996 units on a scale Standard Deviation 0.55988
ACR Components at Weeks 52, 68, 76, 84 and 100 Week 84: HAQ-DI score	0.8076 units on a scale Standard Deviation 0.62465	0.7134 units on a scale Standard Deviation 0.59528	0.6775 units on a scale Standard Deviation 0.58870
ACR Components at Weeks 52, 68, 76, 84 and 100 Week 100: HAQ-DI score	0.7692 units on a scale Standard Deviation 0.59960	0.6747 units on a scale Standard Deviation 0.57213	0.6420 units on a scale Standard Deviation 0.56838
ACR Components at Weeks 52, 68, 76, 84 and 100 Week 52: CRP	0.904 units on a scale Standard Deviation 1.6039	0.930 units on a scale Standard Deviation 1.2443	0.886 units on a scale Standard Deviation 1.2366
ACR Components at Weeks 52, 68, 76, 84 and 100 Week 68: CRP	0.861 units on a scale Standard Deviation 1.1586	0.884 units on a scale Standard Deviation 1.3520	0.796 units on a scale Standard Deviation 1.1109
ACR Components at Weeks 52, 68, 76, 84 and 100 Week 84: CRP	0.898 units on a scale Standard Deviation 1.3229	0.856 units on a scale Standard Deviation 1.1926	0.872 units on a scale Standard Deviation 1.3239
ACR Components at Weeks 52, 68, 76, 84 and 100 Week 100: CRP	0.880 units on a scale Standard Deviation 1.3415	0.826 units on a scale Standard Deviation 1.2277	0.820 units on a scale Standard Deviation 1.1227

SECONDARY outcome

Timeframe: Baseline, Weeks 52, 68, 76, 84 and 100

Population: Analysis population is FAS3 which included all participants still on treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed for specified categories at specified timepoints.

ACR components include swollen joint count (66 joints), tender joint count (68 joints), patient's assessment of pain using visual analog scale (VAS; 0-10 cm, 0=no pain and 10=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-10 cm, 0=excellent and 10= poor), physician's global assessment of disease activity (VAS; 0-10 cm, 0=no arthritis activity and 10=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP (mg/dL).

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=228 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=232 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=227 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 68: PtGA of Disease Activity	-3.08 units on a scale Standard Deviation 2.786	-3.58 units on a scale Standard Deviation 2.446	-3.49 units on a scale Standard Deviation 2.500
Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 76: PtGA of Disease Activity	-3.32 units on a scale Standard Deviation 2.860	-3.63 units on a scale Standard Deviation 2.512	-3.38 units on a scale Standard Deviation 2.501
Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 84: PtGA of Disease Activity	-3.46 units on a scale Standard Deviation 2.752	-3.67 units on a scale Standard Deviation 2.572	-3.50 units on a scale Standard Deviation 2.579
Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 100: PtGA of Disease Activity	-3.40 units on a scale Standard Deviation 2.846	-3.67 units on a scale Standard Deviation 2.612	-3.73 units on a scale Standard Deviation 2.493
Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 52: PGA of Disease Activity	-4.79 units on a scale Standard Deviation 1.992	-4.77 units on a scale Standard Deviation 2.001	-4.82 units on a scale Standard Deviation 2.117
Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 68: PGA of Disease Activity	-5.06 units on a scale Standard Deviation 2.037	-4.98 units on a scale Standard Deviation 1.992	-5.01 units on a scale Standard Deviation 2.105
Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 76: PGA of Disease Activity	-5.23 units on a scale Standard Deviation 1.995	-4.86 units on a scale Standard Deviation 2.044	-5.03 units on a scale Standard Deviation 2.078
Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 84: PGA of Disease Activity	-5.13 units on a scale Standard Deviation 2.040	-5.06 units on a scale Standard Deviation 2.074	-5.09 units on a scale Standard Deviation 2.142
Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 100: PGA of Disease Activity	-5.26 units on a scale Standard Deviation 2.098	-5.05 units on a scale Standard Deviation 2.011	-5.18 units on a scale Standard Deviation 2.044
Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 76: HAQ-DI score	-0.4740 units on a scale Standard Deviation 0.57852	-0.5694 units on a scale Standard Deviation 0.56421	-0.5448 units on a scale Standard Deviation 0.54739
Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 84: HAQ-DI score	-0.5041 units on a scale Standard Deviation 0.59716	-0.5653 units on a scale Standard Deviation 0.59488	-0.5656 units on a scale Standard Deviation 0.57921
Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 100: HAQ-DI score	-0.5356 units on a scale Standard Deviation 0.56707	-0.5859 units on a scale Standard Deviation 0.58199	-0.6000 units on a scale Standard Deviation 0.56858
Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 52: CRP	-1.262 units on a scale Standard Deviation 2.8315	-1.021 units on a scale Standard Deviation 2.2301	-0.959 units on a scale Standard Deviation 2.4188
Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 68: CRP	-1.212 units on a scale Standard Deviation 2.3061	-1.081 units on a scale Standard Deviation 2.1585	-1.060 units on a scale Standard Deviation 2.3334
Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 76: CRP	-1.283 units on a scale Standard Deviation 2.8163	-1.098 units on a scale Standard Deviation 2.3654	-1.017 units on a scale Standard Deviation 2.2801
Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 84: CRP	-1.230 units on a scale Standard Deviation 2.4262	-1.101 units on a scale Standard Deviation 2.1216	-0.940 units on a scale Standard Deviation 2.3781
Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 100: CRP	-1.244 units on a scale Standard Deviation 2.5828	-1.129 units on a scale Standard Deviation 2.2261	-1.042 units on a scale Standard Deviation 2.0600
Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 76: Swollen Joint Count	-10.7 units on a scale Standard Deviation 5.98	-10.0 units on a scale Standard Deviation 6.33	-10.7 units on a scale Standard Deviation 6.18
Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 52: Swollen Joint Count	-10.2 units on a scale Standard Deviation 6.72	-9.6 units on a scale Standard Deviation 6.30	-10.4 units on a scale Standard Deviation 6.16
Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 68: Swollen Joint Count	-10.7 units on a scale Standard Deviation 6.76	-10.0 units on a scale Standard Deviation 6.50	-10.9 units on a scale Standard Deviation 7.22
Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 84: Swollen Joint Count	-10.6 units on a scale Standard Deviation 6.06	-10.1 units on a scale Standard Deviation 6.34	-10.7 units on a scale Standard Deviation 7.08
Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 100: Swollen Joint Count	-10.6 units on a scale Standard Deviation 6.15	-10.2 units on a scale Standard Deviation 6.88	-10.8 units on a scale Standard Deviation 6.66
Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 52: Tender Joint Count	-14.1 units on a scale Standard Deviation 11.38	-13.5 units on a scale Standard Deviation 10.04	-15.2 units on a scale Standard Deviation 10.45
Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 68: Tender Joint Count	-15.7 units on a scale Standard Deviation 10.94	-14.8 units on a scale Standard Deviation 10.15	-16.0 units on a scale Standard Deviation 11.02
Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 76: Tender Joint Count	-16.1 units on a scale Standard Deviation 10.97	-14.7 units on a scale Standard Deviation 10.22	-16.1 units on a scale Standard Deviation 10.91
Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 84: Tender Joint Count	-16.6 units on a scale Standard Deviation 11.33	-15.3 units on a scale Standard Deviation 10.50	-16.0 units on a scale Standard Deviation 11.22
Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 100: Tender Joint Count	-16.3 units on a scale Standard Deviation 11.27	-15.3 units on a scale Standard Deviation 11.10	-16.4 units on a scale Standard Deviation 10.70
Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 52: Patient's Assessment of Pain	-2.78 units on a scale Standard Deviation 2.645	-3.20 units on a scale Standard Deviation 2.557	-2.92 units on a scale Standard Deviation 2.686
Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 68: Patient's Assessment of Pain	-3.10 units on a scale Standard Deviation 2.707	-3.62 units on a scale Standard Deviation 2.530	-3.46 units on a scale Standard Deviation 2.574
Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 76: Patient's Assessment of Pain	-3.18 units on a scale Standard Deviation 2.724	-3.57 units on a scale Standard Deviation 2.566	-3.38 units on a scale Standard Deviation 2.620
Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 84: Patient's Assessment of Pain	-3.35 units on a scale Standard Deviation 2.595	-3.64 units on a scale Standard Deviation 2.568	-3.42 units on a scale Standard Deviation 2.669
Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 100: Patient's Assessment of Pain	-3.41 units on a scale Standard Deviation 2.578	-3.69 units on a scale Standard Deviation 2.625	-3.52 units on a scale Standard Deviation 2.615
Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 52: PtGA of Disease Activity	-2.87 units on a scale Standard Deviation 2.761	-3.29 units on a scale Standard Deviation 2.553	-3.09 units on a scale Standard Deviation 2.523
Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 52: HAQ-DI score	-0.3899 units on a scale Standard Deviation 0.58250	-0.4801 units on a scale Standard Deviation 0.56246	-0.5111 units on a scale Standard Deviation 0.58347
Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 68: HAQ-DI score	-0.4668 units on a scale Standard Deviation 0.59226	-0.5120 units on a scale Standard Deviation 0.54928	-0.5631 units on a scale Standard Deviation 0.54528

SECONDARY outcome

Timeframe: Baseline, Weeks 52, 68, 76, 84 and 100

Population: Analysis population is FAS3 which included all participants still on treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed for specified categories at specified timepoints.

ACR components include swollen joint count (66 joints), tender joint count (68 joints), patient's assessment of pain using visual analog scale (VAS; 0-10 cm, 0=no pain and 10=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-10 cm, 0=excellent and 10= poor), physician's global assessment of disease activity (VAS; 0-10 cm, 0=no arthritis activity and 10=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP (mg/dL).

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=228 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=232 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=227 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 76: Swollen Joint Count	-87.98 percent change Standard Deviation 20.617	-86.05 percent change Standard Deviation 21.096	-85.82 percent change Standard Deviation 22.291
Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 84: Swollen Joint Count	-87.72 percent change Standard Deviation 22.243	-87.68 percent change Standard Deviation 23.304	-87.16 percent change Standard Deviation 24.888
Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 100: Swollen Joint Count	-87.61 percent change Standard Deviation 21.214	-86.19 percent change Standard Deviation 40.865	-86.31 percent change Standard Deviation 24.106
Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 52: Tender Joint Count	-67.29 percent change Standard Deviation 35.725	-70.18 percent change Standard Deviation 32.062	-70.54 percent change Standard Deviation 31.311
Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 68: Tender Joint Count	-74.28 percent change Standard Deviation 29.764	-75.63 percent change Standard Deviation 29.437	-74.40 percent change Standard Deviation 29.760
Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 76: Tender Joint Count	-75.71 percent change Standard Deviation 27.653	-74.71 percent change Standard Deviation 29.728	-75.11 percent change Standard Deviation 28.559
Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 84: Tender Joint Count	-77.21 percent change Standard Deviation 27.045	-78.01 percent change Standard Deviation 26.112	-75.45 percent change Standard Deviation 32.489
Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 52: Patient's Assessment of Pain	-39.52 percent change Standard Deviation 44.939	-48.81 percent change Standard Deviation 39.191	-43.86 percent change Standard Deviation 45.891
Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 68: Patient's Assessment of Pain	-44.91 percent change Standard Deviation 44.371	-55.77 percent change Standard Deviation 38.780	-52.43 percent change Standard Deviation 41.186
Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 76: Patient's Assessment of Pain	-46.02 percent change Standard Deviation 44.989	-54.38 percent change Standard Deviation 39.135	-51.34 percent change Standard Deviation 41.903
Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 84: Patient's Assessment of Pain	-49.64 percent change Standard Deviation 40.991	-55.28 percent change Standard Deviation 40.388	-52.59 percent change Standard Deviation 43.131
Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 100: Patient's Assessment of Pain	-50.82 percent change Standard Deviation 42.970	-56.36 percent change Standard Deviation 41.310	-54.27 percent change Standard Deviation 40.819
Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 84: PtGA of Disease Activity	-49.38 percent change Standard Deviation 42.315	-54.17 percent change Standard Deviation 37.132	-51.86 percent change Standard Deviation 44.532
Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 52: Swollen Joint Count	-82.64 percent change Standard Deviation 30.161	-83.03 percent change Standard Deviation 30.210	-84.27 percent change Standard Deviation 23.698
Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 68: Swollen Joint Count	-87.41 percent change Standard Deviation 24.049	-86.08 percent change Standard Deviation 29.764	-86.41 percent change Standard Deviation 22.642
Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 100: Tender Joint Count	-77.04 percent change Standard Deviation 27.510	-75.96 percent change Standard Deviation 32.600	-76.21 percent change Standard Deviation 27.345
Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 52: PtGA of Disease Activity	-39.70 percent change Standard Deviation 44.981	-48.48 percent change Standard Deviation 38.982	-46.07 percent change Standard Deviation 40.614
Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 68: PtGA of Disease Activity	-42.93 percent change Standard Deviation 44.220	-53.84 percent change Standard Deviation 35.096	-52.47 percent change Standard Deviation 38.155
Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 76: PtGA of Disease Activity	-46.42 percent change Standard Deviation 45.106	-54.41 percent change Standard Deviation 35.276	-50.66 percent change Standard Deviation 40.992
Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 52: PGA of Disease Activity	-71.24 percent change Standard Deviation 24.771	-72.95 percent change Standard Deviation 24.168	-72.58 percent change Standard Deviation 24.579
Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 100: PtGA of Disease Activity	-48.17 percent change Standard Deviation 44.804	-55.08 percent change Standard Deviation 37.052	-57.09 percent change Standard Deviation 34.970
Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 68: PGA of Disease Activity	-74.76 percent change Standard Deviation 23.290	-76.00 percent change Standard Deviation 22.550	-74.48 percent change Standard Deviation 26.280
Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 76: PGA of Disease Activity	-77.68 percent change Standard Deviation 23.015	-74.42 percent change Standard Deviation 25.014	-75.56 percent change Standard Deviation 23.613
Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 52: HAQ-DI score	-27.27 percent change Standard Deviation 54.587	-33.28 percent change Standard Deviation 64.067	-35.17 percent change Standard Deviation 66.105
Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 84: PGA of Disease Activity	-75.77 percent change Standard Deviation 23.674	-76.77 percent change Standard Deviation 24.433	-76.49 percent change Standard Deviation 24.355
Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 100: PGA of Disease Activity	-78.11 percent change Standard Deviation 24.049	-77.15 percent change Standard Deviation 23.217	-77.82 percent change Standard Deviation 22.733
Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 68: HAQ-DI score	-33.34 percent change Standard Deviation 49.027	-37.47 percent change Standard Deviation 57.370	-44.33 percent change Standard Deviation 44.064
Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 76: HAQ-DI score	-34.38 percent change Standard Deviation 47.311	-40.08 percent change Standard Deviation 58.932	-41.84 percent change Standard Deviation 47.877
Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 84: HAQ-DI score	-36.73 percent change Standard Deviation 47.541	-40.10 percent change Standard Deviation 58.703	-43.18 percent change Standard Deviation 52.116
Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 100: HAQ-DI score	-40.36 percent change Standard Deviation 44.407	-42.84 percent change Standard Deviation 54.187	-47.54 percent change Standard Deviation 47.265
Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 52: CRP	-2.67 percent change Standard Deviation 205.761	-23.41 percent change Standard Deviation 104.622	-1.34 percent change Standard Deviation 194.673
Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 68: CRP	-1.68 percent change Standard Deviation 330.574	-28.38 percent change Standard Deviation 138.159	-13.91 percent change Standard Deviation 174.522
Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 76: CRP	-10.76 percent change Standard Deviation 226.332	7.85 percent change Standard Deviation 502.170	-24.22 percent change Standard Deviation 110.486
Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 84: CRP	-0.72 percent change Standard Deviation 387.986	-26.87 percent change Standard Deviation 114.471	-19.89 percent change Standard Deviation 131.695
Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 Week 100: CRP	-4.33 percent change Standard Deviation 196.246	-23.99 percent change Standard Deviation 150.816	-14.35 percent change Standard Deviation 171.666

SECONDARY outcome

Timeframe: Week 100

Population: FAS3 among participants who achieved ACR20 response at Week 52.

ACR 20 response was defined as >=20% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=20% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=147 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=178 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=171 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Maintained an ACR 20 Response at Week 100 Among Participants Who Achieved an ACR 20 Response at Week 52	94.6 percentage of participants	90.4 percentage of participants	93.0 percentage of participants

SECONDARY outcome

Timeframe: Week 100

Population: FAS3 among participants who achieved ACR50 response at Week 52.

ACR 50 response was defined as >=50% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=50% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=96 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=116 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=111 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Maintained an ACR 50 Response at Week 100 Among Participants Who Achieved an ACR 50 Response at Week 52	81.3 percentage of participants	81.9 percentage of participants	83.8 percentage of participants

SECONDARY outcome

Timeframe: Week 100

Population: FAS3 among participants who achieved ACR70 response at Week 52.

ACR 70 response was defined as >=70% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=70% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 millimeters [mm], 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=43 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=68 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=64 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Maintained an ACR 70 Response at Week 100 Among Participants Who Achieved an ACR 70 Response at Week 52	65.1 percentage of participants	80.9 percentage of participants	71.9 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 52, 68, 76, 84 and 100

Population: Analysis population is FAS3 which included all participants still on treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

HAQ-DI score assess functional status of participant. It is 20 question instrument that assess degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0=indicating no difficulty, to 3=indicating inability to perform a task in that area. Total HAQ score is average of the computed categories scores ranging from 0-3, where 0=least difficulty and 3=extreme difficulty. Lower scores are indicative of better functioning. Negative change from baseline indicates improvement of physical function.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=228 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=232 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=227 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100 Week 52	-0.3899 units on a scale Standard Deviation 0.58250	-0.4801 units on a scale Standard Deviation 0.56246	-0.5111 units on a scale Standard Deviation 0.58347
Change From Baseline in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100 Week 68	-0.4668 units on a scale Standard Deviation 0.59226	-0.5120 units on a scale Standard Deviation 0.54928	-0.5631 units on a scale Standard Deviation 0.54528
Change From Baseline in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100 Week 76	-0.4740 units on a scale Standard Deviation 0.57852	-0.5694 units on a scale Standard Deviation 0.56421	-0.5448 units on a scale Standard Deviation 0.54739
Change From Baseline in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100 Week 84	-0.5041 units on a scale Standard Deviation 0.59716	-0.5653 units on a scale Standard Deviation 0.59488	-0.5656 units on a scale Standard Deviation 0.57921
Change From Baseline in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100 Week 100	-0.5356 units on a scale Standard Deviation 0.56707	-0.5859 units on a scale Standard Deviation 0.58199	-0.6000 units on a scale Standard Deviation 0.56858

SECONDARY outcome

Timeframe: Weeks 52, 68, 76, 84 and 100

Population: Analysis population is FAS3 among participants with HAQ-DI score \>=0.35 at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

HAQ-DI score assess functional status of participant. It is 20 question instrument that assess degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0=indicating no difficulty, to 3=indicating inability to perform a task in that area. Total HAQ score is average of the computed categories scores ranging from 0-3, where 0=least difficulty and 3=extreme difficulty. Lower scores are indicative of better functioning and a decrease of 0.35 from baseline in HAQ-DI score indicates a meaningful improvement.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=219 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=213 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=211 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved a Clinically Meaningful Improvement (>=0.35 Improvement From Baseline) in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100 Among Participants With HAQ-DI Score >=0.35 at Baseline Week 52	51.1 percentage of participants	60.6 percentage of participants	63.3 percentage of participants
Percentage of Participants Who Achieved a Clinically Meaningful Improvement (>=0.35 Improvement From Baseline) in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100 Among Participants With HAQ-DI Score >=0.35 at Baseline Week 68	57.2 percentage of participants	64.9 percentage of participants	69.4 percentage of participants
Percentage of Participants Who Achieved a Clinically Meaningful Improvement (>=0.35 Improvement From Baseline) in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100 Among Participants With HAQ-DI Score >=0.35 at Baseline Week 76	59.3 percentage of participants	68.4 percentage of participants	64.7 percentage of participants
Percentage of Participants Who Achieved a Clinically Meaningful Improvement (>=0.35 Improvement From Baseline) in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100 Among Participants With HAQ-DI Score >=0.35 at Baseline Week 84	58.9 percentage of participants	66.8 percentage of participants	65.5 percentage of participants
Percentage of Participants Who Achieved a Clinically Meaningful Improvement (>=0.35 Improvement From Baseline) in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100 Among Participants With HAQ-DI Score >=0.35 at Baseline Week 100	63.3 percentage of participants	70.7 percentage of participants	70.1 percentage of participants

SECONDARY outcome

Timeframe: Week 100

Population: Analysis population is FAS3 among participants with HAQ-DI Score \>=0.35 at Baseline and who achieved a HAQ-DI response at Week 52. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

HAQ-DI score assess functional status of participant. It is 20 question instrument that assess degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0=indicating no difficulty, to 3=indicating inability to perform a task in that area. Total HAQ score is average of the computed categories scores ranging from 0-3, where 0=least difficulty and 3=extreme difficulty. Lower scores are indicative of better functioning and a decrease of 0.35 from baseline in HAQ-DI score indicates a meaningful improvement.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=107 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=125 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=131 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Maintained a HAQ-DI Response (>=0.35 Improvement From Baseline in HAQ-DI Score) at Week 100 Among Participants Who Achieved a HAQ-DI Response at Week 52	91.6 percentage of participants	90.4 percentage of participants	88.5 percentage of participants

SECONDARY outcome

Timeframe: Weeks 52, 68, 76, 84 and 100

Population: Analysis population is FAS3 which included all participants still on treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

DAS28 based on CRP is an index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. DAS28 (CRP) response criteria was defined as follows: Good response: <=3.2 at visit and >1.2 improvement; Moderate response: >3.2 at visit and >1.2 improvement or <=5.1 at visit and >0.6-1.2 improvement; No response: <=0.6 improvement, or >5.1 at visit and <=1.2 improvement. The values are 0=best to 10=worst. A DAS28 (CRP) responder was defined as achieving a good or moderate DAS28 response at a specific visit.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=228 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=232 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=227 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 52, 68, 76, 84 and 100 Week 52	89.3 percentage of participants	89.7 percentage of participants	90.2 percentage of participants
Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 52, 68, 76, 84 and 100 Week 68	92.7 percentage of participants	92.5 percentage of participants	92.7 percentage of participants
Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 52, 68, 76, 84 and 100 Week 76	94.1 percentage of participants	90.2 percentage of participants	93.3 percentage of participants
Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 52, 68, 76, 84 and 100 Week 84	94.8 percentage of participants	92.7 percentage of participants	92.5 percentage of participants
Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 52, 68, 76, 84 and 100 Week 100	94.3 percentage of participants	90.6 percentage of participants	92.7 percentage of participants

SECONDARY outcome

Timeframe: Weeks 52, 68, 76, 84 and 100

Population: Analysis population is FAS3 which included all participants still on treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

DAS28 based on CRP is an index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. DAS28 (CRP) remission was defined as DAS28 (CRP) value <2.6 at the analysis visit.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=228 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=232 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=227 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 52, 68, 76, 84 and 100 Week 52	34.7 percentage of participants	39.7 percentage of participants	40.4 percentage of participants
Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 52, 68, 76, 84 and 100 Week 68	39.0 percentage of participants	44.9 percentage of participants	49.1 percentage of participants
Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 52, 68, 76, 84 and 100 Week 76	43.2 percentage of participants	44.2 percentage of participants	43.5 percentage of participants
Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 52, 68, 76, 84 and 100 Week 84	41.8 percentage of participants	50.9 percentage of participants	48.1 percentage of participants
Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 52, 68, 76, 84 and 100 Week 100	42.4 percentage of participants	47.5 percentage of participants	51.6 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 52, 68, 76, 84 and 100

Population: Analysis population is FAS3 which included all participants still on treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

DAS28 based on CRP is an index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. Negative changes from baseline indicate improvement of arthritis.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=228 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=232 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=227 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in DAS28 (CRP) Score at Weeks 52, 68, 76, 84 and 100 Week 52	-2.14 units on a scale Standard Deviation 1.142	-2.08 units on a scale Standard Deviation 1.124	-2.14 units on a scale Standard Deviation 1.118
Change From Baseline in DAS28 (CRP) Score at Weeks 52, 68, 76, 84 and 100 Week 68	-2.29 units on a scale Standard Deviation 1.132	-2.25 units on a scale Standard Deviation 1.170	-2.30 units on a scale Standard Deviation 1.143
Change From Baseline in DAS28 (CRP) Score at Weeks 52, 68, 76, 84 and 100 Week 76	-2.35 units on a scale Standard Deviation 1.110	-2.24 units on a scale Standard Deviation 1.147	-2.24 units on a scale Standard Deviation 1.087
Change From Baseline in DAS28 (CRP) Score at Weeks 52, 68, 76, 84 and 100 Week 84	-2.40 units on a scale Standard Deviation 1.087	-2.35 units on a scale Standard Deviation 1.181	-2.31 units on a scale Standard Deviation 1.156
Change From Baseline in DAS28 (CRP) Score at Weeks 52, 68, 76, 84 and 100 Week 100	-2.42 units on a scale Standard Deviation 1.144	-2.37 units on a scale Standard Deviation 1.215	-2.36 units on a scale Standard Deviation 1.120

SECONDARY outcome

Timeframe: Weeks 52, 68, 76, 84 and 100

Population: Analysis population is FAS3 which included all participants still on treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

The modified PsARC response was defined as improvement in at least 2 of the four criteria: >=30% decrease in swollen joint count, >=30% decrease in tender joint count, >=20% improvement in patient's Global Assessment of Disease Activity (arthritis) on a VAS (0-100 mm, 0=excellent and 100= poor), >=20% improvement in physician's Global Assessment of Disease Activity using VAS (VAS: 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), and at least one of the 2 joint criteria with no deterioration in the other criteria.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=228 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=232 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=227 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 52, 68, 76, 84 and 100 Week 52	81.4 percentage of participants	86.2 percentage of participants	83.6 percentage of participants
Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 52, 68, 76, 84 and 100 Week 68	84.3 percentage of participants	89.9 percentage of participants	87.6 percentage of participants
Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 52, 68, 76, 84 and 100 Week 76	84.6 percentage of participants	88.8 percentage of participants	90.6 percentage of participants
Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 52, 68, 76, 84 and 100 Week 84	87.4 percentage of participants	87.7 percentage of participants	87.6 percentage of participants
Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 52, 68, 76, 84 and 100 Week 100	86.3 percentage of participants	89.3 percentage of participants	88.6 percentage of participants

SECONDARY outcome

Timeframe: Weeks 52, 76, and 100

Population: Analysis population is FAS3 among the participants with enthesitis (LEI) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Enthesitis was assessed using the LEI, a tool developed to assess enthesitis in participants with PsA and evaluates the presence (score of 1) or absence (score of 0) of pain by applying local pressure to the following entheses: left and right lateral epicondyle humerus, left and right medial femoral condyle, and left and right achilles tendon insertion. The enthesitis index score is a total score of the 6 evaluated sites from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). A LEI score of 0 at a post baseline visit indicates resolution of enthesitis when baseline LEI>0.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=165 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=147 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=160 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants With Resolution of Enthesitis (LEI) at Weeks 52, 76 and 100 Among the Participants With Enthesitis (LEI) at Baseline Week 52	67.3 percentage of participants	66.0 percentage of participants	61.0 percentage of participants
Percentage of Participants With Resolution of Enthesitis (LEI) at Weeks 52, 76 and 100 Among the Participants With Enthesitis (LEI) at Baseline Week 76	72.3 percentage of participants	71.8 percentage of participants	67.5 percentage of participants
Percentage of Participants With Resolution of Enthesitis (LEI) at Weeks 52, 76 and 100 Among the Participants With Enthesitis (LEI) at Baseline Week 100	75.2 percentage of participants	77.5 percentage of participants	67.7 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 52, 76 and 100

Population: Analysis population is FAS3 among the participants with enthesitis (LEI) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Enthesitis was assessed using the LEI, a tool developed to assess enthesitis in participants with PsA and evaluates the presence (score of 1) or absence (score of 0) of pain by applying local pressure to the following entheses: left and right lateral epicondyle humerus, left and right medial femoral condyle, and left and right achilles tendon insertion. The enthesitis index score is a total score of the 6 evaluated sites from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). Negative changes from baseline indicate improvement of enthesitis.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=165 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=147 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=160 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 52, 76 and 100 Among the Participants With Enthesitis at Baseline Week 52	-2.1 units on a scale Standard Deviation 1.59	-1.9 units on a scale Standard Deviation 1.66	-2.1 units on a scale Standard Deviation 1.72
Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 52, 76 and 100 Among the Participants With Enthesitis at Baseline Week 76	-2.3 units on a scale Standard Deviation 1.52	-2.1 units on a scale Standard Deviation 1.66	-2.2 units on a scale Standard Deviation 1.69
Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 52, 76 and 100 Among the Participants With Enthesitis at Baseline Week 100	-2.4 units on a scale Standard Deviation 1.70	-2.1 units on a scale Standard Deviation 1.65	-2.2 units on a scale Standard Deviation 1.80

SECONDARY outcome

Timeframe: Weeks 52, 76 and 100

Population: Analysis population is FAS3 among participants with dactylitis at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

The presence and severity of dactylitis was assessed in both hands and feet using a scoring system from 0 to 3 (0-no dactylitis, 1-mild dactylitis, 2-moderate dactylitis, and 3-severe dactylitis) for each digit. The results were summed to produce a final score ranging from 0 to 60. Higher score indicates more severe dactylitis. Resolution of dactylitis was defined as a dactylitis score of 0 with the baseline dactylitis score >0.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=92 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=104 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=110 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants With Resolution of Dactylitis at Weeks 52, 76 and 100 Among Participants With Dactylitis at Baseline Week 52	78.3 percentage of participants	81.7 percentage of participants	80.7 percentage of participants
Percentage of Participants With Resolution of Dactylitis at Weeks 52, 76 and 100 Among Participants With Dactylitis at Baseline Week 76	80.2 percentage of participants	84.0 percentage of participants	82.4 percentage of participants
Percentage of Participants With Resolution of Dactylitis at Weeks 52, 76 and 100 Among Participants With Dactylitis at Baseline Week 100	83.7 percentage of participants	91.1 percentage of participants	82.9 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 52, 76 and 100

Population: Analysis population is FAS3 among the participants with dactylitis at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

The presence and severity of dactylitis was assessed in both hands and feet using a scoring system from 0 to 3 (0-no dactylitis, 1-mild dactylitis, 2-moderate dactylitis, and 3-severe dactylitis) for each digit. The results were summed to produce a final score ranging from 0 to 60. Higher score indicates more severe dactylitis. Negative changes from baseline indicate improvement of dactylitis.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=92 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=104 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=110 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in Dactylitis Scores at Weeks 52, 76 and 100 Among the Participants With Dactylitis at Baseline Week 52	-7.4 units on a scale Standard Deviation 9.22	-7.3 units on a scale Standard Deviation 9.78	-7.4 units on a scale Standard Deviation 8.66
Change From Baseline in Dactylitis Scores at Weeks 52, 76 and 100 Among the Participants With Dactylitis at Baseline Week 76	-8.0 units on a scale Standard Deviation 9.55	-7.8 units on a scale Standard Deviation 10.24	-7.6 units on a scale Standard Deviation 8.93
Change From Baseline in Dactylitis Scores at Weeks 52, 76 and 100 Among the Participants With Dactylitis at Baseline Week 100	-8.1 units on a scale Standard Deviation 9.63	-7.9 units on a scale Standard Deviation 10.12	-7.9 units on a scale Standard Deviation 9.14

SECONDARY outcome

Timeframe: Baseline, Weeks 52, 76 and 100

Population: Analysis population is FAS3 which included all participants still on treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

PASDAS (score range of 0 to 10, where higher score indicated more severe disease) is a composite score of overall disease activity combining Patient's Global Assessment of Disease Activity (arthritis and psoriasis, using VAS [0-100 mm, 0=excellent and 100= poor), Physician's Global Assessment of Disease Activity (using VAS [0-100 mm, 0=no arthritis activity and 100=extremely active arthritis]), swollen joint count (0-66 joints), tender joint count (0-68 joints), CRP (mg/L), enthesitis based on LEI (0= 0 sites with tenderness to 6= worst possible score; 6 sites with tenderness), tender dactylitis count (scoring each digit from 0-3 [where 0= no tenderness and 3= extreme tenderness] and recoding to 0-1, where any score > 0 equaled 1), and the PCS score with score range 0-100 (higher score-better quality of life) of the SF-36 health survey. The cutoffs for disease activity were 3.2 (low) to 5.4 (high). Negative changes from baseline indicate improvement of overall disease activity.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=228 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=232 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=227 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in PASDAS Score at Weeks 52, 76 and 100 Week 52	-3.054 units on a scale Standard Deviation 1.4954	-3.189 units on a scale Standard Deviation 1.5216	-3.184 units on a scale Standard Deviation 1.4576
Change From Baseline in PASDAS Score at Weeks 52, 76 and 100 Week 76	-3.503 units on a scale Standard Deviation 1.4708	-3.418 units on a scale Standard Deviation 1.5646	-3.436 units on a scale Standard Deviation 1.4428
Change From Baseline in PASDAS Score at Weeks 52, 76 and 100 Week 100	-3.574 units on a scale Standard Deviation 1.4785	-3.586 units on a scale Standard Deviation 1.5425	-3.549 units on a scale Standard Deviation 1.4635

SECONDARY outcome

Timeframe: Weeks 52, 76 and 100

Population: Analysis population is FAS3. Here, n (number analyzed) signifies the number of participants analyzed for specified categories at specified timepoints.

PASDAS (score range of 0 to 10, where higher score indicated more severe disease) is a composite score of overall disease activity combining PtGA of Disease Activity (arthritis and psoriasis, using VAS [0-100 mm, 0=excellent and 100= poor), PGA of Disease Activity (using VAS [0-100 mm, 0=no arthritis activity and 100=extremely active arthritis]), swollen joint count (0-66 joints), tender joint count (0-68 joints), CRP (mg/L), enthesitis based on LEI (0= 0 sites with tenderness to 6= worst possible score; 6 sites with tenderness), tender dactylitis count (scoring each digit from 0-3 [where 0= no tenderness and 3= extreme tenderness] and recoding to 0-1, where any score > 0 equaled 1), and the PCS score with score range 0-100 (higher score-better quality of life) of the SF-36 health survey. The cutoffs for disease activity were 3.2 (low) to 5.4 (high). Negative changes from baseline indicate improvement of overall disease activity. Low: PASDAS <= 3.2; Very low: PASDAS <= 1.9.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=228 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=232 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=227 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants With Low or Very Low Disease Activity Based on PASDAS at Weeks 52, 76 and 100 Week 52: Low	39.0 percentage of participants	44.8 percentage of participants	46.7 percentage of participants
Percentage of Participants With Low or Very Low Disease Activity Based on PASDAS at Weeks 52, 76 and 100 Week 52: Very Low	13.0 percentage of participants	22.0 percentage of participants	16.0 percentage of participants
Percentage of Participants With Low or Very Low Disease Activity Based on PASDAS at Weeks 52, 76 and 100 Week 76: Low	52.1 percentage of participants	50.0 percentage of participants	49.8 percentage of participants
Percentage of Participants With Low or Very Low Disease Activity Based on PASDAS at Weeks 52, 76 and 100 Week 76: Very Low	18.3 percentage of participants	23.4 percentage of participants	22.0 percentage of participants
Percentage of Participants With Low or Very Low Disease Activity Based on PASDAS at Weeks 52, 76 and 100 Week 100: Low	55.3 percentage of participants	54.7 percentage of participants	57.8 percentage of participants
Percentage of Participants With Low or Very Low Disease Activity Based on PASDAS at Weeks 52, 76 and 100 Week 100: Very Low	19.9 percentage of participants	26.0 percentage of participants	23.4 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 52, 76 and 100

Population: Analysis population is FAS3 which included all participants still on treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

GRACE index is a composite PsA disease activity score converted from Arithmetic Mean of Desirability Function (AMDF), derived from TJC (0-68) and SJC (0-66), HAQ-DI (0-3), patient's global assessment of disease activity on arthritis and psoriasis (0-100 mm, 0=excellent and 100=poor), patient's assessment of skin disease activity (0-100 mm, 0=excellent and 100=poor), patient's global assessment of disease activity on arthritis (0-100 mm, 0=excellent and 100=poor), PASI (0-72), and PsA Quality of Life Index (derived as PsAQOL=25.355 + [2.367*HAQ-DI]-[0.234*SF-PCS]-[0.244*SF-MCS]), where HAQ-DI: HAQ-DI score (0-3, 0=least difficulty and 3=extreme difficulty), SF-PCS (Score ranges from 0-100, higher scores= better quality of life) and SF-MCS (score ranges from 0-100, higher scores= better quality of life). Total score is from 0-10, lower score=better response. Higher score indicates more active disease activity. Negative change from baseline indicates improvement of PsA disease activity.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=228 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=232 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=227 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in GRAPPA Composite Score (GRACE) at Weeks 52, 76 and 100 Week 52	-3.105 units on a scale Standard Deviation 1.6208	-3.266 units on a scale Standard Deviation 1.6443	-3.298 units on a scale Standard Deviation 1.5457
Change From Baseline in GRAPPA Composite Score (GRACE) at Weeks 52, 76 and 100 Week 76	-3.499 units on a scale Standard Deviation 1.6303	-3.528 units on a scale Standard Deviation 1.5778	-3.541 units on a scale Standard Deviation 1.5048
Change From Baseline in GRAPPA Composite Score (GRACE) at Weeks 52, 76 and 100 Week 100	-3.561 units on a scale Standard Deviation 1.6389	-3.656 units on a scale Standard Deviation 1.6071	-3.664 units on a scale Standard Deviation 1.5205

SECONDARY outcome

Timeframe: Weeks 52, 76 and 100

Population: Analysis population is FAS3 which included all participants still on treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

GRACE index is a composite PsA disease activity score converted from Arithmetic Mean of Desirability Function (AMDF), derived from TJC (0-68) and SJC (0-66), HAQ-DI (0-3), PtGA of disease activity on arthritis and psoriasis (0-100 mm, 0=excellent and 100=poor), patient's assessment of skin disease activity (0-100 mm, 0=excellent and 100=poor), PtGA of disease activity on arthritis (0-100 mm, 0=excellent and 100=poor), PASI (0-72), and PsA Quality of Life Index (derived as PsAQOL=25.355 + [2.367*HAQ-DI]-[0.234*SF-PCS]-[0.244*SF-MCS]), where HAQ-DI: HAQ-DI score (0-3, 0=least difficulty and 3=extreme difficulty), SF-PCS (Score range= 0-100, higher scores= better quality of life) and SF-MCS (score range=0-100, higher scores= better quality of life). Total score is 0-10, lower score=better response. Higher score= more active disease activity. Negative change from baseline indicates improvement of PsA disease activity. GRACE low disease activity is GRACE score <=2.3 at the analysis visit.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=228 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=232 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=227 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants With Low Disease Activity Based on Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score Index at Weeks 52, 76 and 100 Week 52	35.4 percentage of participants	42.7 percentage of participants	43.8 percentage of participants
Percentage of Participants With Low Disease Activity Based on Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score Index at Weeks 52, 76 and 100 Week 76	45.7 percentage of participants	48.9 percentage of participants	49.8 percentage of participants
Percentage of Participants With Low Disease Activity Based on Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score Index at Weeks 52, 76 and 100 Week 100	48.1 percentage of participants	51.1 percentage of participants	54.5 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 52, 68, 76, 84 and 100

Population: Analysis population is FAS3 which included all participants still on treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

DAPSA assessed the joint domain of PsA and was derived from the sum of the following components: tender joint count (0-68), swollen joint count (0-66), CRP level (mg/dL, value <lower limit of quantification [LLOQ] is considered equal to half of the value of LLOQ for numerical calculations), patient assessment of pain (0-10cm VAS, 0=no pain, 10=worst possible pain), and patient's global assessment of disease activity on arthritis (0 to 10cm VAS, 0=excellent and 10=poor). A higher score indicates more active disease activity. Negative changes from baseline indicate improvement of PsA disease activity. The assessment does not have a score range with an upper or lower bound.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=228 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=232 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=227 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in DAPSA at Weeks 52, 68, 76, 84 and 100 Week 52	-31.274 units on a scale Standard Deviation 18.8900	-30.604 units on a scale Standard Deviation 17.5366	-32.563 units on a scale Standard Deviation 16.4765
Change From Baseline in DAPSA at Weeks 52, 68, 76, 84 and 100 Week 68	-33.918 units on a scale Standard Deviation 18.0463	-33.146 units on a scale Standard Deviation 18.1727	-34.900 units on a scale Standard Deviation 17.5749
Change From Baseline in DAPSA at Weeks 52, 68, 76, 84 and 100 Week 76	-34.391 units on a scale Standard Deviation 17.4074	-33.062 units on a scale Standard Deviation 17.5186	-34.590 units on a scale Standard Deviation 16.5401
Change From Baseline in DAPSA at Weeks 52, 68, 76, 84 and 100 Week 84	-35.240 units on a scale Standard Deviation 17.7891	-33.622 units on a scale Standard Deviation 18.0612	-34.570 units on a scale Standard Deviation 18.2685
Change From Baseline in DAPSA at Weeks 52, 68, 76, 84 and 100 Week 100	-34.819 units on a scale Standard Deviation 17.9807	-34.019 units on a scale Standard Deviation 19.2678	-35.549 units on a scale Standard Deviation 16.5533

SECONDARY outcome

Timeframe: Weeks 52, 68, 76, 84 and 100

Population: Analysis population is FAS3 which included all participants still on treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed for specified categories at specified timepoints.

DAPSA assessed the joint domain of PsA and was derived from the sum of the following components: tender joint count (0-68), swollen joint count (0-66), CRP level (mg/dL), patient assessment of pain (0-10 cm VAS, 0=no pain, 10=worst possible pain), and patient's global assessment of disease activity on arthritis (0 to 10 cm VAS, 0=excellent and 10=poor). A higher score indicates more active disease activity. The assessment does not have a score range with an upper or lower bound. Low: DAPSA<=14; Remission: DAPSA<=4.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=228 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=232 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=227 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100 Week 100: Remission	18.6 percentage of participants	26.9 percentage of participants	23.7 percentage of participants
Percentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100 Week 52: Low Disease Activity	50.7 percentage of participants	55.2 percentage of participants	55.6 percentage of participants
Percentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100 Week 52: Remission	10.2 percentage of participants	19.4 percentage of participants	17.3 percentage of participants
Percentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100 Week 68: Low Disease Activity	54.1 percentage of participants	64.3 percentage of participants	63.3 percentage of participants
Percentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100 Week 68: Remission	15.6 percentage of participants	23.8 percentage of participants	23.9 percentage of participants
Percentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100 Week 76: Low Disease Activity	58.2 percentage of participants	61.2 percentage of participants	61.4 percentage of participants
Percentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100 Week 76: Remission	16.4 percentage of participants	26.8 percentage of participants	19.7 percentage of participants
Percentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100 Week 84: Low Disease Activity	60.6 percentage of participants	66.5 percentage of participants	64.6 percentage of participants
Percentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100 Week 84: Remission	17.8 percentage of participants	28.0 percentage of participants	23.6 percentage of participants
Percentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100 Week 100: Low Disease Activity	61.9 percentage of participants	65.9 percentage of participants	68.9 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 52, 76 and 100

Population: Analysis population is FAS3 which included all participants still on treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

The mCPDAI assessed 4 domains (joints, skin, entheses, and dactylitis). The mCPDAI scores were calculated using the following assessments: joints (66 swollen and 68 tender joint counts), HAQ-DI score, PASI, dactylitis, and enthesitis. Within each domain a score (range 0-3) was assigned, where 0= Not involved, 1= Mild, 2= Moderate and 3= Severe. The scores for each domain were then added together to give a final score range of 0 to 12. A higher score indicates more active disease activity. Negative changes from baseline indicate improvement of PsA disease activity.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=228 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=232 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=227 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in mCPDAI Score at Weeks 52, 76 and 100 Week 100	-4.44 units on a scale Standard Deviation 2.484	-4.38 units on a scale Standard Deviation 2.433	-4.52 units on a scale Standard Deviation 2.519
Change From Baseline in mCPDAI Score at Weeks 52, 76 and 100 Week 52	-3.78 units on a scale Standard Deviation 2.392	-3.83 units on a scale Standard Deviation 2.458	-4.14 units on a scale Standard Deviation 2.358
Change From Baseline in mCPDAI Score at Weeks 52, 76 and 100 Week 76	-4.39 units on a scale Standard Deviation 2.425	-4.16 units on a scale Standard Deviation 2.539	-4.47 units on a scale Standard Deviation 2.347

SECONDARY outcome

Timeframe: Weeks 52, 76 and 100

Population: Analysis population is FAS3 which included all participants still on treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

The mCPDAI assessed 4 domains (joints, skin, entheses, and dactylitis). The mCPDAI scores were calculated using the following assessments: joints (66 swollen and 68 tender joint counts), HAQ-DI score, PASI, dactylitis, and enthesitis. Within each domain a score (range 0-3) was assigned, where 0= Not involved, 1= Mild, 2= Moderate and 3= Severe. The scores for each domain were then added together to give a final score range of 0 to 12. A higher score indicates more active disease activity. Negative changes from baseline indicate improvement of PsA disease activity. mCPDAI low disease activity is defined as mCPDAI score <=3.2 at the analysis visit.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=228 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=232 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=227 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants With Low Disease Activity Based on mCPDAI at Weeks 52, 76 and 100 Week 52	56.6 percentage of participants	61.2 percentage of participants	60.6 percentage of participants
Percentage of Participants With Low Disease Activity Based on mCPDAI at Weeks 52, 76 and 100 Week 76	64.3 percentage of participants	63.7 percentage of participants	68.6 percentage of participants
Percentage of Participants With Low Disease Activity Based on mCPDAI at Weeks 52, 76 and 100 Week 100	67.5 percentage of participants	71.7 percentage of participants	68.0 percentage of participants

SECONDARY outcome

Timeframe: Weeks 52, 76 and 100

Population: Analysis population is FAS3 which included all participants still on treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

MDA is a measure that defines a satisfactory state of disease activity that includes the 5 domains of PsA (joint symptoms, skin psoriasis, patient's perspective of pain and disease activity, physical function, and enthesitis). A participant was considered as having achieved the PsA MDA at a visit if the participant has fulfilled at least 5 of the following 7 criteria at that visit: Tender joint count (68 joints)<=1, Swollen joint count (66 joints) <=1, Psoriasis activity and severity index <=1, Patient's Assessment of Pain <=15 on a 100-unit VAS, Patient's Global Assessment of Disease Activity (arthritis and psoriasis) <=20 on a 100-unit VAS, HAQ-DI score <=0.5, and Tender entheseal points <= 1 (LEI index score <= 1).

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=228 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=232 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=227 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 52, 76 and 100 Week 52	32.0 percentage of participants	32.8 percentage of participants	37.2 percentage of participants
Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 52, 76 and 100 Week 76	34.7 percentage of participants	40.0 percentage of participants	39.0 percentage of participants
Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 52, 76 and 100 Week 100	42.5 percentage of participants	44.6 percentage of participants	42.7 percentage of participants

SECONDARY outcome

Timeframe: Weeks 52, 76 and 100

Population: Analysis population is FAS3 which included all participants still on treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

A measurement that defines a satisfactory state of disease activity that includes the 5 domains of PsA (joint symptoms, skin psoriasis, patient's perspective of pain and disease activity, physical function, and enthesitis). A participant was considered as having achieved VLDA at a visit if the participant fulfilled all 7 criteria (tender joint count <=1; swollen joint count <=1; PASI <=1; patient pain VAS score of <=15; patient global disease activity VAS [arthritis and psoriasis] score of <=20; Health Assessment Questionnaire (HAQ) score <=0.5; and tender entheseal points <=1) at that visit.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=228 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=232 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=227 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants With VLDA at Weeks 52, 76 and 100 Week 52	7.0 percentage of participants	16.8 percentage of participants	12.4 percentage of participants
Percentage of Participants With VLDA at Weeks 52, 76 and 100 Week 76	12.2 percentage of participants	19.6 percentage of participants	14.8 percentage of participants
Percentage of Participants With VLDA at Weeks 52, 76 and 100 Week 100	14.6 percentage of participants	18.8 percentage of participants	15.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 52, 76 and 100

Population: Analysis population is FAS3 among participants with spondylitis and peripheral arthritis and BASDAI Score\>0 at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a self-assessment tool that consists of 6 questions relating to the 5 major symptoms of ankylosing spondylitis: fatigue, spinal pain, joint pain, enthesitis, qualitative morning stiffness and quantitative morning stiffness. The first 5 items were scored on a 10 centimeter (cm) VAS ranging from 0=none to 10=very severe. Quantitative morning stiffness was scored on a 10cm VAS ranging from 0=0 hours to 10=2 or more hours. The 2 scores for qualitative and quantitative morning stiffness were averaged, and the total BASDAI score was the average of the 5 scores of each symptom, ranging from 0 (none) to 10 (very severe). Higher scores indicate greater disease severity and an improvement of 50% from baseline is considered clinically meaningful. Only participants with spondylitis and peripheral arthritis as their primary arthritic presentation of PsA completed the BASDAI indicate the degree of their symptoms over the past week.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=88 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=63 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=79 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among Participants With Spondylitis and Peripheral Arthritis and BASDAI Score>0 at Baseline Week 52	-2.986 units on a scale Standard Deviation 2.4945	-2.923 units on a scale Standard Deviation 2.5194	-3.084 units on a scale Standard Deviation 2.1843
Change From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among Participants With Spondylitis and Peripheral Arthritis and BASDAI Score>0 at Baseline Week 76	-3.311 units on a scale Standard Deviation 2.6106	-3.377 units on a scale Standard Deviation 2.5969	-3.129 units on a scale Standard Deviation 2.1122
Change From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among Participants With Spondylitis and Peripheral Arthritis and BASDAI Score>0 at Baseline Week 100	-3.718 units on a scale Standard Deviation 2.3960	-3.472 units on a scale Standard Deviation 2.5233	-3.330 units on a scale Standard Deviation 2.1598

SECONDARY outcome

Timeframe: Weeks 52, 76 and 100

Population: Analysis population is FAS3 among participants with spondylitis and peripheral arthritis and BASDAI score \>0 at Baseline. Here, n (number analyzed) signifies the number of participants analyzed for specified categories at specified timepoints.

Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a self-assessment tool that consists of 6 questions relating to the 5 major symptoms of ankylosing spondylitis: fatigue, spinal pain, joint pain, enthesitis, qualitative morning stiffness and quantitative morning stiffness. The first 5 items were scored on a 10 centimeter (cm) VAS ranging from 0=none to 10=very severe. Quantitative morning stiffness was scored on a 10cm VAS ranging from 0=0 hours to 10=2 or more hours. The 2 scores for qualitative and quantitative morning stiffness were averaged, and the total BASDAI score was the average of the 5 scores of each symptom, ranging from 0 (none) to 10 (very severe). Higher scores indicate greater disease severity and an improvement of 50% from baseline is considered clinically meaningful. Only participants with spondylitis and peripheral arthritis as their primary arthritic presentation of PsA completed the BASDAI indicate the degree of their symptoms over the past week.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=88 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=63 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=79 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline Week 52: Participants with >=20% Improvement	71.6 percentage of participants	69.8 percentage of participants	79.7 percentage of participants
Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline Week 76: Participants with >=20% Improvement	74.1 percentage of participants	82.0 percentage of participants	81.8 percentage of participants
Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline Week 100: Participants with >=20% Improvement	87.8 percentage of participants	77.0 percentage of participants	82.9 percentage of participants
Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline Week 52: Participants with >=50% Improvement	50.0 percentage of participants	42.9 percentage of participants	50.6 percentage of participants
Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline Week 76: Participants with >=50% Improvement	52.9 percentage of participants	52.5 percentage of participants	50.6 percentage of participants
Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline Week 100: Participants with >=50% Improvement	59.8 percentage of participants	57.4 percentage of participants	55.3 percentage of participants
Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline Week 52: Participants with >=70% Improvement	23.9 percentage of participants	27.0 percentage of participants	30.4 percentage of participants
Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline Week 76: Participants with >=70% Improvement	31.8 percentage of participants	31.1 percentage of participants	26.0 percentage of participants
Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline Week 100: Participants with >=70% Improvement	32.9 percentage of participants	39.3 percentage of participants	32.9 percentage of participants
Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline Week 52: Participants with >=90% Improvement	6.8 percentage of participants	11.1 percentage of participants	8.9 percentage of participants
Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline Week 76: Participants with >=90% Improvement	11.8 percentage of participants	13.1 percentage of participants	7.8 percentage of participants
Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline Week 100: Participants with >=90% Improvement	18.3 percentage of participants	11.5 percentage of participants	9.2 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 52, 76 and 100

Population: Analysis population is FAS3 among participants with \>=3% BSA Psoriatic Involvement and an IGA Score of \>=2 (mild) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. Negative change from baseline indicates improvement of psoriasis.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=172 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=169 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=174 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in PASI Score at Weeks 52, 76 and 100 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 52	-11.030 units on a scale Standard Deviation 10.0077	-11.991 units on a scale Standard Deviation 12.1194	-12.875 units on a scale Standard Deviation 11.2905
Change From Baseline in PASI Score at Weeks 52, 76 and 100 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 76	-11.313 units on a scale Standard Deviation 10.0631	-11.991 units on a scale Standard Deviation 12.2656	-13.242 units on a scale Standard Deviation 11.8845
Change From Baseline in PASI Score at Weeks 52, 76 and 100 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 100	-11.089 units on a scale Standard Deviation 10.0239	-12.101 units on a scale Standard Deviation 12.1322	-13.274 units on a scale Standard Deviation 11.9673

SECONDARY outcome

Timeframe: Weeks 52, 76 and 100

Population: Analysis population is FAS3 among participants with \>=3% BSA Psoriatic Involvement and an IGA Score of \>=2 (mild) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severity. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. PASI 50 response: >=50% improvement in PASI score from baseline.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=172 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=169 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=174 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved PASI 50 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 52	95.9 percentage of participants	97.0 percentage of participants	98.3 percentage of participants
Percentage of Participants Who Achieved PASI 50 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 76	97.6 percentage of participants	96.4 percentage of participants	97.1 percentage of participants
Percentage of Participants Who Achieved PASI 50 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 100	95.6 percentage of participants	97.0 percentage of participants	98.2 percentage of participants

SECONDARY outcome

Timeframe: Weeks 52, 76 and 100

Population: Analysis population is FAS3 among participants with \>=3% BSA Psoriatic Involvement and an IGA Score of \>=2 (mild) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severity. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. PASI 75 response: >=75% improvement in PASI score from baseline.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=172 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=169 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=174 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved PASI 75 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 52	88.3 percentage of participants	88.8 percentage of participants	91.9 percentage of participants
Percentage of Participants Who Achieved PASI 75 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 76	92.8 percentage of participants	87.9 percentage of participants	93.0 percentage of participants
Percentage of Participants Who Achieved PASI 75 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 100	91.9 percentage of participants	87.8 percentage of participants	89.4 percentage of participants

SECONDARY outcome

Timeframe: Weeks 52, 76 and 100

Population: Analysis population is FAS3 among participants with \>=3% BSA Psoriatic Involvement and an IGA Score of \>=2 (mild) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severity. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. PASI 90 response: >=90% improvement in PASI score from baseline.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=172 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=169 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=174 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved PASI 90 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 52	76.6 percentage of participants	76.9 percentage of participants	81.5 percentage of participants
Percentage of Participants Who Achieved PASI 90 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 76	85.5 percentage of participants	75.8 percentage of participants	80.2 percentage of participants
Percentage of Participants Who Achieved PASI 90 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 100	87.5 percentage of participants	75.0 percentage of participants	80.0 percentage of participants

SECONDARY outcome

Timeframe: Weeks 52, 76 and 100

Population: Analysis population is FAS3 among participants with \>=3% BSA Psoriatic Involvement and an IGA Score of \>=2 (mild) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severity. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. PASI 100 response: 100% improvement in PASI score from baseline.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=172 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=169 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=174 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved PASI 100 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 52	55.0 percentage of participants	54.4 percentage of participants	60.7 percentage of participants
Percentage of Participants Who Achieved PASI 100 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 76	65.1 percentage of participants	59.4 percentage of participants	68.0 percentage of participants
Percentage of Participants Who Achieved PASI 100 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 100	69.4 percentage of participants	57.3 percentage of participants	64.1 percentage of participants

SECONDARY outcome

Timeframe: Weeks 52, 76 and 100

Population: Analysis population is FAS3 among participants with \>=3% BSA Psoriatic Involvement and an IGA Score of \>=2 (mild) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

In PASI, each area (head, trunk, upper and lower extremities) was assessed for % of area involved and translated to numeric score from 0 (no involvement) to 6 (90-100% involvement) and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI produces numeric score from 0 to 72. Higher scores=more severe disease. PASI 75: >=75% improvement in PASI score from baseline. ACR 20: >=20% improvement in swollen joint count (SJC) (66 joints) + tender joint count (TJC) (68 joints) and >=20% improvement in 3 of 5: patient's assessment of pain (VAS; 0-100 mm, 0=no pain to 100=worst possible pain), PtGA of disease activity (VAS; 0-100 mm, 0=excellent to 100=poor), PGA of disease activity (VAS; 0-100 mm, 0=no arthritis to 100=extremely active arthritis), patient's assessment of physical function (HAQ-DI -20-question instrument; range- 0=no difficulty to 3=inability to perform task) and CRP.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=172 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=169 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=174 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved Both PASI 75 and ACR 20 Responses at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 52	59.4 percentage of participants	73.4 percentage of participants	70.5 percentage of participants
Percentage of Participants Who Achieved Both PASI 75 and ACR 20 Responses at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 76	71.1 percentage of participants	75.8 percentage of participants	76.7 percentage of participants
Percentage of Participants Who Achieved Both PASI 75 and ACR 20 Responses at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 100	73.0 percentage of participants	76.1 percentage of participants	77.5 percentage of participants

SECONDARY outcome

Timeframe: Weeks 52, 76 and 100

Population: Analysis population is FAS3 among participants with \>=3% BSA Psoriatic Involvement and an IGA Score of \>=2 (mild) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

In PASI, each area (head, trunk, upper and lower extremities) was assessed separately for % of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90-100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI produces numeric score range from 0 to 72. Higher scores=more severe disease. PASI 75 response: >=75% improvement in PASI score from baseline. Modified PsARC response: improvement in at least 2 of 4 criteria: >=30% decrease in SJC and TJC, >=20% improvement in PtGA of Disease Activity (arthritis) on VAS (0-100 mm, 0=excellent and 100=poor), >=20% improvement in PGA of Disease Activity on VAS (VAS: 0-100 mm, 0=no arthritis and 100=extremely active arthritis), and at least 1 of 2 joint criteria with no deterioration in other criteria.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=172 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=169 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=174 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved Both PASI 75 and Modified PsARC Response at Weeks 52, 76, and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 52	70.8 percentage of participants	79.3 percentage of participants	76.9 percentage of participants
Percentage of Participants Who Achieved Both PASI 75 and Modified PsARC Response at Weeks 52, 76, and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 76	78.3 percentage of participants	79.4 percentage of participants	82.6 percentage of participants
Percentage of Participants Who Achieved Both PASI 75 and Modified PsARC Response at Weeks 52, 76, and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 100	78.8 percentage of participants	81.1 percentage of participants	78.8 percentage of participants

SECONDARY outcome

Timeframe: Weeks 52, 76 and 100

Population: Analysis population is FAS3 among participants with \>=3% BSA Psoriatic Involvement and an IGA Score of \>=2 (mild) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

A psoriasis IGA response was defined as an IGA score of 0 (cleared) or 1 (minimal) and >= 2 grade reduction from baseline in the IGA psoriasis score. The IGA documents the investigator's assessment of the patient's psoriasis and lesions are graded for induration, erythema and scaling, each using a 5 point scale: 0 (no evidence), 1 (minimal), 2 (mild), 3 (moderate), and 4 (severe). The IGA score of psoriasis was based upon the average of induration, erythema and scaling scores. The participant's psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). IGA Response is defined as achieving IGA score of 0 or 1, and >=2 grade reduction from baseline.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=172 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=169 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=174 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants With an IGA Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 52	84.2 percentage of participants	76.9 percentage of participants	84.4 percentage of participants
Percentage of Participants With an IGA Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 76	85.5 percentage of participants	77.6 percentage of participants	86.0 percentage of participants
Percentage of Participants With an IGA Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 100	88.1 percentage of participants	76.4 percentage of participants	82.4 percentage of participants

SECONDARY outcome

Timeframe: Weeks 52, 76 and 100

Population: Analysis population is FAS3 among participants with \>=3% BSA Psoriatic Involvement and an IGA Score of \>=2 (mild) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

A psoriasis IGA response was defined as an IGA score of 0 (cleared) or 1 (minimal) and >= 2 grade reduction from baseline in the IGA psoriasis score. The IGA documents the investigator's assessment of the patient's psoriasis and lesions are graded for induration, erythema and scaling, each using a 5 point scale: 0 (no evidence), 1 (minimal), 2 (mild), 3 (moderate), and 4 (severe). The IGA score of psoriasis was based upon the average of induration, erythema and scaling scores. The participant's psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=172 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=169 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=174 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants With an IGA Score of 0 (Cleared) at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 52	66.7 percentage of participants	59.8 percentage of participants	65.9 percentage of participants
Percentage of Participants With an IGA Score of 0 (Cleared) at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 76	72.9 percentage of participants	64.2 percentage of participants	72.1 percentage of participants
Percentage of Participants With an IGA Score of 0 (Cleared) at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 100	76.9 percentage of participants	58.8 percentage of participants	67.1 percentage of participants

SECONDARY outcome

Timeframe: Weeks 52, 76 and 100

Population: Analysis population is FAS3 among the participants with DLQI Score \>1, with \>=3% BSA psoriatic involvement and an IGA score of \>=2 (mild) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Dermatology Life Quality Index (DLQI) is a 10-item instrument questionnaire used to assess the patient's perspective of the impact of psoriasis on daily living. Each item was scored on a 4-point scale (0 =not at all /not relevant; 1 =a little; 2 =a lot; 3 =very much), and the total score (0-30) is the sum of the 10 items. The higher the score, the more quality of life is impaired. A DLQI score of 0 or 1 indicates psoriasis had no effect at all on patient's life.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=161 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=152 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=163 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved a DLQI Score of 0 or 1 at Weeks 52, 76 and 100 Among the Participants With DLQI Score >1, With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 52	56.5 percentage of participants	68.4 percentage of participants	68.5 percentage of participants
Percentage of Participants Who Achieved a DLQI Score of 0 or 1 at Weeks 52, 76 and 100 Among the Participants With DLQI Score >1, With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 76	66.9 percentage of participants	66.7 percentage of participants	68.9 percentage of participants
Percentage of Participants Who Achieved a DLQI Score of 0 or 1 at Weeks 52, 76 and 100 Among the Participants With DLQI Score >1, With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 100	74.7 percentage of participants	69.6 percentage of participants	64.8 percentage of participants

SECONDARY outcome

Timeframe: Weeks 52, 76 and 100

Population: Analysis population is FAS3 among the participants with DLQI score \>=5, \>=3% BSA psoriatic involvement and an IGA score of \>=2 (mild) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Dermatology Life Quality Index (DLQI) is a 10-item instrument questionnaire used to assess the patient's perspective of the impact of psoriasis on daily living. Each item was scored on a 4-point scale (0 =not at all /not relevant; 1 =a little; 2 =a lot; 3 =very much), and the total score (0-30) is the sum of the 10 items. The higher the score, the more quality of life is impaired. An improvement of 5 points was considered clinically meaningful.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=138 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=129 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=143 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved >=5-point Improvement From Baseline in DLQI Score at Weeks 52, 76 and 100 Among the Participants With DLQI Score >=5, >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 52	84.8 percentage of participants	92.2 percentage of participants	89.4 percentage of participants
Percentage of Participants Who Achieved >=5-point Improvement From Baseline in DLQI Score at Weeks 52, 76 and 100 Among the Participants With DLQI Score >=5, >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 76	91.9 percentage of participants	89.0 percentage of participants	90.1 percentage of participants
Percentage of Participants Who Achieved >=5-point Improvement From Baseline in DLQI Score at Weeks 52, 76 and 100 Among the Participants With DLQI Score >=5, >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 100	91.7 percentage of participants	94.4 percentage of participants	88.5 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 52, 76 and 100

Population: Analysis population is FAS3 among the participants with \>=3% BSA psoriatic involvement and an IGA Score of \>=2 (mild) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Dermatology Life Quality Index (DLQI) is a 10-item instrument questionnaire used to assess the patient's perspective of the impact of psoriasis on daily living. Each item was scored on a 4-point scale (0 =not at all /not relevant; 1 =a little; 2 =a lot; 3 =very much), and the total score (0-30) is the sum of the 10 items. The higher the score, the more quality of life is impaired. Negative changes from baseline indicate improvement of life quality impacted by psoriasis.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=172 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=169 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=174 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in DLQI Score at Weeks 52, 76 and 100 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 52	-8.855 units on a scale Standard Deviation 7.2738	-9.272 units on a scale Standard Deviation 7.3903	-9.873 units on a scale Standard Deviation 6.8832
Change From Baseline in DLQI Score at Weeks 52, 76 and 100 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 76	-10.090 units on a scale Standard Deviation 7.0888	-9.180 units on a scale Standard Deviation 7.2977	-9.610 units on a scale Standard Deviation 7.0383
Change From Baseline in DLQI Score at Weeks 52, 76 and 100 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 100	-10.130 units on a scale Standard Deviation 7.2798	-9.291 units on a scale Standard Deviation 7.2851	-9.635 units on a scale Standard Deviation 7.0884

SECONDARY outcome

Timeframe: Baseline to Week 100

Population: FAS3 for structural damage (FAS3-SD) included all randomized participants who were continuing study treatment at Week 52. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=204 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=216 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=211 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change in Modified vdH-S Score From Baseline to Week 100	1.49 units on a scale Standard Deviation 6.859	1.50 units on a scale Standard Deviation 4.393	1.68 units on a scale Standard Deviation 7.018

SECONDARY outcome

Timeframe: From Week 52 to Week 100

Population: FAS3 for structural damage (FAS3-SD) included all randomized participants who were continuing study treatment at Week 52. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=202 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=216 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=211 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change in Total Modified vdH-S Score From Week 52 to Week 100	0.13 units on a scale Standard Deviation 3.742	0.46 units on a scale Standard Deviation 2.419	0.75 units on a scale Standard Deviation 4.021

SECONDARY outcome

Timeframe: Baseline to Week 100

Population: FAS3 for structural damage (FAS3-SD) included all randomized participants who were continuing study treatment at Week 52. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=204 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=216 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=211 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change in Modified vdH-s Erosion Score From Baseline to Week 100	1.01 units on a scale Standard Deviation 4.034	1.01 units on a scale Standard Deviation 3.355	1.02 units on a scale Standard Deviation 4.676

SECONDARY outcome

Timeframe: From Week 52 to Week 100

Population: FAS3 for structural damage (FAS3-SD) included all randomized participants who were continuing study treatment at Week 52. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=202 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=216 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=211 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change in Modified vdH-s Erosion Score From Week 52 to Week 100	0.09 units on a scale Standard Deviation 1.978	0.26 units on a scale Standard Deviation 1.751	0.45 units on a scale Standard Deviation 2.900

SECONDARY outcome

Timeframe: Baseline to Week 100

Population: FAS3 for structural damage (FAS3-SD) included all randomized participants who were continuing study treatment at Week 52. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=204 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=216 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=211 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change in Modified vdH-s JSN Score From Baseline to Week 100	0.49 units on a scale Standard Deviation 2.984	0.50 units on a scale Standard Deviation 1.387	0.66 units on a scale Standard Deviation 2.722

SECONDARY outcome

Timeframe: From Week 52 to Week 100

Population: FAS3 for structural damage (FAS3-SD) included all randomized participants who were continuing study treatment at Week 52. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=202 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=216 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=211 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change in Modified vdH-s JSN Score From Week 52 to Week 100	0.04 units on a scale Standard Deviation 1.904	0.20 units on a scale Standard Deviation 0.917	0.30 units on a scale Standard Deviation 1.319

SECONDARY outcome

Timeframe: Baseline to Week 100

Population: FAS3 for structural damage (FAS3-SD) included all randomized participants who were continuing study treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed at specified category.

Modified vdH-S score is the sum of the erosion score (hand, feet) and JSN score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand (Hand erosion score) scored according to 0 (no erosion) to 5 (complete collapse of bone) for a maximum hand erosion score of 200, and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum foot erosion score of 120. Higher scores indicate more joint damage. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum Hand JSN score of 160 and maximum Foot JSN score of 48. Higher scores indicate more joint damage. Hand Score (sum of Hand Erosion Score and Hand JSN Score) scored as 0-360 and Foot score (sum of foot erosion score and foot JSN score) scored as 0-168. Higher scores indicate more joint damage.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=228 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=232 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=227 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline to Week 100 in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) Hand Erosion Score	0.67 units on a scale Standard Deviation 2.917	0.67 units on a scale Standard Deviation 2.807	0.49 units on a scale Standard Deviation 3.007
Change From Baseline to Week 100 in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) Hand JSN Score	0.35 units on a scale Standard Deviation 2.443	0.34 units on a scale Standard Deviation 1.247	0.32 units on a scale Standard Deviation 1.845
Change From Baseline to Week 100 in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) Hand Score	1.02 units on a scale Standard Deviation 5.244	1.02 units on a scale Standard Deviation 3.815	0.81 units on a scale Standard Deviation 4.532
Change From Baseline to Week 100 in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) Foot Erosion Score	0.34 units on a scale Standard Deviation 1.596	0.33 units on a scale Standard Deviation 1.362	0.53 units on a scale Standard Deviation 2.436
Change From Baseline to Week 100 in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) Foot JSN Score	0.13 units on a scale Standard Deviation 0.912	0.15 units on a scale Standard Deviation 0.652	0.34 units on a scale Standard Deviation 1.608
Change From Baseline to Week 100 in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) Foot Score	0.48 units on a scale Standard Deviation 2.373	0.48 units on a scale Standard Deviation 1.652	0.87 units on a scale Standard Deviation 3.761

SECONDARY outcome

Timeframe: Baseline to Week 100

Population: FAS3 for structural damage (FAS3-SD) included all randomized participants who were continuing study treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed at specified category.

Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=228 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=232 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=227 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants With a Change of <=0 or <=0.5 From Baseline to Week 100 in Modified vdH-S Score Change of <=0 from Baseline	60.8 percentage of participants	55.6 percentage of participants	62.6 percentage of participants
Percentage of Participants With a Change of <=0 or <=0.5 From Baseline to Week 100 in Modified vdH-S Score Change of <=0.5 from Baseline	72.1 percentage of participants	63.9 percentage of participants	72.5 percentage of participants

SECONDARY outcome

Timeframe: Baseline to Week 100

Population: FAS3 for structural damage (FAS3-SD) included all randomized participants who were continuing study treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed at specified category.

Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=228 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=232 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=227 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants With a Change of <=0 or <=0.5 From Baseline to Week 100 in Modified vdH-S Erosion Score Change of <=0 from Baseline	64.2 percentage of participants	61.1 percentage of participants	65.4 percentage of participants
Percentage of Participants With a Change of <=0 or <=0.5 From Baseline to Week 100 in Modified vdH-S Erosion Score Change of <=0.5 from Baseline	75.0 percentage of participants	73.1 percentage of participants	75.4 percentage of participants

SECONDARY outcome

Timeframe: Baseline to Week 100

Population: FAS3 for structural damage (FAS3-SD) included all randomized participants who were continuing study treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed at specified category.

Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=228 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=232 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=227 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants With a Change of <=0 or <=0.5 From Baseline to Week 100 in Modified vdH-S JSN Score Change of <=0 from Baseline	77.5 percentage of participants	68.5 percentage of participants	73.9 percentage of participants
Percentage of Participants With a Change of <=0 or <=0.5 From Baseline to Week 100 in Modified vdH-S JSN Score Change of <=0.5 from Baseline	84.3 percentage of participants	79.6 percentage of participants	81.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline to Week 100

Population: FAS3 for structural damage (FAS3-SD) included all randomized participants who were continuing study treatment at Week 52. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Modified vdH-S score is the sum of the erosion score (hand, feet) and JSN score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. SDC was defined as the cut-off above which the changes can be detected beyond measurement error. Without radiographic progression was defined as change from baseline in the modified vdH-S score <=SDC of 3.46.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=204 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=216 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=211 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Without Radiographic Modified vdH-S Progression Based on (SDC) From Baseline to Week 100	86.8 percentage of participants	84.7 percentage of participants	87.2 percentage of participants

SECONDARY outcome

Timeframe: Baseline to Week 100

Population: FAS3 for structural damage (FAS3-SD) included all randomized participants who were continuing study treatment at Week 52. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Modified vdH-S score is sum of the erosion score (hand, feet) and JSN score (hand, feet). Joint erosion score is summary of erosion severity in 40 joints of hand scored according to surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. SDC was defined as the cut-off above which the changes can be detected beyond measurement error. Without radiographic erosion progression was defined as change from baseline in the modified vdH-S erosion score <=SDC of 2.66.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=204 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=216 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=211 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Without Radiographic Erosion Progression (Based on SDC) From Baseline to Week 100	86.8 percentage of participants	87.0 percentage of participants	88.6 percentage of participants

SECONDARY outcome

Timeframe: Baseline to Week 100

Population: FAS3 for structural damage (FAS3-SD) included all randomized participants who were continuing study treatment at Week 52. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Modified vdH-S score is sum of erosion score (hand, feet) and JSN score (hand, feet). Joint erosion score is summary of erosion severity in 40 joints of hand scored according to surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. SDC was defined as the cut-off above which the changes can be detected beyond measurement error. Without radiographic JSN progression was defined as change from baseline in the modified vdH-S JSN score <=SDC of 1.66.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=204 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=216 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=211 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Without Radiographic JSN Progression (Based on SDC) From Baseline to Week 100	90.7 percentage of participants	89.4 percentage of participants	88.2 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 24, 52, and 100

Population: FAS3 for structural damage (FAS3-SD) included all randomized participants who were continuing study treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Pencil in Cup or Gross Osteolytis Deformities are radiographic features specific for psoriatic arthritis.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=228 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=232 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=227 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline, Weeks 24, 52, and 100 Baseline	3.7 percentage of participants	3.9 percentage of participants	3.6 percentage of participants
Percentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline, Weeks 24, 52, and 100 Week 24	3.7 percentage of participants	3.9 percentage of participants	4.1 percentage of participants
Percentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline, Weeks 24, 52, and 100 Week 52	4.2 percentage of participants	4.4 percentage of participants	3.6 percentage of participants
Percentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline, Weeks 24, 52, and 100 Week 100	4.9 percentage of participants	4.6 percentage of participants	3.8 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 52, 76 and 100

Population: Analysis population is FAS3. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The PCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=228 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=232 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=227 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in SF-36 PCS Score at Weeks 52, 76 and 100 Week 52	8.170 units on a scale Standard Deviation 8.2195	9.438 units on a scale Standard Deviation 8.2854	9.023 units on a scale Standard Deviation 8.6263
Change From Baseline in SF-36 PCS Score at Weeks 52, 76 and 100 Week 76	9.762 units on a scale Standard Deviation 8.5908	10.814 units on a scale Standard Deviation 9.0290	9.707 units on a scale Standard Deviation 8.5010
Change From Baseline in SF-36 PCS Score at Weeks 52, 76 and 100 Week 100	10.508 units on a scale Standard Deviation 8.6819	11.282 units on a scale Standard Deviation 9.2753	10.559 units on a scale Standard Deviation 8.7449

SECONDARY outcome

Timeframe: Baseline, Weeks 52, 76 and 100

Population: Analysis population is FAS3. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The MCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=228 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=232 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=227 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in SF-36 MCS Score at Weeks 52, 76 and 100 Week 52	4.383 units on a scale Standard Deviation 10.9402	4.540 units on a scale Standard Deviation 9.7848	4.127 units on a scale Standard Deviation 9.1368
Change From Baseline in SF-36 MCS Score at Weeks 52, 76 and 100 Week 76	4.838 units on a scale Standard Deviation 11.0526	5.034 units on a scale Standard Deviation 10.0334	5.194 units on a scale Standard Deviation 9.4899
Change From Baseline in SF-36 MCS Score at Weeks 52, 76 and 100 Week 100	4.610 units on a scale Standard Deviation 11.2527	4.718 units on a scale Standard Deviation 9.9014	4.936 units on a scale Standard Deviation 9.5935

SECONDARY outcome

Timeframe: Baseline, Weeks 52, 76 and 100

Population: Analysis population is FAS3. Here, n (number analyzed) signifies the number of participants analyzed for specified categories at specified timepoints.

SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales: physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health. The scores 0-100 (where higher scores indicated a better quality of life) from each subscale of SF-36 were normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. Higher score indicates better health status. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=228 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=232 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=227 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 Week 100: Social Function Score	7.825 units on a scale Standard Deviation 10.8558	8.080 units on a scale Standard Deviation 9.5383	8.113 units on a scale Standard Deviation 9.4847
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 Week 52: Physical Function Score	7.757 units on a scale Standard Deviation 8.9727	8.406 units on a scale Standard Deviation 8.8407	8.493 units on a scale Standard Deviation 8.7691
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 Week 76: Physical Function Score	8.824 units on a scale Standard Deviation 9.6648	9.807 units on a scale Standard Deviation 9.5044	9.294 units on a scale Standard Deviation 8.2020
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 Week 100: Physical Function Score	9.738 units on a scale Standard Deviation 9.8405	10.953 units on a scale Standard Deviation 9.7761	10.126 units on a scale Standard Deviation 8.9271
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 Week 52: Role-physical Score	6.538 units on a scale Standard Deviation 8.5151	7.665 units on a scale Standard Deviation 8.2925	7.372 units on a scale Standard Deviation 7.7581
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 Week 76: Role-physical Score	8.372 units on a scale Standard Deviation 8.7202	9.171 units on a scale Standard Deviation 8.5844	8.579 units on a scale Standard Deviation 7.6709
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 Week 100: Role-physical Score	9.181 units on a scale Standard Deviation 8.6596	9.342 units on a scale Standard Deviation 9.1746	8.921 units on a scale Standard Deviation 8.1775
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 Week 52: Bodily Pain Score	8.536 units on a scale Standard Deviation 8.4602	10.201 units on a scale Standard Deviation 8.7312	9.525 units on a scale Standard Deviation 9.8357
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 Week 76: Bodily Pain Score	10.368 units on a scale Standard Deviation 9.1058	11.552 units on a scale Standard Deviation 9.8591	10.300 units on a scale Standard Deviation 9.0504
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 Week 100: Bodily Pain Score	10.696 units on a scale Standard Deviation 9.3854	11.585 units on a scale Standard Deviation 10.3527	10.998 units on a scale Standard Deviation 8.9230
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 Week 52: General Health Score	6.533 units on a scale Standard Deviation 8.5245	7.097 units on a scale Standard Deviation 7.2500	6.450 units on a scale Standard Deviation 8.4316
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 Week 76: General Health Score	7.203 units on a scale Standard Deviation 8.3372	7.470 units on a scale Standard Deviation 7.6119	6.761 units on a scale Standard Deviation 7.9631
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 Week 100: General Health Score	6.710 units on a scale Standard Deviation 8.7265	7.066 units on a scale Standard Deviation 7.5829	7.132 units on a scale Standard Deviation 8.4887
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 Week 52: Vitality Score	7.997 units on a scale Standard Deviation 9.3878	8.695 units on a scale Standard Deviation 9.5033	7.637 units on a scale Standard Deviation 9.4393
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 Week 76: Vitality Score	8.859 units on a scale Standard Deviation 9.4372	9.388 units on a scale Standard Deviation 9.8618	8.659 units on a scale Standard Deviation 9.6026
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 Week 100: Vitality Score	9.648 units on a scale Standard Deviation 9.4778	9.827 units on a scale Standard Deviation 9.9348	9.155 units on a scale Standard Deviation 9.3569
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 Week 52: Social Function Score	6.361 units on a scale Standard Deviation 10.9927	7.304 units on a scale Standard Deviation 10.1003	6.810 units on a scale Standard Deviation 9.5118
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 Week 76: Social Function Score	7.509 units on a scale Standard Deviation 10.4249	8.623 units on a scale Standard Deviation 9.5176	7.914 units on a scale Standard Deviation 9.5191
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 Week 52: Role-emotional Score	4.111 units on a scale Standard Deviation 10.9413	4.998 units on a scale Standard Deviation 10.1964	4.699 units on a scale Standard Deviation 8.7759
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 Week 76: Role-emotional Score	5.199 units on a scale Standard Deviation 11.1875	5.757 units on a scale Standard Deviation 10.0737	5.433 units on a scale Standard Deviation 9.2389
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 Week 100: Role-emotional Score	4.784 units on a scale Standard Deviation 11.9482	5.720 units on a scale Standard Deviation 10.1991	5.128 units on a scale Standard Deviation 9.7998
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 Week 52: Mental Health Score	5.209 units on a scale Standard Deviation 10.0958	4.826 units on a scale Standard Deviation 9.4038	4.839 units on a scale Standard Deviation 9.4029
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 Week 76: Mental Health Score	5.481 units on a scale Standard Deviation 10.5927	5.430 units on a scale Standard Deviation 10.0802	6.124 units on a scale Standard Deviation 8.7930
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 Week 100: Mental Health Score	5.514 units on a scale Standard Deviation 10.6204	5.477 units on a scale Standard Deviation 10.1202	6.148 units on a scale Standard Deviation 8.8743

SECONDARY outcome

Timeframe: Weeks 52, 76 and 100

Population: Analysis population is FAS3. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The PCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. Higher score indicates better outcome, with an increase of 5 points considered to be clinically meaningful.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=228 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=232 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=227 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score at Weeks 52, 76 and 100 Week 52	63.4 percentage of participants	66.8 percentage of participants	65.9 percentage of participants
Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score at Weeks 52, 76 and 100 Week 76	70.6 percentage of participants	73.8 percentage of participants	65.5 percentage of participants
Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score at Weeks 52, 76 and 100 Week 100	72.4 percentage of participants	70.1 percentage of participants	68.6 percentage of participants

SECONDARY outcome

Timeframe: Weeks 52, 76 and 100

Population: Analysis population is FAS3. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The MCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. Higher score indicates better outcome, with an increase of 5 points considered to be clinically meaningful.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=228 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=232 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=227 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score at Weeks 52, 76 and 100 Week 76	43.9 percentage of participants	44.4 percentage of participants	43.5 percentage of participants
Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score at Weeks 52, 76 and 100 Week 100	42.1 percentage of participants	46.4 percentage of participants	43.6 percentage of participants
Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score at Weeks 52, 76 and 100 Week 52	42.3 percentage of participants	45.3 percentage of participants	38.9 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 52, 76 and 100

Population: Analysis population is FAS3. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

The FACIT-Fatigue is a questionnaire that assesses self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue. The subscale consists 13-item instrument to measure fatigue. Each of the 13 items has a set of five response categories: Not at all (=0), A little bit (=1), Somewhat (=2), Quite a bit (=3) and Very much (=4). A total FACIT-Fatigue subscale score was calculated as the sum of the 13 item scores (reserved scores [4 - score]) and ranges from 0 to 52, with a higher score indicating less fatigue. Positive changes from baseline indicate improvement of fatigue. Items were reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatigue.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=228 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=232 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=227 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 52, 76 and 100 Week 52	7.692 units on a scale Standard Deviation 9.3071	8.935 units on a scale Standard Deviation 9.5033	7.699 units on a scale Standard Deviation 9.1417
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 52, 76 and 100 Week 76	9.167 units on a scale Standard Deviation 9.0455	9.596 units on a scale Standard Deviation 10.4788	8.632 units on a scale Standard Deviation 8.8429
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 52, 76 and 100 Week 100	9.435 units on a scale Standard Deviation 9.4513	10.107 units on a scale Standard Deviation 10.2076	9.127 units on a scale Standard Deviation 8.9948

SECONDARY outcome

Timeframe: Weeks 52, 76 and 100

Population: Analysis population is FAS3. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

The FACIT-Fatigue is a questionnaire that assesses self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue. The subscale consists 13-item instrument to measure fatigue. Each of the 13 items has a set of five response categories: Not at all (=0), A little bit (=1), Somewhat (=2), Quite a bit (=3) and Very much (=4). A total FACIT-Fatigue subscale score was calculated as the sum of the 13 item scores (reserved scores [4 - score]) and ranges from 0 to 52, with a higher score indicating less fatigue. Items were reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatigue.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=228 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=232 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=227 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score at Weeks 52, 76 and 100 Week 76	70.6 percentage of participants	69.3 percentage of participants	74.4 percentage of participants
Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score at Weeks 52, 76 and 100 Week 52	68.7 percentage of participants	69.4 percentage of participants	68.1 percentage of participants
Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score at Weeks 52, 76 and 100 Week 100	72.0 percentage of participants	72.8 percentage of participants	74.1 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 52, 76 and 100

Population: Analysis population is FAS3. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. The EQ VAS self-rating records the respondent's own assessment of his or her overall health status at the time of completion, on a vertical line VAS with scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine). A higher score indicates better health and positive changes from baseline indicate improvement of health status.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=228 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=232 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=227 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in EQ-5D-5L at Weeks 52, 76 and 100: EQ-VAS Week 52	21.608 units on a scale Standard Deviation 25.5992	23.392 units on a scale Standard Deviation 23.6990	20.190 units on a scale Standard Deviation 24.8348
Change From Baseline in EQ-5D-5L at Weeks 52, 76 and 100: EQ-VAS Week 76	24.176 units on a scale Standard Deviation 27.7205	25.053 units on a scale Standard Deviation 26.0372	22.251 units on a scale Standard Deviation 24.6934
Change From Baseline in EQ-5D-5L at Weeks 52, 76 and 100: EQ-VAS Week 100	25.901 units on a scale Standard Deviation 28.4028	27.152 units on a scale Standard Deviation 26.5221	25.909 units on a scale Standard Deviation 26.0995

SECONDARY outcome

Timeframe: Baseline, Weeks 52, 76 and 100

Population: Analysis population is FAS3. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health "today". Responses were used to generate a weighted summary index (EQ-5D index), which ranges from 0 (dead) to 1.00 (full health). A higher score indicates better health and positive changes from baseline indicate improvement of health.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=228 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=232 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=227 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in EQ-5D-5L at Weeks 52, 76 and 100: EQ-5D Index Week 52	0.138 units on a scale Standard Deviation 0.1608	0.150 units on a scale Standard Deviation 0.1445	0.138 units on a scale Standard Deviation 0.1458
Change From Baseline in EQ-5D-5L at Weeks 52, 76 and 100: EQ-5D Index Week 76	0.154 units on a scale Standard Deviation 0.1744	0.169 units on a scale Standard Deviation 0.1564	0.147 units on a scale Standard Deviation 0.1471
Change From Baseline in EQ-5D-5L at Weeks 52, 76 and 100: EQ-5D Index Week 100	0.164 units on a scale Standard Deviation 0.1605	0.164 units on a scale Standard Deviation 0.1596	0.156 units on a scale Standard Deviation 0.1543

SECONDARY outcome

Timeframe: Baseline, Weeks 52, 76 and 100

Population: Analysis population is FAS3. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, n (number analyzed) signifies the number of participants analyzed for specified categories at specified timepoints.

Work Productivity and Activity Impairment was assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) of PsA (WPAI-PsA). The WPAI-PsA consisted of 6 questions to determine employment status, hours missed from work due to PsA, hours missed from work for other reasons, hours actually worked, the degree to which PsA affected work productivity while at work and the degree to which PsA affected activities outside of work during the past 7 days. WPAI outcomes included percent work time missed due to PsA, percent impairment while working due to PsA, percent overall work impairment due to PsA, and percent activity impairment outside of work due to PsA. These WPAI outcomes were expressed as impairment percentages (0-100, 0=no impairment and 100=100% impaired), with higher numbers indicating greater impairment and less productivity. Negative changes from baseline indicate improvement of work productivity and activity impairment.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=136 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=130 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=130 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in WPAI Scores (Percent Work Time Missed) at Weeks 52, 76 and 100 Week 52	-5.45 units on a scale Standard Deviation 25.544	-4.50 units on a scale Standard Deviation 20.530	-1.83 units on a scale Standard Deviation 17.191
Change From Baseline in WPAI Scores (Percent Work Time Missed) at Weeks 52, 76 and 100 Week 76	-5.92 units on a scale Standard Deviation 26.032	-6.22 units on a scale Standard Deviation 23.133	-2.39 units on a scale Standard Deviation 19.277
Change From Baseline in WPAI Scores (Percent Work Time Missed) at Weeks 52, 76 and 100 Week 100	-8.81 units on a scale Standard Deviation 24.313	-5.81 units on a scale Standard Deviation 21.606	-1.56 units on a scale Standard Deviation 16.956

SECONDARY outcome

Timeframe: Baseline, Weeks 52, 76 and 100

Population: Analysis population is FAS3. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, n (number analyzed) signifies the number of participants analyzed for specified categories at specified timepoints.

Work Productivity and Activity Impairment was assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) of PsA (WPAI-PsA). The WPAI-PsA consisted of 6 questions to determine employment status, hours missed from work due to PsA, hours missed from work for other reasons, hours actually worked, the degree to which PsA affected work productivity while at work and the degree to which PsA affected activities outside of work during the past 7 days. WPAI outcomes included percent work time missed due to PsA, percent impairment while working due to PsA, percent overall work impairment due to PsA, and percent activity impairment outside of work due to PsA. These WPAI outcomes were expressed as impairment percentages (0-100, 0=no impairment and 100=100% impaired), with higher numbers indicating greater impairment and less productivity. Negative changes from baseline indicate improvement of work productivity and activity impairment.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=116 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=121 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=122 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in WPAI Scores (Percent Impairment While Working) at Weeks 52, 76 and 100 Week 52	-21.81 units on a scale Standard Deviation 31.391	-27.93 units on a scale Standard Deviation 25.263	-22.62 units on a scale Standard Deviation 26.058
Change From Baseline in WPAI Scores (Percent Impairment While Working) at Weeks 52, 76 and 100 Week 76	-26.90 units on a scale Standard Deviation 28.965	-29.91 units on a scale Standard Deviation 24.549	-26.13 units on a scale Standard Deviation 25.412
Change From Baseline in WPAI Scores (Percent Impairment While Working) at Weeks 52, 76 and 100 Week 100	-30.73 units on a scale Standard Deviation 30.933	-30.65 units on a scale Standard Deviation 24.771	-27.77 units on a scale Standard Deviation 26.119

SECONDARY outcome

Timeframe: Baseline, Weeks 52, 76 and 100

Population: Analysis population is FAS3. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, n (number analyzed) signifies the number of participants analyzed for specified categories at specified timepoints.

Work Productivity and Activity Impairment was assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) of PsA (WPAI-PsA). The WPAI-PsA consisted of 6 questions to determine employment status, hours missed from work due to PsA, hours missed from work for other reasons, hours actually worked, the degree to which PsA affected work productivity while at work and the degree to which PsA affected activities outside of work during the past 7 days. WPAI outcomes included percent work time missed due to PsA, percent impairment while working due to PsA, percent overall work impairment due to PsA, and percent activity impairment outside of work due to PsA. These WPAI outcomes were expressed as impairment percentages (0-100, 0=no impairment and 100=100% impaired), with higher numbers indicating greater impairment and less productivity. Negative changes from baseline indicate improvement of work productivity and activity impairment.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=116 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=121 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=122 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in WPAI Scores (Percent Overall Work Impairment) at Weeks 52, 76 and 100 Week 52	-22.61 units on a scale Standard Deviation 31.979	-28.19 units on a scale Standard Deviation 25.536	-22.79 units on a scale Standard Deviation 26.793
Change From Baseline in WPAI Scores (Percent Overall Work Impairment) at Weeks 52, 76 and 100 Week 76	-27.98 units on a scale Standard Deviation 29.709	-30.27 units on a scale Standard Deviation 26.058	-26.21 units on a scale Standard Deviation 28.115
Change From Baseline in WPAI Scores (Percent Overall Work Impairment) at Weeks 52, 76 and 100 Week 100	-31.87 units on a scale Standard Deviation 31.013	-31.75 units on a scale Standard Deviation 25.615	-25.21 units on a scale Standard Deviation 26.317

SECONDARY outcome

Timeframe: Baseline, Weeks 52, 76 and 100

Population: Analysis population is FAS3. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Work Productivity and Activity Impairment was assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) of PsA (WPAI-PsA). The WPAI-PsA consisted of 6 questions to determine employment status, hours missed from work due to PsA, hours missed from work for other reasons, hours actually worked, the degree to which PsA affected work productivity while at work and the degree to which PsA affected activities outside of work during the past 7 days. WPAI outcomes included percent work time missed due to PsA, percent impairment while working due to PsA, percent overall work impairment due to PsA, and percent activity impairment outside of work due to PsA. These WPAI outcomes were expressed as impairment percentages (0-100, 0=no impairment and 100=100% impaired), with higher numbers indicating greater impairment and less productivity. Negative changes from baseline indicate improvement of work productivity and activity impairment.

Outcome measures

Measure	Placebo to Guselkumab 100 mg q4w n=228 Participants Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Guselkumab 100 mg q8w n=232 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Guselkumab 100 mg q4w n=227 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Change From Baseline in WPAI Scores (Percent Activity Impairment Outside of Work) Weeks 52, 76 and 100 Week 52	-24.67 units on a scale Standard Deviation 27.106	-27.16 units on a scale Standard Deviation 25.662	-26.24 units on a scale Standard Deviation 25.113
Change From Baseline in WPAI Scores (Percent Activity Impairment Outside of Work) Weeks 52, 76 and 100 Week 76	-28.05 units on a scale Standard Deviation 26.411	-31.38 units on a scale Standard Deviation 25.449	-28.70 units on a scale Standard Deviation 24.635
Change From Baseline in WPAI Scores (Percent Activity Impairment Outside of Work) Weeks 52, 76 and 100 Week 100	-30.70 units on a scale Standard Deviation 28.632	-30.98 units on a scale Standard Deviation 26.650	-30.68 units on a scale Standard Deviation 25.305

Adverse Events

Placebo (CP)

Serious events: 7 serious events

Other events: 30 other events

Deaths: 0 deaths

Guselkumab 100 mg q8w (CP)

Serious events: 3 serious events

Other events: 42 other events

Deaths: 0 deaths

Guselkumab 100 mg q4w (CP)

Serious events: 8 serious events

Other events: 52 other events

Deaths: 0 deaths

Placebo to Guselkumab 100 mg q4w (After CP Through Week 112)

Serious events: 16 serious events

Other events: 48 other events

Deaths: 1 deaths

Guselkumab 100 mg q8w (Through Week 112)

Serious events: 22 serious events

Other events: 88 other events

Deaths: 0 deaths

Guselkumab 100 mg q4w (Through Week 112)

Serious events: 22 serious events

Other events: 79 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo (CP) n=246 participants at risk Participants received placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (CP). Data prior to the first administration of guselkumab, or through the last follow-up visit if the participant did not receive any guselkumab, were included.	Guselkumab 100 mg q8w (CP) n=248 participants at risk Participants received guselkumab 100 milligram (mg) subcutaneous injections at Weeks 0 and 4 then every 8 weeks and placebo matched to guselkumab injections at other visits through Week 20 in the placebo controlled period (CP). Data through Week 24, or through the last follow-up visit if the participant did not receive any study drug at or after Week 24, were included.	Guselkumab 100 mg q4w (CP) n=245 participants at risk Participants received guselkumab 100 milligram (mg) subcutaneous injections every 4 weeks from Week 0 through Week 20 in the placebo controlled period (CP). Data through Week 24, or through the last follow-up visit if the participant did not receive any study drug at or after Week 24, were included.	Placebo to Guselkumab 100 mg q4w (After CP Through Week 112) n=238 participants at risk Participants who received placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (CP) received guselkumab 100 milligram (mg) subcutaneous injections every 4 weeks from Week 24 through Week 100. Data from the first administration of guselkumab through Week 112 (End of Study) were included.	Guselkumab 100 mg q8w (Through Week 112) n=248 participants at risk Participants received guselkumab 100 milligram (mg) subcutaneous injections at Weeks 0 and 4 then every 8 weeks and placebo matched to guselkumab injections at other visits through Week 100. Data from Week 0 through Week 112 (End of Study) were included.	Guselkumab 100 mg q4w (Through Week 112) n=245 participants at risk Participants received guselkumab 100 milligram (mg) subcutaneous injections every 4 weeks from Week 0 through Week 100. Data from Week 0 through Week 112 (End of Study) were included.
Infections and infestations Dengue Fever	0.00% 0/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.42% 1/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Infections and infestations Diverticulitis	0.00% 0/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.40% 1/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Infections and infestations Herpes Zoster Disseminated	0.00% 0/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.40% 1/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Cardiac disorders Acute Myocardial Infarction	0.00% 0/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.41% 1/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Cardiac disorders Angina Unstable	0.41% 1/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.40% 1/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Cardiac disorders Coronary Artery Disease	0.00% 0/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.40% 1/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.40% 1/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.41% 1/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Cardiac disorders Pericarditis	0.00% 0/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.42% 1/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Endocrine disorders Goitre	0.00% 0/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.84% 2/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Eye disorders Iridocyclitis	0.00% 0/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.40% 1/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Gastrointestinal disorders Diverticular Perforation	0.00% 0/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.41% 1/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Gastrointestinal disorders Gastric Ulcer	0.00% 0/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.41% 1/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Gastrointestinal disorders Inflammatory Bowel Disease	0.41% 1/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Gastrointestinal disorders Pancreatitis Chronic	0.00% 0/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.40% 1/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Gastrointestinal disorders Umbilical Hernia	0.00% 0/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.41% 1/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
General disorders Pyrexia	0.00% 0/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.40% 1/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.40% 1/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Hepatobiliary disorders Cholecystitis Chronic	0.00% 0/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.81% 2/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Hepatobiliary disorders Cholelithiasis	0.00% 0/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.42% 1/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Hepatobiliary disorders Drug-Induced Liver Injury	0.41% 1/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Hepatobiliary disorders Post Cholecystectomy Syndrome	0.00% 0/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.40% 1/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Infections and infestations Acute Hepatitis B	0.00% 0/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.41% 1/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.41% 1/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Infections and infestations Acute Hepatitis C	0.00% 0/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.42% 1/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Infections and infestations Appendicitis	0.00% 0/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.40% 1/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Infections and infestations Complicated Appendicitis	0.00% 0/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.41% 1/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Infections and infestations Cystitis	0.00% 0/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.40% 1/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Infections and infestations Dacryocystitis	0.00% 0/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.40% 1/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Infections and infestations Infective Periostitis	0.00% 0/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.42% 1/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Infections and infestations Influenza	0.00% 0/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.42% 1/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Infections and infestations Medical Device Site Joint Infection	0.00% 0/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.42% 1/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Infections and infestations Meningitis Listeria	0.00% 0/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.42% 1/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Infections and infestations Oophoritis	0.00% 0/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.41% 1/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.41% 1/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Infections and infestations Pneumonia	0.00% 0/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.42% 1/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.81% 2/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.41% 1/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Infections and infestations Pneumonia Influenzal	0.00% 0/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.41% 1/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.41% 1/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Infections and infestations Pneumonia Necrotising	0.00% 0/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.40% 1/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Infections and infestations Tracheitis	0.00% 0/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.42% 1/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Infections and infestations Urinary Tract Infection	0.00% 0/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.40% 1/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Infections and infestations Vaginitis Gardnerella	0.00% 0/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.40% 1/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Infections and infestations Vulvovaginitis Trichomonal	0.00% 0/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.40% 1/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Injury, poisoning and procedural complications Ankle Fracture	0.00% 0/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.40% 1/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	1.2% 3/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.41% 1/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Injury, poisoning and procedural complications Femur Fracture	0.00% 0/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.41% 1/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.41% 1/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Injury, poisoning and procedural complications Lower Limb Fracture	0.00% 0/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.41% 1/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.41% 1/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Injury, poisoning and procedural complications Metal Poisoning	0.00% 0/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.41% 1/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.41% 1/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Injury, poisoning and procedural complications Multiple Injuries	0.00% 0/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.42% 1/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.41% 1/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Injury, poisoning and procedural complications Muscle Rupture	0.00% 0/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.41% 1/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Injury, poisoning and procedural complications Post Procedural Fistula	0.41% 1/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Injury, poisoning and procedural complications Road Traffic Accident	0.00% 0/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.42% 1/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Injury, poisoning and procedural complications Thermal Burn	0.00% 0/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.40% 1/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Metabolism and nutrition disorders Diabetes Mellitus Inadequate Control	0.00% 0/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.41% 1/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Metabolism and nutrition disorders Obesity	0.41% 1/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.40% 1/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Musculoskeletal and connective tissue disorders Costochondritis	0.00% 0/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.42% 1/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Musculoskeletal and connective tissue disorders Foot Deformity	0.00% 0/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.41% 1/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.41% 1/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.84% 2/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.82% 2/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Musculoskeletal and connective tissue disorders Psoriatic Arthropathy	0.00% 0/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.40% 1/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Clear Cell Renal Cell Carcinoma	0.41% 1/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian Adenoma	0.00% 0/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.40% 1/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Nervous system disorders Extrapyramidal Disorder	0.00% 0/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.42% 1/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Nervous system disorders Ischaemic Stroke	0.00% 0/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.41% 1/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.82% 2/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Nervous system disorders Transient Ischaemic Attack	0.00% 0/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.40% 1/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Renal and urinary disorders Calculus Urinary	0.00% 0/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.40% 1/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Renal and urinary disorders Tubulointerstitial Nephritis	0.41% 1/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Reproductive system and breast disorders Cervical Polyp	0.00% 0/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.40% 1/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Reproductive system and breast disorders Dysfunctional Uterine Bleeding	0.00% 0/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.42% 1/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Reproductive system and breast disorders Endometrial Hyperplasia	0.00% 0/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.42% 1/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Reproductive system and breast disorders Endometriosis	0.00% 0/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.40% 1/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Reproductive system and breast disorders Metrorrhagia	0.00% 0/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.42% 1/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.00% 0/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.82% 2/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Respiratory, thoracic and mediastinal disorders Sinus Perforation	0.00% 0/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.41% 1/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Vascular disorders Blue Toe Syndrome	0.00% 0/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.41% 1/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.41% 1/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Vascular disorders Hypertension	0.00% 0/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.40% 1/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Vascular disorders Pelvic Venous Thrombosis	0.00% 0/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.42% 1/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.00% 0/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.

Other adverse events

Measure	Placebo (CP) n=246 participants at risk Participants received placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (CP). Data prior to the first administration of guselkumab, or through the last follow-up visit if the participant did not receive any guselkumab, were included.	Guselkumab 100 mg q8w (CP) n=248 participants at risk Participants received guselkumab 100 milligram (mg) subcutaneous injections at Weeks 0 and 4 then every 8 weeks and placebo matched to guselkumab injections at other visits through Week 20 in the placebo controlled period (CP). Data through Week 24, or through the last follow-up visit if the participant did not receive any study drug at or after Week 24, were included.	Guselkumab 100 mg q4w (CP) n=245 participants at risk Participants received guselkumab 100 milligram (mg) subcutaneous injections every 4 weeks from Week 0 through Week 20 in the placebo controlled period (CP). Data through Week 24, or through the last follow-up visit if the participant did not receive any study drug at or after Week 24, were included.	Placebo to Guselkumab 100 mg q4w (After CP Through Week 112) n=238 participants at risk Participants who received placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (CP) received guselkumab 100 milligram (mg) subcutaneous injections every 4 weeks from Week 24 through Week 100. Data from the first administration of guselkumab through Week 112 (End of Study) were included.	Guselkumab 100 mg q8w (Through Week 112) n=248 participants at risk Participants received guselkumab 100 milligram (mg) subcutaneous injections at Weeks 0 and 4 then every 8 weeks and placebo matched to guselkumab injections at other visits through Week 100. Data from Week 0 through Week 112 (End of Study) were included.	Guselkumab 100 mg q4w (Through Week 112) n=245 participants at risk Participants received guselkumab 100 milligram (mg) subcutaneous injections every 4 weeks from Week 0 through Week 100. Data from Week 0 through Week 112 (End of Study) were included.
Infections and infestations Bronchitis	1.2% 3/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	0.40% 1/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	4.1% 10/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	2.9% 7/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	4.0% 10/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	6.1% 15/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Infections and infestations Nasopharyngitis	3.7% 9/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	4.0% 10/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	4.9% 12/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	3.8% 9/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	10.1% 25/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	8.6% 21/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Infections and infestations Upper Respiratory Tract Infection	3.3% 8/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	2.8% 7/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	5.3% 13/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	7.6% 18/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	9.7% 24/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	8.2% 20/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Investigations Alanine Aminotransferase Increased	4.5% 11/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	6.0% 15/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	9.0% 22/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	4.6% 11/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	11.7% 29/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	12.7% 31/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Investigations Aspartate Aminotransferase Increased	2.4% 6/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	5.6% 14/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	4.5% 11/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	4.2% 10/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	9.3% 23/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	9.4% 23/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Nervous system disorders Headache	0.81% 2/246 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	2.4% 6/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	1.2% 3/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	2.9% 7/238 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	6.5% 16/248 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.	2.9% 7/245 • From baseline after the first administration of study drug through End of Study (up to Week 112) Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.

Additional Information

Head Rheumatology Clinical Development

Janssen Research & Development, LLC

Phone: 844-434-4210

Email: ClinicalTrialDisclosure@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
• Publication restrictions are in place

Restriction type: OTHER