Trial Outcomes & Findings for A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis Including Those Previously Treated With Biologic Anti -Tumor Necrosis Factor (TNF) Alpha Agent(s) (NCT NCT03162796)

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

383 participants

Primary outcome timeframe

Week 24

Results posted on

2021-02-03

Participant Flow

A total of 383 participants were enrolled. Among them, 381 participants received at least one dose of study drug (126 in placebo group, 127 in guselkumab 100 mg q8w group and 128 in guselkumab 100 mg q4w group). One participant was randomized to guselkumab 100 mg q8w but not treated.

One participant was accidentally randomized before completion of screening assessments. Subsequently, this participant screen failed and was later re-screened and randomized using a new participant number.Therefore, this participant was counted twice in the number of participants enrolled, but only once in the number of participants randomized.

Participant milestones

Participant milestones
Measure	Placebo 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 48 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) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Placebo Controlled Period: Week 0 - 24 STARTED	126	127	128
Placebo Controlled Period: Week 0 - 24 COMPLETED	114	123	125
Placebo Controlled Period: Week 0 - 24 NOT COMPLETED	12	4	3
Active Treatment Period: Week 24 - 52 STARTED	114	123	125
Active Treatment Period: Week 24 - 52 COMPLETED	107	116	124
Active Treatment Period: Week 24 - 52 NOT COMPLETED	7	7	1
Safety Follow-up: Week 52 - 60 STARTED	107	116	124
Safety Follow-up: Week 52 - 60 COMPLETED	106	114	123
Safety Follow-up: Week 52 - 60 NOT COMPLETED	1	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo 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 48 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) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Placebo Controlled Period: Week 0 - 24 Other	0	1	1
Placebo Controlled Period: Week 0 - 24 Initiated prohibited medication	1	0	0
Placebo Controlled Period: Week 0 - 24 Death	1	0	0
Placebo Controlled Period: Week 0 - 24 Lost to Follow-up	1	0	0
Placebo Controlled Period: Week 0 - 24 Withdrawal by Subject	3	0	1
Placebo Controlled Period: Week 0 - 24 Lack of Efficacy	4	0	0
Placebo Controlled Period: Week 0 - 24 Adverse Event	2	3	1
Active Treatment Period: Week 24 - 52 Withdrawal by Subject	0	2	0
Active Treatment Period: Week 24 - 52 Lack of Efficacy	4	3	1
Active Treatment Period: Week 24 - 52 Adverse Event	3	2	0
Safety Follow-up: Week 52 - 60 Withdrawal by Subject	1	2	1

Baseline Characteristics

A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis Including Those Previously Treated With Biologic Anti -Tumor Necrosis Factor (TNF) Alpha Agent(s)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=127 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=128 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.	Total n=381 Participants Total of all reporting groups
Age, Continuous	49 years STANDARD_DEVIATION 11.1 • n=5 Participants	48.9 years STANDARD_DEVIATION 11.52 • n=7 Participants	47.4 years STANDARD_DEVIATION 11.59 • n=5 Participants	48.4 years STANDARD_DEVIATION 11.39 • n=4 Participants
Sex: Female, Male Female	65 Participants n=5 Participants	59 Participants n=7 Participants	62 Participants n=5 Participants	186 Participants n=4 Participants
Sex: Female, Male Male	61 Participants n=5 Participants	68 Participants n=7 Participants	66 Participants n=5 Participants	195 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	122 Participants n=5 Participants	124 Participants n=7 Participants	128 Participants n=5 Participants	374 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	3 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	12 Participants n=5 Participants	10 Participants n=7 Participants	7 Participants n=5 Participants	29 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 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	112 Participants n=5 Participants	116 Participants n=7 Participants	121 Participants n=5 Participants	349 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	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Region of Enrollment AUSTRALIA	5 Participants n=5 Participants	8 Participants n=7 Participants	4 Participants n=5 Participants	17 Participants n=4 Participants
Region of Enrollment CANADA	8 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	15 Participants n=4 Participants
Region of Enrollment CZECH REPUBLIC	5 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	12 Participants n=4 Participants
Region of Enrollment GERMANY	3 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	23 Participants n=4 Participants
Region of Enrollment HUNGARY	3 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants	16 Participants n=4 Participants
Region of Enrollment MALAYSIA	5 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	8 Participants n=4 Participants
Region of Enrollment POLAND	37 Participants n=5 Participants	36 Participants n=7 Participants	34 Participants n=5 Participants	107 Participants n=4 Participants
Region of Enrollment RUSSIAN FEDERATION	22 Participants n=5 Participants	19 Participants n=7 Participants	23 Participants n=5 Participants	64 Participants n=4 Participants
Region of Enrollment SOUTH KOREA	3 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants
Region of Enrollment SPAIN	5 Participants n=5 Participants	6 Participants n=7 Participants	1 Participants n=5 Participants	12 Participants n=4 Participants
Region of Enrollment TAIWAN	4 Participants n=5 Participants	7 Participants n=7 Participants	5 Participants n=5 Participants	16 Participants n=4 Participants
Region of Enrollment UKRAINE	19 Participants n=5 Participants	22 Participants n=7 Participants	29 Participants n=5 Participants	70 Participants n=4 Participants
Region of Enrollment UNITED STATES	7 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	17 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 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

Outcome measures
Measure	Placebo 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=127 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=128 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24	22.2 percentage of participants	52.0 percentage of participants	59.4 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

Outcome measures
Measure	Placebo 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=127 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=128 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24	-0.0743 units on a scale Interval -0.1605 to 0.0119	-0.3225 units on a scale Interval -0.4082 to -0.2369	-0.3968 units on a scale Interval -0.4825 to -0.3112

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

Outcome measures
Measure	Placebo 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=127 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=128 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 50 Response at Week 24	8.7 percentage of participants	29.9 percentage of participants	35.9 percentage of participants

SECONDARY outcome

Timeframe: Week 24

Population: FAS1 among the participants with \>=3% BSA psoriatic involvement and an IGA score of \>=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

Outcome measures
Measure	Placebo 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=82 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=89 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Percentage of Participants With Psoriasis Response of IGA (Score: 0[Cleared] or 1[Minimal] and >=2 Grade Reduction From Baseline) at Week 24 Among Participants With >=3% Body Surface Area (BSA) Psoriatic Involvement and IGA Score of >=2 (Mild) at Baseline	15.4 percentage of participants	57.3 percentage of participants	75.3 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 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=indicating no difficulty, 3=indicating inability to perform task in that area), and C-reactive protein (CRP).

Outcome measures

Outcome measures
Measure	Placebo 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=127 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=128 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 16	25.4 percentage of participants	52.0 percentage of participants	60.2 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 MAR and imputed using 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

Outcome measures
Measure	Placebo 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=127 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=128 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Change From Baseline in Disease Activity Score (DAS28) (C-reactive Protein [CRP]) Score at Week 24	-0.70 units on a scale Interval -0.89 to -0.51	-1.43 units on a scale Interval -1.61 to -1.24	-1.61 units on a scale Interval -1.8 to -1.42

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

Outcome measures
Measure	Placebo 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=127 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=128 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Percentage of Participants Who Achieve an American College of Rheumatology (ACR) 70 Response at Week 24	5.6 percentage of participants	11.8 percentage of participants	20.3 percentage of participants

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

Outcome measures
Measure	Placebo 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=127 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=128 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 50 Response at Week 16	12.7 percentage of participants	22.8 percentage of participants	26.6 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 MAR and imputed using 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

Outcome measures
Measure	Placebo 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=127 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=128 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24	1.96 units on a scale Interval 0.69 to 3.24	6.10 units on a scale Interval 4.83 to 7.37	6.87 units on a scale Interval 5.6 to 8.14

SECONDARY outcome

Timeframe: Week 24

Population: Analysis population is FAS1 among the participants with enthesitis (LEI) at baseline. Participants who achieved resolution of enthesitis 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.

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 greater than (\>) 0.

Outcome measures

Outcome measures
Measure	Placebo n=77 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=72 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=73 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Percentage of Participants With Resolution of Enthesitis at Week 24 Among the Participants With Enthesitis at Baseline	27.3 percentage of participants	40.3 percentage of participants	47.9 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Analysis population is FAS1 among the participants with enthesitis (LEI) at baseline. Data after meeting one or more TF criteria were imputed as no change from baseline. Missing data were assumed to be MAR and imputed using MI.

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 indicates improvement of enthesitis.

Outcome measures

Outcome measures
Measure	Placebo n=77 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=72 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=73 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Change From Baseline in Enthesitis Score (Based on LEI) at Week 24 Among the Participants With Enthesitis at Baseline	-1.01 units on a scale Interval -1.37 to -0.66	-1.35 units on a scale Interval -1.72 to -0.98	-1.75 units on a scale Interval -2.13 to -1.38

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 MAR and imputed using 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

Outcome measures
Measure	Placebo 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=127 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=128 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Change From Baseline in 36-Item Short Form Health Survey (SF-36) Mental Component Summary (MCS) Score at Week 24	2.37 units on a scale Interval 0.93 to 3.81	3.20 units on a scale Interval 1.78 to 4.63	3.60 units on a scale Interval 2.17 to 5.02

SECONDARY outcome

Timeframe: Week 24

Population: Analysis population is FAS1 among the participants with dactylitis at baseline. Participants who achieved resolution of dactylitis 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.

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

Outcome measures
Measure	Placebo n=55 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=49 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=38 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Percentage of Participants With Resolution of Dactylitis at Week 24 Among the Participants With Dactylitis at Baseline	49.1 percentage of participants	65.3 percentage of participants	63.2 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Analysis population is FAS1 among the participants with dactylitis at baseline. Data after meeting one or more TF criteria were imputed as no change from baseline. Missing data were assumed to be MAR and imputed using MI.

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 change from baseline indicates improvement in dactylitis.

Outcome measures

Outcome measures
Measure	Placebo n=55 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=49 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=38 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Change From Baseline in Dactylitis Scores at Week 24 Among the Participants With Dactylitis at Baseline	-4.30 units on a scale Interval -5.96 to -2.63	-6.11 units on a scale Interval -7.81 to -4.41	-5.82 units on a scale Interval -7.82 to -3.83

SECONDARY outcome

Timeframe: Weeks 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 treatment failure (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 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

Outcome measures
Measure	Placebo 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=127 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=128 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Percentage of Participants Who Achieved ACR 20 Response by Visit Over Time Through Week 24 Week 4	7.9 percentage of participants	15.7 percentage of participants	20.3 percentage of participants
Percentage of Participants Who Achieved ACR 20 Response by Visit Over Time Through Week 24 Week 8	18.3 percentage of participants	36.2 percentage of participants	39.1 percentage of participants
Percentage of Participants Who Achieved ACR 20 Response by Visit Over Time Through Week 24 Week 12	27.0 percentage of participants	43.3 percentage of participants	53.1 percentage of participants
Percentage of Participants Who Achieved ACR 20 Response by Visit Over Time Through Week 24 Week 16	25.4 percentage of participants	52.0 percentage of participants	60.2 percentage of participants
Percentage of Participants Who Achieved ACR 20 Response by Visit Over Time Through Week 24 Week 20	30.2 percentage of participants	51.2 percentage of participants	62.5 percentage of participants
Percentage of Participants Who Achieved ACR 20 Response by Visit Over Time Through Week 24 Week 24	22.2 percentage of participants	52.0 percentage of participants	59.4 percentage of participants

SECONDARY outcome

Timeframe: Weeks 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 treatment failure (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 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

Outcome measures
Measure	Placebo 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=127 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=128 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Percentage of Participants Who Achieved ACR 50 Response by Visit Over Time Through Week 24 Week 4	2.4 percentage of participants	1.6 percentage of participants	3.1 percentage of participants
Percentage of Participants Who Achieved ACR 50 Response by Visit Over Time Through Week 24 Week 8	7.9 percentage of participants	7.9 percentage of participants	10.9 percentage of participants
Percentage of Participants Who Achieved ACR 50 Response by Visit Over Time Through Week 24 Week 12	10.3 percentage of participants	20.5 percentage of participants	24.2 percentage of participants
Percentage of Participants Who Achieved ACR 50 Response by Visit Over Time Through Week 24 Week 16	12.7 percentage of participants	22.8 percentage of participants	26.6 percentage of participants
Percentage of Participants Who Achieved ACR 50 Response by Visit Over Time Through Week 24 Week 20	13.5 percentage of participants	29.1 percentage of participants	37.5 percentage of participants
Percentage of Participants Who Achieved ACR 50 Response by Visit Over Time Through Week 24 Week 24	8.7 percentage of participants	29.9 percentage of participants	35.9 percentage of participants

SECONDARY outcome

Timeframe: Weeks 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 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

Outcome measures
Measure	Placebo 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=127 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=128 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Percentage of Participants Who Achieved ACR 70 Response by Visit Over Time Through Week 24 Week 4	0 percentage of participants	0.8 percentage of participants	0 percentage of participants
Percentage of Participants Who Achieved ACR 70 Response by Visit Over Time Through Week 24 Week 8	1.6 percentage of participants	3.1 percentage of participants	2.3 percentage of participants
Percentage of Participants Who Achieved ACR 70 Response by Visit Over Time Through Week 24 Week 12	4.8 percentage of participants	7.1 percentage of participants	6.3 percentage of participants
Percentage of Participants Who Achieved ACR 70 Response by Visit Over Time Through Week 24 Week 16	5.6 percentage of participants	7.9 percentage of participants	7.8 percentage of participants
Percentage of Participants Who Achieved ACR 70 Response by Visit Over Time Through Week 24 Week 20	7.1 percentage of participants	11.8 percentage of participants	17.2 percentage of participants
Percentage of Participants Who Achieved ACR 70 Response by Visit Over Time Through Week 24 Week 24	5.6 percentage of participants	11.8 percentage of participants	20.3 percentage of participants

SECONDARY outcome

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

Population: Analysis population is FAS1. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

ACR components including swollen joint count (66 joints) and tender joint count (68 joints) were measured.

Outcome measures

Outcome measures
Measure	Placebo 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=127 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=128 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
ACR Components- Swollen Joint Count and Tender Joint Count Through Week 24 Week 20: Tender Joint Count	13.4 joints Standard Deviation 13.02	9.9 joints Standard Deviation 12.53	7.9 joints Standard Deviation 9.54
ACR Components- Swollen Joint Count and Tender Joint Count Through Week 24 Week 4: Swollen Joint Count	8.0 joints Standard Deviation 7.71	7.7 joints Standard Deviation 7.89	5.7 joints Standard Deviation 4.89
ACR Components- Swollen Joint Count and Tender Joint Count Through Week 24 Week 8: Swollen Joint Count	6.6 joints Standard Deviation 5.83	6.2 joints Standard Deviation 9.36	4.4 joints Standard Deviation 5.22
ACR Components- Swollen Joint Count and Tender Joint Count Through Week 24 Week 12: Swollen Joint Count	6.1 joints Standard Deviation 6.41	4.5 joints Standard Deviation 6.63	3.5 joints Standard Deviation 5.60
ACR Components- Swollen Joint Count and Tender Joint Count Through Week 24 Week 16: Swollen Joint Count	5.9 joints Standard Deviation 6.09	3.8 joints Standard Deviation 5.15	2.7 joints Standard Deviation 4.25
ACR Components- Swollen Joint Count and Tender Joint Count Through Week 24 Week 20: Swollen Joint Count	5.2 joints Standard Deviation 5.72	4.0 joints Standard Deviation 6.28	2.7 joints Standard Deviation 4.87
ACR Components- Swollen Joint Count and Tender Joint Count Through Week 24 Week 24: Swollen Joint Count	4.9 joints Standard Deviation 6.14	3.8 joints Standard Deviation 6.53	2.8 joints Standard Deviation 5.27
ACR Components- Swollen Joint Count and Tender Joint Count Through Week 24 Week 4: Tender Joint Count	17.0 joints Standard Deviation 13.81	16.3 joints Standard Deviation 14.11	14.4 joints Standard Deviation 11.85
ACR Components- Swollen Joint Count and Tender Joint Count Through Week 24 Week 8: Tender Joint Count	15.8 joints Standard Deviation 13.68	13.5 joints Standard Deviation 13.86	12.2 joints Standard Deviation 11.53
ACR Components- Swollen Joint Count and Tender Joint Count Through Week 24 Week 12: Tender Joint Count	15.1 joints Standard Deviation 14.21	11.5 joints Standard Deviation 13.16	9.7 joints Standard Deviation 11.14
ACR Components- Swollen Joint Count and Tender Joint Count Through Week 24 Week 16: Tender Joint Count	15.5 joints Standard Deviation 13.61	10.3 joints Standard Deviation 12.06	9.0 joints Standard Deviation 10.29
ACR Components- Swollen Joint Count and Tender Joint Count Through Week 24 Week 24: Tender Joint Count	13.2 joints Standard Deviation 12.09	9.9 joints Standard Deviation 12.82	8.4 joints Standard Deviation 10.47

SECONDARY outcome

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

Population: Analysis population is FAS1. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

ACR components included 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 (PtGA) of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment (PGA) of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis).

Outcome measures

Outcome measures
Measure	Placebo 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=127 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=128 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
ACR Components- Patient's Assessment of Pain, Patient's Global Assessment of Disease Activity, Physician's Global Assessment of Disease Activity Through Week 24 Week 16: PtGA of Disease Activity	5.12 millimeters Standard Deviation 2.379	4.59 millimeters Standard Deviation 2.541	3.96 millimeters Standard Deviation 2.458
ACR Components- Patient's Assessment of Pain, Patient's Global Assessment of Disease Activity, Physician's Global Assessment of Disease Activity Through Week 24 Week 4: Patient's Assessment of Pain	5.74 millimeters Standard Deviation 2.296	5.49 millimeters Standard Deviation 2.159	5.18 millimeters Standard Deviation 2.224
ACR Components- Patient's Assessment of Pain, Patient's Global Assessment of Disease Activity, Physician's Global Assessment of Disease Activity Through Week 24 Week 8: Patient's Assessment of Pain	5.06 millimeters Standard Deviation 2.257	4.90 millimeters Standard Deviation 2.310	4.54 millimeters Standard Deviation 2.397
ACR Components- Patient's Assessment of Pain, Patient's Global Assessment of Disease Activity, Physician's Global Assessment of Disease Activity Through Week 24 Week 12: Patient's Assessment of Pain	4.96 millimeters Standard Deviation 2.355	4.35 millimeters Standard Deviation 2.503	4.09 millimeters Standard Deviation 2.346
ACR Components- Patient's Assessment of Pain, Patient's Global Assessment of Disease Activity, Physician's Global Assessment of Disease Activity Through Week 24 Week 16: Patient's Assessment of Pain	5.01 millimeters Standard Deviation 2.417	4.25 millimeters Standard Deviation 2.471	3.85 millimeters Standard Deviation 2.462
ACR Components- Patient's Assessment of Pain, Patient's Global Assessment of Disease Activity, Physician's Global Assessment of Disease Activity Through Week 24 Week 20: Patient's Assessment of Pain	4.98 millimeters Standard Deviation 2.497	4.00 millimeters Standard Deviation 2.481	3.51 millimeters Standard Deviation 2.409
ACR Components- Patient's Assessment of Pain, Patient's Global Assessment of Disease Activity, Physician's Global Assessment of Disease Activity Through Week 24 Week 24: Patient's Assessment of Pain	5.09 millimeters Standard Deviation 2.379	3.82 millimeters Standard Deviation 2.470	3.52 millimeters Standard Deviation 2.502
ACR Components- Patient's Assessment of Pain, Patient's Global Assessment of Disease Activity, Physician's Global Assessment of Disease Activity Through Week 24 Week 4: PtGA of Disease Activity	5.86 millimeters Standard Deviation 2.281	5.80 millimeters Standard Deviation 2.181	5.36 millimeters Standard Deviation 2.200
ACR Components- Patient's Assessment of Pain, Patient's Global Assessment of Disease Activity, Physician's Global Assessment of Disease Activity Through Week 24 Week 8: PtGA of Disease Activity	5.26 millimeters Standard Deviation 2.271	4.99 millimeters Standard Deviation 2.381	4.82 millimeters Standard Deviation 2.384
ACR Components- Patient's Assessment of Pain, Patient's Global Assessment of Disease Activity, Physician's Global Assessment of Disease Activity Through Week 24 Week 12: PtGA of Disease Activity	5.13 millimeters Standard Deviation 2.398	4.46 millimeters Standard Deviation 2.459	4.18 millimeters Standard Deviation 2.441
ACR Components- Patient's Assessment of Pain, Patient's Global Assessment of Disease Activity, Physician's Global Assessment of Disease Activity Through Week 24 Week 20: PtGA of Disease Activity	5.08 millimeters Standard Deviation 2.596	4.21 millimeters Standard Deviation 2.604	3.57 millimeters Standard Deviation 2.443
ACR Components- Patient's Assessment of Pain, Patient's Global Assessment of Disease Activity, Physician's Global Assessment of Disease Activity Through Week 24 Week 24: PtGA of Disease Activity	5.19 millimeters Standard Deviation 2.419	4.03 millimeters Standard Deviation 2.603	3.48 millimeters Standard Deviation 2.412
ACR Components- Patient's Assessment of Pain, Patient's Global Assessment of Disease Activity, Physician's Global Assessment of Disease Activity Through Week 24 Week 4: PGA of Disease Activity	5.53 millimeters Standard Deviation 1.986	4.94 millimeters Standard Deviation 1.977	4.72 millimeters Standard Deviation 1.955
ACR Components- Patient's Assessment of Pain, Patient's Global Assessment of Disease Activity, Physician's Global Assessment of Disease Activity Through Week 24 Week 8: PGA of Disease Activity	4.79 millimeters Standard Deviation 2.197	3.88 millimeters Standard Deviation 2.299	3.63 millimeters Standard Deviation 2.035
ACR Components- Patient's Assessment of Pain, Patient's Global Assessment of Disease Activity, Physician's Global Assessment of Disease Activity Through Week 24 Week 12: PGA of Disease Activity	4.31 millimeters Standard Deviation 2.196	3.47 millimeters Standard Deviation 1.992	3.08 millimeters Standard Deviation 2.031
ACR Components- Patient's Assessment of Pain, Patient's Global Assessment of Disease Activity, Physician's Global Assessment of Disease Activity Through Week 24 Week 16: PGA of Disease Activity	4.31 millimeters Standard Deviation 2.296	3.39 millimeters Standard Deviation 2.260	2.73 millimeters Standard Deviation 2.022
ACR Components- Patient's Assessment of Pain, Patient's Global Assessment of Disease Activity, Physician's Global Assessment of Disease Activity Through Week 24 Week 20: PGA of Disease Activity	3.96 millimeters Standard Deviation 2.367	2.90 millimeters Standard Deviation 2.132	2.44 millimeters Standard Deviation 1.780
ACR Components- Patient's Assessment of Pain, Patient's Global Assessment of Disease Activity, Physician's Global Assessment of Disease Activity Through Week 24 Week 24: PGA of Disease Activity	4.07 millimeters Standard Deviation 2.361	2.81 millimeters Standard Deviation 2.169	2.34 millimeters Standard Deviation 1.889

SECONDARY outcome

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

Population: Analysis population is FAS1. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

ACR component including CRP was measured.

Outcome measures

Outcome measures
Measure	Placebo 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=127 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=128 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
ACR Component- C-reactive Protein (CRP) Through Week 24 Week 16	1.143 milligrams per deciliter (mg/dL) Standard Deviation 1.6005	0.996 milligrams per deciliter (mg/dL) Standard Deviation 1.5296	0.592 milligrams per deciliter (mg/dL) Standard Deviation 0.7861
ACR Component- C-reactive Protein (CRP) Through Week 24 Week 4	1.220 milligrams per deciliter (mg/dL) Standard Deviation 1.5753	1.159 milligrams per deciliter (mg/dL) Standard Deviation 1.7641	0.785 milligrams per deciliter (mg/dL) Standard Deviation 1.1917
ACR Component- C-reactive Protein (CRP) Through Week 24 Week 8	1.184 milligrams per deciliter (mg/dL) Standard Deviation 1.8722	1.059 milligrams per deciliter (mg/dL) Standard Deviation 1.4736	0.720 milligrams per deciliter (mg/dL) Standard Deviation 1.2637
ACR Component- C-reactive Protein (CRP) Through Week 24 Week 12	1.138 milligrams per deciliter (mg/dL) Standard Deviation 1.5889	0.936 milligrams per deciliter (mg/dL) Standard Deviation 1.3470	0.629 milligrams per deciliter (mg/dL) Standard Deviation 0.7882
ACR Component- C-reactive Protein (CRP) Through Week 24 Week 20	1.105 milligrams per deciliter (mg/dL) Standard Deviation 1.6401	0.941 milligrams per deciliter (mg/dL) Standard Deviation 1.5067	0.592 milligrams per deciliter (mg/dL) Standard Deviation 0.8831
ACR Component- C-reactive Protein (CRP) Through Week 24 Week 24	1.319 milligrams per deciliter (mg/dL) Standard Deviation 3.0033	0.894 milligrams per deciliter (mg/dL) Standard Deviation 1.5386	0.633 milligrams per deciliter (mg/dL) Standard Deviation 1.0522

SECONDARY outcome

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

Population: Analysis population is FAS1. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Patient's assessment of physical function was measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI). 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

Outcome measures
Measure	Placebo 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=127 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=128 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
ACR Component- Patient's Assessment of Physical Function as Assessed by HAQ-DI Scale Score at Weeks 4, 8, 12, 16, 20 and 24 Week 4	1.2188 units on a scale Standard Deviation 0.67806	1.1371 units on a scale Standard Deviation 0.59755	0.9824 units on a scale Standard Deviation 0.65278
ACR Component- Patient's Assessment of Physical Function as Assessed by HAQ-DI Scale Score at Weeks 4, 8, 12, 16, 20 and 24 Week 8	1.1331 units on a scale Standard Deviation 0.66928	1.0188 units on a scale Standard Deviation 0.61463	0.9150 units on a scale Standard Deviation 0.65488
ACR Component- Patient's Assessment of Physical Function as Assessed by HAQ-DI Scale Score at Weeks 4, 8, 12, 16, 20 and 24 Week 12	1.1169 units on a scale Standard Deviation 0.63813	0.9831 units on a scale Standard Deviation 0.64058	0.8012 units on a scale Standard Deviation 0.63060
ACR Component- Patient's Assessment of Physical Function as Assessed by HAQ-DI Scale Score at Weeks 4, 8, 12, 16, 20 and 24 Week 16	1.1035 units on a scale Standard Deviation 0.65372	0.9375 units on a scale Standard Deviation 0.65845	0.7776 units on a scale Standard Deviation 0.66011
ACR Component- Patient's Assessment of Physical Function as Assessed by HAQ-DI Scale Score at Weeks 4, 8, 12, 16, 20 and 24 Week 20	1.1049 units on a scale Standard Deviation 0.67838	0.8730 units on a scale Standard Deviation 0.62347	0.7619 units on a scale Standard Deviation 0.66491
ACR Component- Patient's Assessment of Physical Function as Assessed by HAQ-DI Scale Score at Weeks 4, 8, 12, 16, 20 and 24 Week 24	1.1133 units on a scale Standard Deviation 0.69279	0.8770 units on a scale Standard Deviation 0.60691	0.7264 units on a scale Standard Deviation 0.63225

SECONDARY outcome

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

Population: Analysis population is FAS1. 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; 0-100 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

Outcome measures
Measure	Placebo 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=127 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=128 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Percent Change From Baseline in ACR Components at Weeks 4, 8, 12, 16, 20 and 24 Week 16: CRP	82.057 percent change Standard Deviation 734.6577	7.139 percent change Standard Deviation 134.6682	2.759 percent change Standard Deviation 208.7305
Percent Change From Baseline in ACR Components at Weeks 4, 8, 12, 16, 20 and 24 Week 20: CRP	5.768 percent change Standard Deviation 98.6914	-11.151 percent change Standard Deviation 84.9807	-14.684 percent change Standard Deviation 98.0041
Percent Change From Baseline in ACR Components at Weeks 4, 8, 12, 16, 20 and 24 Week 4: Swollen Joint Count	-22.4 percent change Standard Deviation 49.78	-27.5 percent change Standard Deviation 42.92	-29.3 percent change Standard Deviation 50.85
Percent Change From Baseline in ACR Components at Weeks 4, 8, 12, 16, 20 and 24 Week 8: Swollen Joint Count	-29.4 percent change Standard Deviation 50.57	-45.3 percent change Standard Deviation 66.29	-46.5 percent change Standard Deviation 53.81
Percent Change From Baseline in ACR Components at Weeks 4, 8, 12, 16, 20 and 24 Week 12: Swollen Joint Count	-38.1 percent change Standard Deviation 55.69	-60.0 percent change Standard Deviation 48.23	-61.1 percent change Standard Deviation 42.62
Percent Change From Baseline in ACR Components at Weeks 4, 8, 12, 16, 20 and 24 Week 16: Swollen Joint Count	-36.6 percent change Standard Deviation 56.25	-65.8 percent change Standard Deviation 40.42	-71.3 percent change Standard Deviation 34.69
Percent Change From Baseline in ACR Components at Weeks 4, 8, 12, 16, 20 and 24 Week 20: Swollen Joint Count	-44.4 percent change Standard Deviation 54.01	-66.2 percent change Standard Deviation 38.24	-71.0 percent change Standard Deviation 40.88
Percent Change From Baseline in ACR Components at Weeks 4, 8, 12, 16, 20 and 24 Week 24: Swollen Joint Count	-49.5 percent change Standard Deviation 45.66	-66.6 percent change Standard Deviation 47.09	-73.3 percent change Standard Deviation 37.95
Percent Change From Baseline in ACR Components at Weeks 4, 8, 12, 16, 20 and 24 Week 4: Tender Joint Count	-15.4 percent change Standard Deviation 36.11	-22.2 percent change Standard Deviation 36.99	-17.2 percent change Standard Deviation 50.26
Percent Change From Baseline in ACR Components at Weeks 4, 8, 12, 16, 20 and 24 Week 8: Tender Joint Count	-21.4 percent change Standard Deviation 41.36	-35.7 percent change Standard Deviation 47.45	-31.4 percent change Standard Deviation 47.13
Percent Change From Baseline in ACR Components at Weeks 4, 8, 12, 16, 20 and 24 Week 12: Tender Joint Count	-24.5 percent change Standard Deviation 50.74	-48.0 percent change Standard Deviation 40.24	-47.9 percent change Standard Deviation 38.76
Percent Change From Baseline in ACR Components at Weeks 4, 8, 12, 16, 20 and 24 Week 16: Tender Joint Count	-19.9 percent change Standard Deviation 50.84	-52.6 percent change Standard Deviation 36.33	-49.2 percent change Standard Deviation 57.97
Percent Change From Baseline in ACR Components at Weeks 4, 8, 12, 16, 20 and 24 Week 20: Tender Joint Count	-30.8 percent change Standard Deviation 53.79	-55.4 percent change Standard Deviation 40.17	-59.4 percent change Standard Deviation 35.91
Percent Change From Baseline in ACR Components at Weeks 4, 8, 12, 16, 20 and 24 Week 24: Tender Joint Count	-29.1 percent change Standard Deviation 53.54	-53.7 percent change Standard Deviation 45.12	-56.0 percent change Standard Deviation 41.76
Percent Change From Baseline in ACR Components at Weeks 4, 8, 12, 16, 20 and 24 Week 4: Patient's Assessment of Pain	2.98 percent change Standard Deviation 38.337	-2.41 percent change Standard Deviation 43.139	-9.12 percent change Standard Deviation 37.068
Percent Change From Baseline in ACR Components at Weeks 4, 8, 12, 16, 20 and 24 Week 8: Patient's Assessment of Pain	-7.41 percent change Standard Deviation 42.846	-12.18 percent change Standard Deviation 46.920	-19.41 percent change Standard Deviation 45.862
Percent Change From Baseline in ACR Components at Weeks 4, 8, 12, 16, 20 and 24 Week 12: Patient's Assessment of Pain	-7.82 percent change Standard Deviation 49.910	-22.74 percent change Standard Deviation 45.048	-27.28 percent change Standard Deviation 42.305
Percent Change From Baseline in ACR Components at Weeks 4, 8, 12, 16, 20 and 24 Week 16: Patient's Assessment of Pain	-7.86 percent change Standard Deviation 47.980	-25.45 percent change Standard Deviation 47.860	-29.74 percent change Standard Deviation 53.817
Percent Change From Baseline in ACR Components at Weeks 4, 8, 12, 16, 20 and 24 Week 20: Patient's Assessment of Pain	-8.31 percent change Standard Deviation 54.287	-29.36 percent change Standard Deviation 46.581	-38.45 percent change Standard Deviation 46.235
Percent Change From Baseline in ACR Components at Weeks 4, 8, 12, 16, 20 and 24 Week 24: Patient's Assessment of Pain	-5.35 percent change Standard Deviation 53.599	-32.65 percent change Standard Deviation 45.343	-38.97 percent change Standard Deviation 43.873
Percent Change From Baseline in ACR Components at Weeks 4, 8, 12, 16, 20 and 24 Week 4: PtGA of Disease Activity	0.06 percent change Standard Deviation 37.022	-9.57 percent change Standard Deviation 30.374	-2.82 percent change Standard Deviation 58.438
Percent Change From Baseline in ACR Components at Weeks 4, 8, 12, 16, 20 and 24 Week 8: PtGA of Disease Activity	-9.06 percent change Standard Deviation 43.197	-20.08 percent change Standard Deviation 45.707	-14.95 percent change Standard Deviation 46.672
Percent Change From Baseline in ACR Components at Weeks 4, 8, 12, 16, 20 and 24 Week 12: PtGA of Disease Activity	-10.00 percent change Standard Deviation 49.346	-28.38 percent change Standard Deviation 40.863	-26.84 percent change Standard Deviation 48.800
Percent Change From Baseline in ACR Components at Weeks 4, 8, 12, 16, 20 and 24 Week 16: PtGA of Disease Activity	-8.56 percent change Standard Deviation 55.279	-26.93 percent change Standard Deviation 42.999	-30.16 percent change Standard Deviation 47.486
Percent Change From Baseline in ACR Components at Weeks 4, 8, 12, 16, 20 and 24 Week 20: PtGA of Disease Activity	-11.67 percent change Standard Deviation 54.531	-34.61 percent change Standard Deviation 40.905	-38.76 percent change Standard Deviation 43.118
Percent Change From Baseline in ACR Components at Weeks 4, 8, 12, 16, 20 and 24 Week 24: PtGA of Disease Activity	-4.91 percent change Standard Deviation 65.728	-37.16 percent change Standard Deviation 39.760	-40.32 percent change Standard Deviation 42.037
Percent Change From Baseline in ACR Components at Weeks 4, 8, 12, 16, 20 and 24 Week 4: PGA of Disease Activity	-10.50 percent change Standard Deviation 30.144	-17.83 percent change Standard Deviation 34.370	-22.42 percent change Standard Deviation 34.627
Percent Change From Baseline in ACR Components at Weeks 4, 8, 12, 16, 20 and 24 Week 8: PGA of Disease Activity	-20.87 percent change Standard Deviation 38.908	-36.57 percent change Standard Deviation 34.906	-41.05 percent change Standard Deviation 31.682
Percent Change From Baseline in ACR Components at Weeks 4, 8, 12, 16, 20 and 24 Week 12: PGA of Disease Activity	-30.47 percent change Standard Deviation 32.894	-40.61 percent change Standard Deviation 37.367	-48.87 percent change Standard Deviation 35.082
Percent Change From Baseline in ACR Components at Weeks 4, 8, 12, 16, 20 and 24 Week 16: PGA of Disease Activity	-29.42 percent change Standard Deviation 36.058	-45.04 percent change Standard Deviation 36.363	-55.36 percent change Standard Deviation 32.848
Percent Change From Baseline in ACR Components at Weeks 4, 8, 12, 16, 20 and 24 Week 20: PGA of Disease Activity	-36.48 percent change Standard Deviation 35.490	-51.88 percent change Standard Deviation 34.491	-59.57 percent change Standard Deviation 30.353
Percent Change From Baseline in ACR Components at Weeks 4, 8, 12, 16, 20 and 24 Week 24: PGA of Disease Activity	-33.95 percent change Standard Deviation 34.349	-53.43 percent change Standard Deviation 37.305	-61.39 percent change Standard Deviation 31.234
Percent Change From Baseline in ACR Components at Weeks 4, 8, 12, 16, 20 and 24 Week 4: HAQ-DI Score	4.3521 percent change Standard Deviation 61.86548	-0.4964 percent change Standard Deviation 54.63888	-5.9245 percent change Standard Deviation 53.44204
Percent Change From Baseline in ACR Components at Weeks 4, 8, 12, 16, 20 and 24 Week 8: HAQ-DI Score	-3.3329 percent change Standard Deviation 48.15101	-9.1556 percent change Standard Deviation 65.76295	-11.3467 percent change Standard Deviation 69.07565
Percent Change From Baseline in ACR Components at Weeks 4, 8, 12, 16, 20 and 24 Week 12: HAQ-DI Score	-2.1600 percent change Standard Deviation 88.42239	-13.1115 percent change Standard Deviation 69.57297	-21.6242 percent change Standard Deviation 65.32053
Percent Change From Baseline in ACR Components at Weeks 4, 8, 12, 16, 20 and 24 Week 16: HAQ-DI Score	-3.2447 percent change Standard Deviation 109.78825	-19.5421 percent change Standard Deviation 55.80512	-27.7444 percent change Standard Deviation 68.28273
Percent Change From Baseline in ACR Components at Weeks 4, 8, 12, 16, 20 and 24 Week 20: HAQ-DI Score	-10.5259 percent change Standard Deviation 44.67386	-23.6139 percent change Standard Deviation 65.27566	-26.2478 percent change Standard Deviation 74.38446
Percent Change From Baseline in ACR Components at Weeks 4, 8, 12, 16, 20 and 24 Week 24: HAQ-DI Score	-7.3745 percent change Standard Deviation 61.62081	-8.7950 percent change Standard Deviation 148.19861	-31.1750 percent change Standard Deviation 72.70079
Percent Change From Baseline in ACR Components at Weeks 4, 8, 12, 16, 20 and 24 Week 4: CRP	9.972 percent change Standard Deviation 66.9599	-4.060 percent change Standard Deviation 76.1801	-1.054 percent change Standard Deviation 102.5692
Percent Change From Baseline in ACR Components at Weeks 4, 8, 12, 16, 20 and 24 :Week 8: CRP	10.402 percent change Standard Deviation 83.4766	5.403 percent change Standard Deviation 111.6889	11.791 percent change Standard Deviation 273.1510
Percent Change From Baseline in ACR Components at Weeks 4, 8, 12, 16, 20 and 24 Week 12: CRP	9.295 percent change Standard Deviation 94.9020	-2.507 percent change Standard Deviation 98.4549	-7.908 percent change Standard Deviation 114.4983
Percent Change From Baseline in ACR Components at Weeks 4, 8, 12, 16, 20 and 24 Week 24: CRP	31.628 percent change Standard Deviation 239.7722	-7.404 percent change Standard Deviation 101.4807	-6.112 percent change Standard Deviation 148.2088

SECONDARY outcome

Timeframe: Baseline, Week 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 MAR and imputed using 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

Outcome measures
Measure	Placebo 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=127 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=128 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Change From Baseline in HAQ-DI Score at Weeks 4, 8, 12, 16, 20 and 24 Week 4	0.0043 units on a scale Interval -0.0562 to 0.0647	-0.0571 units on a scale Interval -0.1173 to 0.0031	-0.1095 units on a scale Interval -0.1695 to -0.0494
Change From Baseline in HAQ-DI Score at Weeks 4, 8, 12, 16, 20 and 24 Week 8	-0.0781 units on a scale Interval -0.1498 to -0.0064	-0.1711 units on a scale Interval -0.2423 to -0.0999	-0.1907 units on a scale Interval -0.2619 to -0.1194
Change From Baseline in HAQ-DI Score at Weeks 4, 8, 12, 16, 20 and 24 Week 12	-0.1013 units on a scale Interval -0.1783 to -0.0243	-0.2174 units on a scale Interval -0.2938 to -0.141	-0.3209 units on a scale Interval -0.3973 to -0.2444
Change From Baseline in HAQ-DI Score at Weeks 4, 8, 12, 16, 20 and 24 Week 16	-0.1131 units on a scale Interval -0.1955 to -0.0307	-0.2620 units on a scale Interval -0.3438 to -0.1802	-0.3393 units on a scale Interval -0.4211 to -0.2575
Change From Baseline in HAQ-DI Score at Weeks 4, 8, 12, 16, 20 and 24 Week 20	-0.1079 units on a scale Interval -0.1935 to -0.0223	-0.3293 units on a scale Interval -0.4143 to -0.2443	-0.3708 units on a scale Interval -0.4558 to -0.2858
Change From Baseline in HAQ-DI Score at Weeks 4, 8, 12, 16, 20 and 24 Week 24	-0.0743 units on a scale Interval -0.1605 to -0.0119	-0.3225 units on a scale Interval -0.4082 to -0.2369	-0.3968 units on a scale Interval -0.4825 to -0.3112

SECONDARY outcome

Timeframe: Week 4, 8, 12, 16, 20 and 24

Population: FAS1 among the participants with HAQ-DI Score \>=0.35 at baseline. Participants with HAQ-DI \>=0.35 improvement from baseline at specific timepoint and did not meet any TF criteria before, 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 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 and a decrease of 0.35 from baseline in HAQ-DI score indicates a meaningful improvement.

Outcome measures

Outcome measures
Measure	Placebo n=110 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=112 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=110 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Percentage of Participants Who Achieved a Clinically Meaningful Improvement (>=0.35 Improvement From Baseline) in HAQ-DI Score by Visit Over Time Through Week 24 Among Participants With HAQ-DI Score >=0.35 at Baseline Week 8	25.5 percentage of participants	40.2 percentage of participants	38.2 percentage of participants
Percentage of Participants Who Achieved a Clinically Meaningful Improvement (>=0.35 Improvement From Baseline) in HAQ-DI Score by Visit Over Time Through Week 24 Among Participants With HAQ-DI Score >=0.35 at Baseline Week 12	27.3 percentage of participants	45.5 percentage of participants	51.8 percentage of participants
Percentage of Participants Who Achieved a Clinically Meaningful Improvement (>=0.35 Improvement From Baseline) in HAQ-DI Score by Visit Over Time Through Week 24 Among Participants With HAQ-DI Score >=0.35 at Baseline Week 4	20.0 percentage of participants	26.8 percentage of participants	30.9 percentage of participants
Percentage of Participants Who Achieved a Clinically Meaningful Improvement (>=0.35 Improvement From Baseline) in HAQ-DI Score by Visit Over Time Through Week 24 Among Participants With HAQ-DI Score >=0.35 at Baseline Week 16	30.9 percentage of participants	46.4 percentage of participants	57.3 percentage of participants
Percentage of Participants Who Achieved a Clinically Meaningful Improvement (>=0.35 Improvement From Baseline) in HAQ-DI Score by Visit Over Time Through Week 24 Among Participants With HAQ-DI Score >=0.35 at Baseline Week 20	28.2 percentage of participants	50.9 percentage of participants	56.4 percentage of participants
Percentage of Participants Who Achieved a Clinically Meaningful Improvement (>=0.35 Improvement From Baseline) in HAQ-DI Score by Visit Over Time Through Week 24 Among Participants With HAQ-DI Score >=0.35 at Baseline Week 24	29.1 percentage of participants	50.9 percentage of participants	57.3 percentage of participants

SECONDARY outcome

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

Population: Analysis population is FAS1. Participants who achieved DAS28 (CRP) response at a specific timepoint 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. DAS28 (CRP) response criteria was defined as follows: Good response: less than or equal to (\<=) 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

Outcome measures
Measure	Placebo 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=127 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=128 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Percentage of Participants Who Achieved a DAS28 (CRP) Response by Visit Over Time Through Week 24 Week 20	46.0 percentage of participants	66.1 percentage of participants	75.0 percentage of participants
Percentage of Participants Who Achieved a DAS28 (CRP) Response by Visit Over Time Through Week 24 Week 24	44.4 percentage of participants	70.9 percentage of participants	76.6 percentage of participants
Percentage of Participants Who Achieved a DAS28 (CRP) Response by Visit Over Time Through Week 24 Week 4	27.0 percentage of participants	33.1 percentage of participants	40.6 percentage of participants
Percentage of Participants Who Achieved a DAS28 (CRP) Response by Visit Over Time Through Week 24 Week 8	35.7 percentage of participants	59.1 percentage of participants	54.7 percentage of participants
Percentage of Participants Who Achieved a DAS28 (CRP) Response by Visit Over Time Through Week 24 Week 12	41.3 percentage of participants	67.7 percentage of participants	74.2 percentage of participants
Percentage of Participants Who Achieved a DAS28 (CRP) Response by Visit Over Time Through Week 24 Week 16	44.4 percentage of participants	65.4 percentage of participants	73.4 percentage of participants

SECONDARY outcome

Timeframe: Week 4, 8, 12, 16, 20 and 24

Population: Analysis population is FAS1. Participants who achieved DAS28 (CRP) remission at a specific timepoint 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

Outcome measures
Measure	Placebo 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=127 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=128 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Percentage of Participants Who Achieved a DAS28 (CRP) Remission by Visit Over Time Through Week 24 Week 4	3.2 percentage of participants	7.9 percentage of participants	7.8 percentage of participants
Percentage of Participants Who Achieved a DAS28 (CRP) Remission by Visit Over Time Through Week 24 Week 8	7.9 percentage of participants	11.0 percentage of participants	11.7 percentage of participants
Percentage of Participants Who Achieved a DAS28 (CRP) Remission by Visit Over Time Through Week 24 Week 12	9.5 percentage of participants	22.0 percentage of participants	21.9 percentage of participants
Percentage of Participants Who Achieved a DAS28 (CRP) Remission by Visit Over Time Through Week 24 Week 16	7.9 percentage of participants	19.7 percentage of participants	25.0 percentage of participants
Percentage of Participants Who Achieved a DAS28 (CRP) Remission by Visit Over Time Through Week 24 Week 20	17.5 percentage of participants	25.2 percentage of participants	36.7 percentage of participants
Percentage of Participants Who Achieved a DAS28 (CRP) Remission by Visit Over Time Through Week 24 Week 24	12.7 percentage of participants	23.6 percentage of participants	35.9 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 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 MAR and imputed using 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 change from baseline indicates improvement of arthritis.

Outcome measures

Outcome measures
Measure	Placebo 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=127 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=128 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Change From Baseline in DAS28 (CRP) Score at Weeks 4, 8, 12, 16, 20 and 24 Week 4	-0.35 units on a scale Interval -0.48 to -0.22	-0.53 units on a scale Interval -0.67 to -0.4	-0.56 units on a scale Interval -0.69 to -0.43
Change From Baseline in DAS28 (CRP) Score at Weeks 4, 8, 12, 16, 20 and 24 Week 8	-0.55 units on a scale Interval -0.71 to -0.39	-0.83 units on a scale Interval -0.99 to -0.67	-0.88 units on a scale Interval -1.04 to -0.72
Change From Baseline in DAS28 (CRP) Score at Weeks 4, 8, 12, 16, 20 and 24 Week 12	-0.63 units on a scale Interval -0.8 to -0.47	-1.16 units on a scale Interval -1.33 to -0.99	-1.23 units on a scale Interval -1.39 to -1.06
Change From Baseline in DAS28 (CRP) Score at Weeks 4, 8, 12, 16, 20 and 24 Week 16	-0.64 units on a scale Interval -0.82 to -0.46	-1.19 units on a scale Interval -1.37 to -1.01	-1.38 units on a scale Interval -1.56 to -1.2
Change From Baseline in DAS28 (CRP) Score at Weeks 4, 8, 12, 16, 20 and 24 Week 20	-0.80 units on a scale Interval -1.0 to -0.6	-1.38 units on a scale Interval -1.58 to -1.19	-1.56 units on a scale Interval -1.76 to -1.37
Change From Baseline in DAS28 (CRP) Score at Weeks 4, 8, 12, 16, 20 and 24 Week 24	-0.70 units on a scale Interval -0.89 to -0.51	-1.43 units on a scale Interval -1.61 to -1.24	-1.61 units on a scale Interval -1.8 to -1.42

SECONDARY outcome

Timeframe: Weeks 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) using 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

Outcome measures
Measure	Placebo 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=127 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=128 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) by Visit Over Time Through Week 24 Week 4	20.6 percentage of participants	29.1 percentage of participants	33.6 percentage of participants
Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) by Visit Over Time Through Week 24 Week 8	32.5 percentage of participants	56.7 percentage of participants	48.4 percentage of participants
Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) by Visit Over Time Through Week 24 Week 12	41.3 percentage of participants	58.3 percentage of participants	66.4 percentage of participants
Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) by Visit Over Time Through Week 24 Week 16	36.5 percentage of participants	64.6 percentage of participants	68.0 percentage of participants
Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) by Visit Over Time Through Week 24 Week 20	41.3 percentage of participants	66.1 percentage of participants	75.8 percentage of participants
Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) by Visit Over Time Through Week 24 Week 24	31.0 percentage of participants	59.8 percentage of participants	72.7 percentage of participants

SECONDARY outcome

Timeframe: Weeks 4, 8, 16, and 24

Population: FAS1 among the participants with enthesitis at baseline. Participants who achieved enthesitis resolution at a specific timepoint 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

Outcome measures
Measure	Placebo n=77 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=72 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=73 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Percentage of Participants Who Achieved Resolution of Enthesitis at Weeks 4, 8, 16, and 24 Among the Participants With Enthesitis at Baseline Week 8	23.4 percentage of participants	30.6 percentage of participants	30.1 percentage of participants
Percentage of Participants Who Achieved Resolution of Enthesitis at Weeks 4, 8, 16, and 24 Among the Participants With Enthesitis at Baseline Week 4	22.1 percentage of participants	18.1 percentage of participants	27.4 percentage of participants
Percentage of Participants Who Achieved Resolution of Enthesitis at Weeks 4, 8, 16, and 24 Among the Participants With Enthesitis at Baseline Week 16	37.7 percentage of participants	34.7 percentage of participants	45.2 percentage of participants
Percentage of Participants Who Achieved Resolution of Enthesitis at Weeks 4, 8, 16, and 24 Among the Participants With Enthesitis at Baseline Week 24	27.3 percentage of participants	40.3 percentage of participants	47.9 percentage of participants

SECONDARY outcome

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

Population: Analysis population is FAS1 among the participants with enthesitis at baseline. Data after meeting one or more TF criteria were imputed as no change from baseline. Missing data were assumed to be MAR and imputed using MI.

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

Outcome measures
Measure	Placebo n=77 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=72 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=73 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Change From Baseline in Enthesitis Score at Weeks 4, 8, 16 and 24 Among the Participants With Enthesitis at Baseline Week 4	-0.37 units on a scale Interval -0.69 to -0.05	-0.45 units on a scale Interval -0.78 to -0.11	-0.96 units on a scale Interval -1.3 to -0.62
Change From Baseline in Enthesitis Score at Weeks 4, 8, 16 and 24 Among the Participants With Enthesitis at Baseline Week 8	-0.65 units on a scale Interval -1.0 to -0.31	-0.83 units on a scale Interval -1.19 to -0.47	-1.11 units on a scale Interval -1.48 to -0.74
Change From Baseline in Enthesitis Score at Weeks 4, 8, 16 and 24 Among the Participants With Enthesitis at Baseline Week 16	-0.99 units on a scale Interval -1.36 to -0.61	-1.00 units on a scale Interval -1.39 to -0.61	-1.51 units on a scale Interval -1.9 to -1.11
Change From Baseline in Enthesitis Score at Weeks 4, 8, 16 and 24 Among the Participants With Enthesitis at Baseline Week 24	-1.01 units on a scale Interval -1.37 to -0.66	-1.35 units on a scale Interval -1.72 to -0.98	-1.75 units on a scale Interval -2.13 to -1.38

SECONDARY outcome

Timeframe: Weeks 4, 8, 16 and 24

Population: FAS1 among the participants with dactylitis at baseline. Participants who achieved dactylitis resolution at a specific timepoint 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

Outcome measures
Measure	Placebo n=55 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=49 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=38 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Percentage of Participants With Resolution of Dactylitis by Visit Over Time Through Week 24 Among the Participants With Dactylitis at Baseline Week 4	41.8 percentage of participants	34.7 percentage of participants	31.6 percentage of participants
Percentage of Participants With Resolution of Dactylitis by Visit Over Time Through Week 24 Among the Participants With Dactylitis at Baseline Week 8	41.8 percentage of participants	40.8 percentage of participants	44.7 percentage of participants
Percentage of Participants With Resolution of Dactylitis by Visit Over Time Through Week 24 Among the Participants With Dactylitis at Baseline Week 16	43.6 percentage of participants	59.2 percentage of participants	57.9 percentage of participants
Percentage of Participants With Resolution of Dactylitis by Visit Over Time Through Week 24 Among the Participants With Dactylitis at Baseline Week 24	49.1 percentage of participants	65.3 percentage of participants	63.2 percentage of participants

SECONDARY outcome

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

Population: Analysis population is FAS1 among the participants with dactylitis at baseline. Data after meeting one or more TF criteria were imputed as no change from baseline. Missing data were assumed to be MAR and imputed using MI.

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

Outcome measures
Measure	Placebo n=55 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=49 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=38 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Change From Baseline in Dactylitis Score at Weeks 4, 8, 16 and 24 Among the Participants With Dactylitis at Baseline Week 4	-2.77 units on a scale Interval -4.24 to -1.3	-2.24 units on a scale Interval -3.76 to -0.72	-2.63 units on a scale Interval -4.39 to -0.86
Change From Baseline in Dactylitis Score at Weeks 4, 8, 16 and 24 Among the Participants With Dactylitis at Baseline Week 8	-2.92 units on a scale Interval -4.58 to -1.26	-4.00 units on a scale Interval -5.72 to -2.29	-3.92 units on a scale Interval -5.9 to -1.93
Change From Baseline in Dactylitis Score at Weeks 4, 8, 16 and 24 Among the Participants With Dactylitis at Baseline Week 16	-4.03 units on a scale Interval -5.76 to -2.3	-6.00 units on a scale Interval -7.79 to -4.22	-6.29 units on a scale Interval -8.36 to -4.22
Change From Baseline in Dactylitis Score at Weeks 4, 8, 16 and 24 Among the Participants With Dactylitis at Baseline Week 24	-4.30 units on a scale Interval -5.96 to -2.63	-6.11 units on a scale Interval -7.81 to -4.41	-5.82 units on a scale Interval -7.82 to -3.83

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 MAR. 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 compositive 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 (0-6), tender dactylitis count (scoring each digit from 0-3 and recoding to 0-1, where any score \> 0 equaled 1), and the PCS score 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

Outcome measures
Measure	Placebo 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=127 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=128 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Change From Baseline in the Psoriatic Arthritis Disease Activity (PASDAS) Score at Weeks 8, 16 and 24 Week 8	-0.759 units on a scale Interval -0.961 to -0.556	-1.315 units on a scale Interval -1.518 to -1.113	-1.428 units on a scale Interval -1.628 to -1.228
Change From Baseline in the Psoriatic Arthritis Disease Activity (PASDAS) Score at Weeks 8, 16 and 24 Week 16	-0.980 units on a scale Interval -1.221 to -0.739	-1.779 units on a scale Interval -2.019 to -1.539	-2.083 units on a scale Interval -2.322 to -1.843
Change From Baseline in the Psoriatic Arthritis Disease Activity (PASDAS) Score at Weeks 8, 16 and 24 Week 24	-0.959 units on a scale Interval -1.212 to -0.707	-2.124 units on a scale Interval -2.376 to -1.871	-2.407 units on a scale Interval -2.657 to -2.156

SECONDARY outcome

Timeframe: Baseline, Weeks 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. LS mean is based on MMRM model that included data from all visits for all participants included in model. Here, n (number analyzed) signifies 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

Outcome measures
Measure	Placebo 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=127 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=128 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Change From Baseline in Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score at Weeks 16 and 24 Week 16	-0.918 units on a scale Interval -1.176 to -0.659	-2.024 units on a scale Interval -2.283 to -1.765	-2.368 units on a scale Interval -2.625 to -2.111
Change From Baseline in Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score at Weeks 16 and 24 Week 24	-0.854 units on a scale Interval -1.122 to -0.586	-2.368 units on a scale Interval -2.636 to -2.099	-2.735 units on a scale Interval -3.001 to -2.468

SECONDARY outcome

Timeframe: Baseline, Weeks 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 MAR. 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 psoriatic arthritis (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 (0-10 centimeter \[cm\] 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. 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

Outcome measures
Measure	Placebo 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=127 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=128 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Change From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 4, 8, 12, 16, 20 and 24 Week 8	-8.776 units on a scale Interval -11.307 to -6.246	-13.601 units on a scale Interval -16.118 to -11.084	-13.231 units on a scale Interval -15.731 to -10.732
Change From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 4, 8, 12, 16, 20 and 24 Week 16	-9.964 units on a scale Interval -12.568 to -7.359	-19.830 units on a scale Interval -22.426 to -17.234	-19.389 units on a scale Interval -21.977 to -16.802
Change From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 4, 8, 12, 16, 20 and 24 Week 24	-10.749 units on a scale Interval -13.396 to -8.102	-21.332 units on a scale Interval -23.977 to -18.688	-20.621 units on a scale Interval -23.251 to -17.992
Change From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 4, 8, 12, 16, 20 and 24 Week 4	-4.826 units on a scale Interval -6.901 to -2.752	-7.815 units on a scale Interval -9.926 to -5.705	-8.574 units on a scale Interval -10.636 to -6.511
Change From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 4, 8, 12, 16, 20 and 24 Week 12	-10.135 units on a scale Interval -12.67 to -7.599	-18.167 units on a scale Interval -20.704 to -15.631	-17.433 units on a scale Interval -19.949 to -14.918
Change From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 4, 8, 12, 16, 20 and 24 Week 20	-11.552 units on a scale Interval -14.228 to -8.876	-20.570 units on a scale Interval -23.248 to -17.891	-21.244 units on a scale Interval -23.903 to -18.586

SECONDARY outcome

Timeframe: Weeks 16 and Week 24

Population: Analysis population is FAS1. Participants who achieved MDA at a specific timepoint 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 was considered achieved if at least 5 of the following 7 criteria were met at the analysis visit: tender joint count \<=1; swollen joint count \<=1; psoriasis activity and severity index \<=1; patient's assessment of pain VAS score of \<=15; patient's global assessment of disease activity VAS (arthritis and psoriasis) score of \<=20; HAQ-DI \<=0.5; and tender entheseal points \<=1.

Outcome measures

Outcome measures
Measure	Placebo 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=127 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=128 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 16 and 24 Week 16	7.1 percentage of participants	15.7 percentage of participants	18.0 percentage of participants
Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 16 and 24 Week 24	11.1 percentage of participants	22.8 percentage of participants	30.5 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 with peripheral arthritis as their primary arthritic presentation of PsA completed the BASDAI indicate the degree of their symptoms over the past week.

Outcome measures

Outcome measures
Measure	Placebo n=23 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=24 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=20 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
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	26.1 percentage of participants	58.3 percentage of participants	55.0 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 >=20% Improvement	52.2 percentage of participants	75.0 percentage of participants	65.0 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 24: Participants with >=20% Improvement	26.1 percentage of participants	70.8 percentage of participants	65.0 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 8: Participants with >=50% Improvement	4.3 percentage of participants	25.0 percentage of participants	25.0 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 >=50% Improvement	26.1 percentage of participants	29.2 percentage of participants	35.0 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 24: Participants with >=50% Improvement	13.0 percentage of participants	41.7 percentage of participants	35.0 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 8: Participants with >=70% Improvement	4.3 percentage of participants	4.2 percentage of participants	15.0 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 >=70% Improvement	8.7 percentage of participants	25.0 percentage of participants	15.0 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 24: Participants with >=70% Improvement	8.7 percentage of participants	29.2 percentage of participants	5.0 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 8: Participants with >=90% Improvement	0 percentage of participants	0 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	0 percentage of participants	8.3 percentage of participants	10.0 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 24: Participants with >=90% Improvement	0 percentage of participants	16.7 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 8, 16, and 24

Population: Analysis population is FAS1 among the participants with spondylitis and peripheral arthritis 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.

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 with peripheral arthritis as their primary arthritic presentation of PsA completed the BASDAI indicate the degree of their symptoms over the past week.

Outcome measures

Outcome measures
Measure	Placebo n=23 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=24 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=20 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Change From Baseline in BASDAI Score at Week 8, 16, and Week 24 Among Participants With Spondylitis and Peripheral Arthritis at Baseline Week 8	-0.595 units on a scale Interval -1.351 to -0.162	-1.577 units on a scale Interval -2.296 to -0.859	-1.976 units on a scale Interval -2.779 to -1.174
Change From Baseline in BASDAI Score at Week 8, 16, and Week 24 Among Participants With Spondylitis and Peripheral Arthritis at Baseline Week 16	-1.604 units on a scale Interval -2.483 to -0.725	-2.419 units on a scale Interval -3.261 to -1.577	-2.469 units on a scale Interval -3.405 to -1.533
Change From Baseline in BASDAI Score at Week 8, 16, and Week 24 Among Participants With Spondylitis and Peripheral Arthritis at Baseline Week 24	-0.919 units on a scale Interval -1.795 to -0.043	-2.665 units on a scale Interval -3.503 to -1.826	-2.074 units on a scale Interval -3.006 to -1.142

SECONDARY outcome

Timeframe: Weeks 8, 16 and 24

Population: Analysis population is FAS1. Participants with low or very low disease activity at a specific timepoint 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.

PASDAS (score range of 0 to 10, where higher score indicated more severe disease) is a compositive 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 (0-6), tender dactylitis count (scoring each digit from 0-3 and recoding to 0-1, where any score \> 0 equaled 1), and the PCS score of the SF-36 health survey. The cutoffs for disease activity were 3.2 (low) to 5.4 (high).

Outcome measures

Outcome measures
Measure	Placebo 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=127 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=128 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Percentage of Participants With Low or Very Low Disease Activity Based on Psoriatic Arthritis Disease Activity Score (PASDAS) by Visit Over Time Through Week 24 Week 8	4.0 percentage of participants	10.2 percentage of participants	14.8 percentage of participants
Percentage of Participants With Low or Very Low Disease Activity Based on Psoriatic Arthritis Disease Activity Score (PASDAS) by Visit Over Time Through Week 24 Week 16	8.7 percentage of participants	22.0 percentage of participants	27.3 percentage of participants
Percentage of Participants With Low or Very Low Disease Activity Based on Psoriatic Arthritis Disease Activity Score (PASDAS) by Visit Over Time Through Week 24 Week 24	11.1 percentage of participants	30.7 percentage of participants	36.7 percentage of participants

SECONDARY outcome

Timeframe: Weeks 16 and 24

Population: Analysis population is FAS1. Participants with low disease activity at a specific timepoint 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.

GRACE index is a composite PsA disease activity score converted from Arithmetic Mean of the Desirability Function (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.

Outcome measures

Outcome measures
Measure	Placebo 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=127 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=128 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Percentage of Participants With Low Disease Activity Based on Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score Index by Visit Over Time Through Week 24 Week 16	10.3 percentage of participants	22.0 percentage of participants	28.9 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 by Visit Over Time Through Week 24 Week 24	11.9 percentage of participants	30.7 percentage of participants	42.2 percentage of participants

SECONDARY outcome

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

Population: Analysis population is FAS1. Participants with low disease activity or remission at a specific timepoint 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.

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.

Outcome measures

Outcome measures
Measure	Placebo 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=127 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=128 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Percentage of Participants With Low Disease Activity or Remission Based on Disease Activity Index for Psoriatic Arthritis (DAPSA) by Visit Over Time Through Week 24 Baseline	1.6 percentage of participants	2.4 percentage of participants	0.8 percentage of participants
Percentage of Participants With Low Disease Activity or Remission Based on Disease Activity Index for Psoriatic Arthritis (DAPSA) by Visit Over Time Through Week 24 Week 4	10.3 percentage of participants	8.7 percentage of participants	13.3 percentage of participants
Percentage of Participants With Low Disease Activity or Remission Based on Disease Activity Index for Psoriatic Arthritis (DAPSA) by Visit Over Time Through Week 24 Week 8	13.5 percentage of participants	17.3 percentage of participants	25.0 percentage of participants
Percentage of Participants With Low Disease Activity or Remission Based on Disease Activity Index for Psoriatic Arthritis (DAPSA) by Visit Over Time Through Week 24 Week 12	18.3 percentage of participants	27.6 percentage of participants	37.5 percentage of participants
Percentage of Participants With Low Disease Activity or Remission Based on Disease Activity Index for Psoriatic Arthritis (DAPSA) by Visit Over Time Through Week 24 Week 16	13.5 percentage of participants	29.9 percentage of participants	36.7 percentage of participants
Percentage of Participants With Low Disease Activity or Remission Based on Disease Activity Index for Psoriatic Arthritis (DAPSA) by Visit Over Time Through Week 24 Week 20	22.2 percentage of participants	37.8 percentage of participants	46.1 percentage of participants
Percentage of Participants With Low Disease Activity or Remission Based on Disease Activity Index for Psoriatic Arthritis (DAPSA) by Visit Over Time Through Week 24 Week 24	16.7 percentage of participants	40.9 percentage of participants	49.2 percentage of participants

SECONDARY outcome

Timeframe: Weeks 16 and 24

Population: Analysis population is FAS1. Participants who achieved VLDA response at a specific timepoint 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.

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

Outcome measures
Measure	Placebo 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=127 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=128 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Percentage of Participants With Very Low Disease Activity (VLDA) by Visit Over Time Through Week 24 Week 16	2.4 percentage of participants	3.1 percentage of participants	3.1 percentage of participants
Percentage of Participants With Very Low Disease Activity (VLDA) by Visit Over Time Through Week 24 Week 24	1.6 percentage of participants	3.9 percentage of participants	9.4 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

Outcome measures
Measure	Placebo 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=82 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=89 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Percentage of Participants Who Achieved PASI 75 Response at Weeks 16 and 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline Week 16	20.5 percentage of participants	63.4 percentage of participants	73.0 percentage of participants
Percentage of Participants Who Achieved PASI 75 Response at Weeks 16 and 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline Week 24	14.1 percentage of participants	75.6 percentage of participants	86.5 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

Outcome measures
Measure	Placebo 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=82 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=89 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Percentage of Participants Who Achieved PASI 90 Response at Weeks 16 and 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline Week 16	10.3 percentage of participants	45.1 percentage of participants	52.8 percentage of participants
Percentage of Participants Who Achieved PASI 90 Response at Weeks 16 and 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline Week 24	11.5 percentage of participants	50.0 percentage of participants	62.9 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

Outcome measures
Measure	Placebo 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=82 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=89 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Percentage of Participants Who Achieved PASI 100 Response by Visit Over Time Through Week 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline Week 16	7.7 percentage of participants	23.2 percentage of participants	32.6 percentage of participants
Percentage of Participants Who Achieved PASI 100 Response by Visit Over Time Through Week 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline Week 24	6.4 percentage of participants	25.6 percentage of participants	44.9 percentage of participants

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

Outcome measures
Measure	Placebo 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=82 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=89 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Percentage of Participants Who Achieved Both PASI 75 and ACR 20 Responses at Weeks 16 and 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 16	6.4 percentage of participants	35.4 percentage of participants	48.3 percentage of participants
Percentage of Participants Who Achieved Both PASI 75 and ACR 20 Responses at Weeks 16 and 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 24	6.4 percentage of participants	40.2 percentage of participants	52.8 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

Outcome measures
Measure	Placebo 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=82 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=89 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Percentage of Participants Who Achieved Both PASI 75 and Modified PsARC Response by Visit Over Time Through Week 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 16	9.0 percentage of participants	48.8 percentage of participants	55.1 percentage of participants
Percentage of Participants Who Achieved Both PASI 75 and Modified PsARC Response by Visit Over Time Through Week 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 24	5.1 percentage of participants	50.0 percentage of participants	62.9 percentage of participants

SECONDARY outcome

Timeframe: Weeks 16 and 24

Population: Analysis population is FAS1 among participants with \>=3% BSA psoriatic involvement and an IGA score of \>=2 at baseline.

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). Participants who achieved IGA Score of 0 (cleared) at a specific timepoint 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.

Outcome measures

Outcome measures
Measure	Placebo 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=82 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=89 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Percentage of Participants With an IGA Score of 0 (Cleared) at Weeks 16 and 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline Week 16	9.0 percentage of participants	32.9 percentage of participants	40.4 percentage of participants
Percentage of Participants With an IGA Score of 0 (Cleared) at Weeks 16 and 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	37.8 percentage of participants	53.9 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 16 and 24

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

Outcome measures
Measure	Placebo 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=82 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=89 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
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	-2.910 units on a scale Interval -4.207 to -1.612	-9.631 units on a scale Interval -10.881 to -8.381	-10.096 units on a scale Interval -11.318 to -8.874
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	-2.317 units on a scale Interval -3.709 to -0.926	-9.974 units on a scale Interval -11.323 to -8.624	-10.915 units on a scale Interval -12.224 to -9.605

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 MAR and imputed using 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

Outcome measures
Measure	Placebo 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=127 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=128 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) at Weeks 8, 16 and 24 Week 8	2.15 units on a scale Interval 1.06 to 3.23	2.87 units on a scale Interval 1.8 to 3.95	4.46 units on a scale Interval 3.39 to 5.54
Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) at Weeks 8, 16 and 24 Week 16	2.50 units on a scale Interval 1.31 to 3.69	5.26 units on a scale Interval 4.08 to 6.43	6.72 units on a scale Interval 5.54 to 7.89
Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) at Weeks 8, 16 and 24 Week 24	1.96 units on a scale Interval 0.69 to 3.24	6.10 units on a scale Interval 4.83 to 7.37	6.87 units on a scale Interval 5.6 to 8.14

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 MAR and imputed using 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

Outcome measures
Measure	Placebo 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=127 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=128 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Change From Baseline in 36-Item Short Form Health Survey (SF-36) Mental Component Summary (MCS) at Weeks 8, 16 and 24 Week 8	1.99 units on a scale Interval 0.73 to 3.24	2.72 units on a scale Interval 1.47 to 3.97	2.46 units on a scale Interval 1.22 to 3.71
Change From Baseline in 36-Item Short Form Health Survey (SF-36) Mental Component Summary (MCS) at Weeks 8, 16 and 24 Week 16	2.25 units on a scale Interval 0.87 to 3.63	2.61 units on a scale Interval 1.25 to 3.98	3.04 units on a scale Interval 1.68 to 4.41
Change From Baseline in 36-Item Short Form Health Survey (SF-36) Mental Component Summary (MCS) at Weeks 8, 16 and 24 Week 24	2.37 units on a scale Interval 0.93 to 3.81	3.20 units on a scale Interval 1.78 to 4.63	3.60 units on a scale Interval 2.17 to 5.02

SECONDARY outcome

Timeframe: Baseline, Week 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

Outcome measures
Measure	Placebo 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=127 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=128 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 Week 8: Physical Function Score	1.362 units on a scale Interval 0.201 to 2.524	2.616 units on a scale Interval 1.456 to 3.777	4.082 units on a scale Interval 2.927 to 5.237
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 Week 16: Physical Function Score	1.901 units on a scale Interval 0.603 to 3.199	5.143 units on a scale Interval 3.851 to 6.434	6.190 units on a scale Interval 4.902 to 7.478
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 Week 24: Physical Function Score	1.636 units on a scale Interval 0.249 to 3.023	5.776 units on a scale Interval 4.394 to 7.158	6.952 units on a scale Interval 5.571 to 8.333
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 Week 8: Role-physical Score	2.212 units on a scale Interval 1.104 to 3.321	2.084 units on a scale Interval 0.978 to 3.19	3.834 units on a scale Interval 2.73 to 4.938
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 Week 16: Role-physical Score	2.242 units on a scale Interval 1.037 to 3.447	4.224 units on a scale Interval 3.027 to 5.422	5.447 units on a scale Interval 4.25 to 6.644
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 Week 24: Role-physical Score	2.319 units on a scale Interval 1.063 to 3.576	4.878 units on a scale Interval 3.627 to 6.13	5.442 units on a scale Interval 4.189 to 6.694
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 Week 8: Bodily Pain Score	3.081 units on a scale Interval 1.876 to 4.286	3.886 units on a scale Interval 2.682 to 5.089	5.140 units on a scale Interval 3.941 to 6.338
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 Week 16: Bodily Pain Score	3.125 units on a scale Interval 1.859 to 4.391	5.059 units on a scale Interval 3.8 to 6.318	6.778 units on a scale Interval 5.521 to 8.035
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 Week 24: Bodily Pain Score	2.854 units on a scale Interval 1.468 to 4.24	6.840 units on a scale Interval 5.459 to 8.221	7.490 units on a scale Interval 6.11 to 8.871
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 Week 8: General Health Score	1.989 units on a scale Interval 0.806 to 3.172	3.071 units on a scale Interval 1.89 to 4.252	3.486 units on a scale Interval 2.309 to 4.663
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 Week 16: General Health Score	1.683 units on a scale Interval 0.492 to 2.874	3.769 units on a scale Interval 2.585 to 4.953	5.225 units on a scale Interval 4.042 to 6.408
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 Week 24: General Health Score	1.690 units on a scale Interval 0.51 to 2.869	4.349 units on a scale Interval 3.175 to 5.524	5.174 units on a scale Interval 3.998 to 6.349
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 Week 8: Vitality Score	2.312 units on a scale Interval 1.081 to 3.542	3.917 units on a scale Interval 2.689 to 5.144	4.614 units on a scale Interval 3.389 to 5.838
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 Week 16: Vitality Score	3.084 units on a scale Interval 1.72 to 4.449	4.777 units on a scale Interval 3.422 to 6.133	5.589 units on a scale Interval 4.234 to 6.943
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 Week 24: Vitality Score	2.311 units on a scale Interval 0.881 to 3.742	5.596 units on a scale Interval 4.172 to 7.02	6.426 units on a scale Interval 5.0 to 7.852
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 Week 8: Social Function Score	2.025 units on a scale Interval 0.643 to 3.407	3.287 units on a scale Interval 1.907 to 4.667	3.798 units on a scale Interval 2.423 to 5.173
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 Week 16: Social Function Score	2.455 units on a scale Interval 1.02 to 3.89	3.531 units on a scale Interval 2.105 to 4.957	4.817 units on a scale Interval 3.392 to 6.241
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 Week 24: Social Function Score	2.582 units on a scale Interval 1.24 to 3.924	5.426 units on a scale Interval 4.089 to 6.762	5.227 units on a scale Interval 3.889 to 6.564
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 Week 8: Role-emotional Score	1.980 units on a scale Interval 0.615 to 3.345	2.237 units on a scale Interval 0.877 to 3.598	1.987 units on a scale Interval 0.631 to 3.343
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 Week 16: Role-emotional Score	1.784 units on a scale Interval 0.316 to 3.253	2.496 units on a scale Interval 1.04 to 3.953	3.265 units on a scale Interval 1.81 to 4.72
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 Week 24: Role-emotional Score	2.201 units on a scale Interval 0.753 to 3.649	2.415 units on a scale Interval 0.976 to 3.853	3.531 units on a scale Interval 2.09 to 4.972
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 Week 8: Mental Health Score	2.124 units on a scale Interval 0.901 to 3.348	2.574 units on a scale Interval 1.358 to 3.79	3.126 units on a scale Interval 1.914 to 4.339
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 Week 16: Mental Health Score	2.360 units on a scale Interval 1.058 to 3.662	3.489 units on a scale Interval 2.2 to 4.777	3.984 units on a scale Interval 2.696 to 5.272
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 Week 24: Mental Health Score	2.062 units on a scale Interval 0.658 to 3.466	3.818 units on a scale Interval 2.425 to 5.211	4.356 units on a scale Interval 2.961 to 5.751

SECONDARY outcome

Timeframe: Weeks 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

Outcome measures
Measure	Placebo 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=127 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=128 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score by Visit Over Time Through Week 24 Week 8	27.0 percentage of participants	33.9 percentage of participants	35.2 percentage of participants
Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score by Visit Over Time Through Week 24 Week 16	31.0 percentage of participants	32.3 percentage of participants	39.8 percentage of participants
Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score by Visit Over Time Through Week 24 Week 24	25.4 percentage of participants	37.8 percentage of participants	43.0 percentage of participants

SECONDARY outcome

Timeframe: Weeks 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

Outcome measures
Measure	Placebo 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=127 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=128 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Percentage of Participants Who Achieved >=5 Point Improvement From Baseline in SF-36 PCS Score Through Week 24 Week 8	31.0 percentage of participants	33.9 percentage of participants	46.1 percentage of participants
Percentage of Participants Who Achieved >=5 Point Improvement From Baseline in SF-36 PCS Score Through Week 24 Week 16	29.4 percentage of participants	48.0 percentage of participants	50.0 percentage of participants
Percentage of Participants Who Achieved >=5 Point Improvement From Baseline in SF-36 PCS Score Through Week 24 Week 24	28.6 percentage of participants	51.2 percentage of participants	53.9 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 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

Outcome measures
Measure	Placebo 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=127 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=128 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 8, 16, and 24 Week 8	2.356 units on a scale Interval 1.081 to 3.632	3.643 units on a scale Interval 2.369 to 4.917	3.576 units on a scale Interval 2.306 to 4.845
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 8, 16, and 24 Week 16	2.164 units on a scale Interval 0.782 to 3.547	4.853 units on a scale Interval 3.478 to 6.228	4.544 units on a scale Interval 3.171 to 5.918
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 8, 16, and 24 Week 24	2.206 units on a scale Interval 0.773 to 3.638	5.609 units on a scale Interval 4.181 to 7.036	5.841 units on a scale Interval 4.416 to 7.267

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

Outcome measures
Measure	Placebo 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=127 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=128 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score at Weeks 8, 16, and 24 Week 8	35.7 percentage of participants	44.1 percentage of participants	43.8 percentage of participants
Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score at Weeks 8, 16, and 24 Week 16	34.1 percentage of participants	50.4 percentage of participants	52.3 percentage of participants
Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score at Weeks 8, 16, and 24 Week 24	34.9 percentage of participants	53.5 percentage of participants	63.3 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 MAR. The LS mean is based on MMRM model that included data from all visits for all participants included in the model.

PROMIS-29 contains 4 items for each of seven PROMIS domains (Anxiety, Depression, Fatigue, Pain Interference, Physical Function, Sleep Disturbance, and Satisfaction-Social Role and Activity. PROMIS-29 also includes an additional pain intensity 0-10 numeric rating scale (NRS). The raw score of each domain is converted into a standardized score with a mean of 50 and a standard deviation (SD) of 10 for the general population in the US (T-Score).

Outcome measures

Outcome measures
Measure	Placebo 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=127 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=128 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Scores at Weeks 8, 16 and 24 Week 16: Sleep Disturbance	-1.54 T-score Interval -2.53 to -0.54	-3.82 T-score Interval -4.82 to -2.83	-3.09 T-score Interval -4.08 to -2.1
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Scores at Weeks 8, 16 and 24 Week 16: Physical Function	1.53 T-score Interval 0.49 to 2.57	3.21 T-score Interval 2.17 to 4.24	4.12 T-score Interval 3.09 to 5.15
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Scores at Weeks 8, 16 and 24 Week 24: Physical Function	1.34 T-score Interval 0.25 to 2.43	3.89 T-score Interval 2.81 to 4.98	5.05 T-score Interval 3.96 to 6.13
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Scores at Weeks 8, 16 and 24 Week 8: Sleep Disturbance	-1.22 T-score Interval -2.23 to -0.21	-1.91 T-score Interval -2.92 to -0.91	-2.09 T-score Interval -3.09 to -1.09
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Scores at Weeks 8, 16 and 24 Week 24: Sleep Disturbance	-1.17 T-score Interval -2.25 to -0.09	-3.48 T-score Interval -4.56 to -2.4	-2.46 T-score Interval -3.53 to -1.38
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Scores at Weeks 8, 16 and 24 Week 8: Satisfaction-Social Role and Activity	1.52 T-score Interval 0.39 to 2.64	3.13 T-score Interval 2.01 to 4.25	3.18 T-score Interval 2.06 to 4.29
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Scores at Weeks 8, 16 and 24 Week 16: Satisfaction-Social Role and Activity	1.86 T-score Interval 0.65 to 3.08	3.93 T-score Interval 2.72 to 5.14	3.97 T-score Interval 2.76 to 5.17
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Scores at Weeks 8, 16 and 24 Week 24: Satisfaction-Social Role and Activity	1.45 T-score Interval 0.22 to 2.69	4.90 T-score Interval 3.66 to 6.13	4.52 T-score Interval 3.29 to 5.75
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Scores at Weeks 8, 16 and 24 Week 8: Pain Intensity	-0.74 T-score Interval -1.06 to -0.41	-1.34 T-score Interval -1.66 to -1.01	-1.28 T-score Interval -1.61 to -0.96
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Scores at Weeks 8, 16 and 24 Week 16: Pain Intensity	-0.73 T-score Interval -1.09 to -0.37	-1.63 T-score Interval -1.98 to -1.27	-2.03 T-score Interval -2.38 to -1.67
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Scores at Weeks 8, 16 and 24 Week 24: Pain Intensity	-0.56 T-score Interval -0.94 to -0.19	-1.98 T-score Interval -2.36 to -1.61	-2.32 T-score Interval -2.69 to -1.94
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Scores at Weeks 8, 16 and 24 Week 24: Fatigue	-1.86 T-score Interval -3.24 to -0.48	-4.79 T-score Interval -6.16 to -3.42	-5.08 T-score Interval -6.45 to -3.71
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Scores at Weeks 8, 16 and 24 Week 8: Pain Interference	-2.42 T-score Interval -3.4 to -1.43	-2.99 T-score Interval -3.97 to -2.0	-3.32 T-score Interval -4.3 to -2.33
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Scores at Weeks 8, 16 and 24 Week 16: Pain Interference	-2.62 T-score Interval -3.69 to -1.55	-3.99 T-score Interval -5.06 to -2.93	-5.02 T-score Interval -6.08 to -3.96
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Scores at Weeks 8, 16 and 24 Week 24: Pain Interference	-2.30 T-score Interval -3.46 to -1.13	-5.49 T-score Interval -6.65 to -4.34	-5.69 T-score Interval -6.85 to -4.53
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Scores at Weeks 8, 16 and 24 Week 8: Physical Function	1.34 T-score Interval 0.44 to 2.23	1.31 T-score Interval 0.42 to 2.2	2.37 T-score Interval 1.48 to 3.26
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Scores at Weeks 8, 16 and 24 Week 8: Anxiety	-1.98 T-score Interval -3.29 to -0.66	-2.19 T-score Interval -3.5 to -0.88	-1.83 T-score Interval -3.14 to -0.53
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Scores at Weeks 8, 16 and 24 Week 16: Anxiety	-2.30 T-score Interval -3.63 to -0.97	-3.08 T-score Interval -4.4 to -1.75	-2.23 T-score Interval -3.54 to -0.91
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Scores at Weeks 8, 16 and 24 Week 24: Anxiety	-1.37 T-score Interval -2.71 to -0.03	-3.23 T-score Interval -4.57 to -1.89	-2.92 T-score Interval -4.25 to -1.59
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Scores at Weeks 8, 16 and 24 Week 8: Depression	-0.86 T-score Interval -2.07 to 0.35	-2.42 T-score Interval -3.63 to -1.21	-1.54 T-score Interval -2.74 to -0.34
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Scores at Weeks 8, 16 and 24 Week 16: Depression	-0.85 T-score Interval -2.02 to 0.31	-2.70 T-score Interval -3.87 to -1.54	-2.69 T-score Interval -3.85 to -1.54
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Scores at Weeks 8, 16 and 24 Week 24: Depression	-0.85 T-score Interval -2.12 to 0.42	-3.40 T-score Interval -4.66 to -2.14	-2.67 T-score Interval -3.92 to -1.41
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Scores at Weeks 8, 16 and 24 Week 8: Fatigue	-1.87 T-score Interval -3.13 to -0.62	-3.25 T-score Interval -4.5 to -1.99	-2.90 T-score Interval -4.14 to -1.65
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Scores at Weeks 8, 16 and 24 Week 16: Fatigue	-2.29 T-score Interval -3.57 to -1.02	-4.26 T-score Interval -5.53 to -2.99	-4.14 T-score Interval -5.4 to -2.88

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. Here, n (number analyzed) signifies the number of participants who were ACR 20 responders or non-responders at Week 24.

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

Outcome measures
Measure	Placebo 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=127 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=128 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Change From Baseline in FACIT-Fatigue Score at Week 24 by ACR 20 Response at Week 24 Among ACR 20 responders	8.571 units on a scale Standard Deviation 7.8995	9.242 units on a scale Standard Deviation 10.8473	6.684 units on a scale Standard Deviation 8.0948
Change From Baseline in FACIT-Fatigue Score at Week 24 by ACR 20 Response at Week 24 Among ACR 20 non-responders	0.316 units on a scale Standard Deviation 6.8181	1.984 units on a scale Standard Deviation 7.8877	3.635 units on a scale Standard Deviation 6.8170

SECONDARY outcome

Timeframe: Week 24

Population: FAS1. Participants who achieved \>=4-point improvement from baseline at Week 24 and did not meet any TF criteria before Week 24: responders. Participants who met 1 or more TF criteria or with missing data: non-responders. Here, n (number analyzed) signifies the number of participants who were ACR 20 responders or non-responders at Week 24.

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

Outcome measures
Measure	Placebo 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=127 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=128 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score at Week 24 by ACR 20 Response at Week 24 Among ACR 20 responders	67.9 percentage of participants	68.2 percentage of participants	73.7 percentage of participants
Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score at Week 24 by ACR 20 Response at Week 24 Among ACR 20 non-responders	25.5 percentage of participants	37.7 percentage of participants	48.1 percentage of participants

SECONDARY outcome

Timeframe: Weeks 8, 16, and 24

Population: Analysis population is FAS1. Participants who achieved \>=3-point improvement from baseline in PROMIS-29 domain scores at a specific timepoint and did not meet any TF criteria before, considered as responders at that time point. Participants who met 1 or more TF criteria before or with missing data at that time point, considered as non-responders.

PROMIS-29 contains 4 items for each of seven PROMIS domains (Anxiety, Depression, Fatigue, Pain Interference, Physical Function, Sleep Disturbance, and Satisfaction-Social Role and Activity. PROMIS-29 also includes an additional pain intensity 0-10 NRS. The raw score of each domain is converted into a standardized score with a mean of 50 and a SD of 10 for the general population in the US (T-Score).

Outcome measures

Outcome measures
Measure	Placebo 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=127 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=128 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Percentage of Participants Who Achieved an Improvement of >=3 Points From Baseline in PROMIS-29 Domain Scores at Weeks 8, 16, and 24 Week 8: Pain Intensity	15.1 percentage of participants	22.8 percentage of participants	26.6 percentage of participants
Percentage of Participants Who Achieved an Improvement of >=3 Points From Baseline in PROMIS-29 Domain Scores at Weeks 8, 16, and 24 Week 8: Physical Function	28.6 percentage of participants	30.7 percentage of participants	40.6 percentage of participants
Percentage of Participants Who Achieved an Improvement of >=3 Points From Baseline in PROMIS-29 Domain Scores at Weeks 8, 16, and 24 Week 8: Anxiety	41.3 percentage of participants	41.7 percentage of participants	39.1 percentage of participants
Percentage of Participants Who Achieved an Improvement of >=3 Points From Baseline in PROMIS-29 Domain Scores at Weeks 8, 16, and 24 Week 16: Anxiety	-34.9 percentage of participants	42.5 percentage of participants	41.4 percentage of participants
Percentage of Participants Who Achieved an Improvement of >=3 Points From Baseline in PROMIS-29 Domain Scores at Weeks 8, 16, and 24 Week 24: Anxiety	34.9 percentage of participants	45.7 percentage of participants	42.2 percentage of participants
Percentage of Participants Who Achieved an Improvement of >=3 Points From Baseline in PROMIS-29 Domain Scores at Weeks 8, 16, and 24 Week 8: Depression	24.6 percentage of participants	30.7 percentage of participants	34.4 percentage of participants
Percentage of Participants Who Achieved an Improvement of >=3 Points From Baseline in PROMIS-29 Domain Scores at Weeks 8, 16, and 24 Week 16: Depression	25.4 percentage of participants	35.4 percentage of participants	33.6 percentage of participants
Percentage of Participants Who Achieved an Improvement of >=3 Points From Baseline in PROMIS-29 Domain Scores at Weeks 8, 16, and 24 Week 24: Depression	26.2 percentage of participants	39.4 percentage of participants	38.3 percentage of participants
Percentage of Participants Who Achieved an Improvement of >=3 Points From Baseline in PROMIS-29 Domain Scores at Weeks 8, 16, and 24 Week 8: Fatigue	34.1 percentage of participants	39.4 percentage of participants	42.2 percentage of participants
Percentage of Participants Who Achieved an Improvement of >=3 Points From Baseline in PROMIS-29 Domain Scores at Weeks 8, 16, and 24 Week 16: Fatigue	38.9 percentage of participants	49.6 percentage of participants	49.2 percentage of participants
Percentage of Participants Who Achieved an Improvement of >=3 Points From Baseline in PROMIS-29 Domain Scores at Weeks 8, 16, and 24 Week 24: Fatigue	32.5 percentage of participants	48.8 percentage of participants	55.5 percentage of participants
Percentage of Participants Who Achieved an Improvement of >=3 Points From Baseline in PROMIS-29 Domain Scores at Weeks 8, 16, and 24 Week 8: Pain Interference	34.9 percentage of participants	41.7 percentage of participants	43.8 percentage of participants
Percentage of Participants Who Achieved an Improvement of >=3 Points From Baseline in PROMIS-29 Domain Scores at Weeks 8, 16, and 24 Week 16: Pain Interference	39.7 percentage of participants	47.2 percentage of participants	56.3 percentage of participants
Percentage of Participants Who Achieved an Improvement of >=3 Points From Baseline in PROMIS-29 Domain Scores at Weeks 8, 16, and 24 Week 24: Pain Interference	33.3 percentage of participants	54.3 percentage of participants	57.0 percentage of participants
Percentage of Participants Who Achieved an Improvement of >=3 Points From Baseline in PROMIS-29 Domain Scores at Weeks 8, 16, and 24 Week 16: Physical Function	28.6 percentage of participants	44.1 percentage of participants	45.3 percentage of participants
Percentage of Participants Who Achieved an Improvement of >=3 Points From Baseline in PROMIS-29 Domain Scores at Weeks 8, 16, and 24 Week 24: Physical Function	22.2 percentage of participants	48.0 percentage of participants	53.9 percentage of participants
Percentage of Participants Who Achieved an Improvement of >=3 Points From Baseline in PROMIS-29 Domain Scores at Weeks 8, 16, and 24 Week 8: Sleep Disturbance	35.7 percentage of participants	38.6 percentage of participants	39.1 percentage of participants
Percentage of Participants Who Achieved an Improvement of >=3 Points From Baseline in PROMIS-29 Domain Scores at Weeks 8, 16, and 24 Week 16: Sleep Disturbance	36.5 percentage of participants	48.8 percentage of participants	38.3 percentage of participants
Percentage of Participants Who Achieved an Improvement of >=3 Points From Baseline in PROMIS-29 Domain Scores at Weeks 8, 16, and 24 Week 24: Sleep Disturbance	31.0 percentage of participants	48.8 percentage of participants	40.6 percentage of participants
Percentage of Participants Who Achieved an Improvement of >=3 Points From Baseline in PROMIS-29 Domain Scores at Weeks 8, 16, and 24 Week 8: Satisfaction-Social Role and Activity	35.7 percentage of participants	44.9 percentage of participants	49.2 percentage of participants
Percentage of Participants Who Achieved an Improvement of >=3 Points From Baseline in PROMIS-29 Domain Scores at Weeks 8, 16, and 24 Week 16: Satisfaction-Social Role and Activity	37.3 percentage of participants	46.5 percentage of participants	46.1 percentage of participants
Percentage of Participants Who Achieved an Improvement of >=3 Points From Baseline in PROMIS-29 Domain Scores at Weeks 8, 16, and 24 Week 24: Satisfaction-Social Role and Activity	32.5 percentage of participants	52.0 percentage of participants	50.0 percentage of participants
Percentage of Participants Who Achieved an Improvement of >=3 Points From Baseline in PROMIS-29 Domain Scores at Weeks 8, 16, and 24 Week 16: Pain Intensity	18.3 percentage of participants	33.1 percentage of participants	42.2 percentage of participants
Percentage of Participants Who Achieved an Improvement of >=3 Points From Baseline in PROMIS-29 Domain Scores at Weeks 8, 16, and 24 Week 24: Pain Intensity	15.1 percentage of participants	37.0 percentage of participants	45.3 percentage of participants

SECONDARY outcome

Timeframe: Weeks 8, 16, and 24

Population: Analysis population is FAS1. Participants who achieved \>=5-point improvement from baseline in PROMIS-29 domain scores at a specific timepoint and did not meet any TF criteria before, considered as responders at that time point. Participants who met 1 or more TF criteria before or with missing data at that time point, considered as non-responders.

PROMIS-29 contains 4 items for each of seven PROMIS domains (Anxiety, Depression, Fatigue, Pain Interference, Physical Function, Sleep Disturbance, and Satisfaction-Social Role and Activity. PROMIS-29 also includes an additional pain intensity 0-10 NRS. The raw score of each domain is converted into a standardized score with a mean of 50 and a SD of 10 for the general population in the US (T-Score).

Outcome measures

Outcome measures
Measure	Placebo 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=127 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=128 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Percentage of Participants Who Achieved an Improvement of >=5 Points From Baseline in PROMIS-29 Domain Scores at Weeks 8, 16, and 24 Week 8: Sleep Disturbance	24.6 percentage of participants	24.4 percentage of participants	27.3 percentage of participants
Percentage of Participants Who Achieved an Improvement of >=5 Points From Baseline in PROMIS-29 Domain Scores at Weeks 8, 16, and 24 Week 8: Anxiety	33.3 percentage of participants	37.0 percentage of participants	29.7 percentage of participants
Percentage of Participants Who Achieved an Improvement of >=5 Points From Baseline in PROMIS-29 Domain Scores at Weeks 8, 16, and 24 Week 16: Anxiety	29.4 percentage of participants	34.6 percentage of participants	33.6 percentage of participants
Percentage of Participants Who Achieved an Improvement of >=5 Points From Baseline in PROMIS-29 Domain Scores at Weeks 8, 16, and 24 Week 24: Anxiety	28.6 percentage of participants	41.7 percentage of participants	38.3 percentage of participants
Percentage of Participants Who Achieved an Improvement of >=5 Points From Baseline in PROMIS-29 Domain Scores at Weeks 8, 16, and 24 Week 8: Depression	17.5 percentage of participants	27.6 percentage of participants	26.6 percentage of participants
Percentage of Participants Who Achieved an Improvement of >=5 Points From Baseline in PROMIS-29 Domain Scores at Weeks 8, 16, and 24 Week 16: Depression	19.0 percentage of participants	32.3 percentage of participants	28.9 percentage of participants
Percentage of Participants Who Achieved an Improvement of >=5 Points From Baseline in PROMIS-29 Domain Scores at Weeks 8, 16, and 24 Week 24: Depression	19.8 percentage of participants	36.2 percentage of participants	30.5 percentage of participants
Percentage of Participants Who Achieved an Improvement of >=5 Points From Baseline in PROMIS-29 Domain Scores at Weeks 8, 16, and 24 Week 8: Fatigue	27.8 percentage of participants	29.1 percentage of participants	33.6 percentage of participants
Percentage of Participants Who Achieved an Improvement of >=5 Points From Baseline in PROMIS-29 Domain Scores at Weeks 8, 16, and 24 Week 16: Fatigue	33.3 percentage of participants	40.9 percentage of participants	43.0 percentage of participants
Percentage of Participants Who Achieved an Improvement of >=5 Points From Baseline in PROMIS-29 Domain Scores at Weeks 8, 16, and 24 Week 24: Fatigue	31.0 percentage of participants	45.7 percentage of participants	47.7 percentage of participants
Percentage of Participants Who Achieved an Improvement of >=5 Points From Baseline in PROMIS-29 Domain Scores at Weeks 8, 16, and 24 Week 8: Pain Interference	22.2 percentage of participants	29.9 percentage of participants	35.9 percentage of participants
Percentage of Participants Who Achieved an Improvement of >=5 Points From Baseline in PROMIS-29 Domain Scores at Weeks 8, 16, and 24 Week 16: Pain Interference	29.4 percentage of participants	38.6 percentage of participants	43.8 percentage of participants
Percentage of Participants Who Achieved an Improvement of >=5 Points From Baseline in PROMIS-29 Domain Scores at Weeks 8, 16, and 24 Week 24: Pain Interference	23.8 percentage of participants	46.5 percentage of participants	51.6 percentage of participants
Percentage of Participants Who Achieved an Improvement of >=5 Points From Baseline in PROMIS-29 Domain Scores at Weeks 8, 16, and 24 Week 16: Physical Function	18.3 percentage of participants	26.8 percentage of participants	32.8 percentage of participants
Percentage of Participants Who Achieved an Improvement of >=5 Points From Baseline in PROMIS-29 Domain Scores at Weeks 8, 16, and 24 Week 8: Physical Function	15.1 percentage of participants	18.9 percentage of participants	22.7 percentage of participants
Percentage of Participants Who Achieved an Improvement of >=5 Points From Baseline in PROMIS-29 Domain Scores at Weeks 8, 16, and 24 Week 24: Physical Function	15.9 percentage of participants	36.2 percentage of participants	39.8 percentage of participants
Percentage of Participants Who Achieved an Improvement of >=5 Points From Baseline in PROMIS-29 Domain Scores at Weeks 8, 16, and 24 Week 16: Sleep Disturbance	24.6 percentage of participants	40.2 percentage of participants	30.5 percentage of participants
Percentage of Participants Who Achieved an Improvement of >=5 Points From Baseline in PROMIS-29 Domain Scores at Weeks 8, 16, and 24 Week 24: Sleep Disturbance	21.4 percentage of participants	37.0 percentage of participants	32.8 percentage of participants
Percentage of Participants Who Achieved an Improvement of >=5 Points From Baseline in PROMIS-29 Domain Scores at Weeks 8, 16, and 24 Week 8: Satisfaction-Social Role and Activity	25.4 percentage of participants	40.2 percentage of participants	38.3 percentage of participants
Percentage of Participants Who Achieved an Improvement of >=5 Points From Baseline in PROMIS-29 Domain Scores at Weeks 8, 16, and 24 Week 16: Satisfaction-Social Role and Activity	30.2 percentage of participants	42.5 percentage of participants	39.8 percentage of participants
Percentage of Participants Who Achieved an Improvement of >=5 Points From Baseline in PROMIS-29 Domain Scores at Weeks 8, 16, and 24 Week 24: Satisfaction-Social Role and Activity	22.2 percentage of participants	45.7 percentage of participants	43.0 percentage of participants
Percentage of Participants Who Achieved an Improvement of >=5 Points From Baseline in PROMIS-29 Domain Scores at Weeks 8, 16, and 24 Week 8: Pain Intensity	5.6 percentage of participants	6.3 percentage of participants	6.3 percentage of participants
Percentage of Participants Who Achieved an Improvement of >=5 Points From Baseline in PROMIS-29 Domain Scores at Weeks 8, 16, and 24 Week 16: Pain Intensity	6.3 percentage of participants	8.7 percentage of participants	14.8 percentage of participants
Percentage of Participants Who Achieved an Improvement of >=5 Points From Baseline in PROMIS-29 Domain Scores at Weeks 8, 16, and 24 Week 24: Pain Intensity	4.0 percentage of participants	18.1 percentage of participants	18.0 percentage of participants

SECONDARY outcome

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

Population: Analysis population is 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

Outcome measures
Measure	Placebo n=114 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 48 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) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=125 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Percentage of Participants Who Achieved ACR 20 Response at Weeks 24, 28, 36, 44 and 52 Week 24	27.2 percentage of participants	54.5 percentage of participants	60.8 percentage of participants
Percentage of Participants Who Achieved ACR 20 Response at Weeks 24, 28, 36, 44 and 52 Week 28	50.0 percentage of participants	68.9 percentage of participants	74.4 percentage of participants
Percentage of Participants Who Achieved ACR 20 Response at Weeks 24, 28, 36, 44 and 52 Week 36	56.9 percentage of participants	70.3 percentage of participants	71.1 percentage of participants
Percentage of Participants Who Achieved ACR 20 Response at Weeks 24, 28, 36, 44 and 52 Week 44	61.7 percentage of participants	73.5 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 52	68.3 percentage of participants	67.9 percentage of participants	75.8 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

Outcome measures
Measure	Placebo n=114 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 48 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) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=125 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Percentage of Participants Who Achieved ACR 50 Response at Weeks 24, 28, 36, 44 and 52 Week 24	9.6 percentage of participants	30.9 percentage of participants	36.8 percentage of participants
Percentage of Participants Who Achieved ACR 50 Response at Weeks 24, 28, 36, 44 and 52 Week 28	21.4 percentage of participants	42.6 percentage of participants	39.2 percentage of participants
Percentage of Participants Who Achieved ACR 50 Response at Weeks 24, 28, 36, 44 and 52 Week 36	32.7 percentage of participants	47.1 percentage of participants	44.6 percentage of participants
Percentage of Participants Who Achieved ACR 50 Response at Weeks 24, 28, 36, 44 and 52 Week 44	30.8 percentage of participants	51.3 percentage of participants	46.0 percentage of participants
Percentage of Participants Who Achieved ACR 50 Response at Weeks 24, 28, 36, 44 and 52 Week 52	36.5 percentage of participants	43.4 percentage of participants	55.6 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.

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

Outcome measures
Measure	Placebo n=114 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 48 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) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=125 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Percentage of Participants Who Achieved ACR 70 Response at Weeks 24, 28, 36, 44 and 52 Week 24	6.1 percentage of participants	12.2 percentage of participants	20.8 percentage of participants
Percentage of Participants Who Achieved ACR 70 Response at Weeks 24, 28, 36, 44 and 52 Week 28	9.8 percentage of participants	20.5 percentage of participants	24.8 percentage of participants
Percentage of Participants Who Achieved ACR 70 Response at Weeks 24, 28, 36, 44 and 52 Week 36	18.0 percentage of participants	25.2 percentage of participants	26.4 percentage of participants
Percentage of Participants Who Achieved ACR 70 Response at Weeks 24, 28, 36, 44 and 52 Week 44	16.8 percentage of participants	28.4 percentage of participants	26.4 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	28.9 percentage of participants	29.8 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.

ACR components include swollen joint count (66 joints), tender joint count (68 joints), 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

Outcome measures
Measure	Placebo n=114 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 48 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) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=125 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 36: PtGA of Disease Activity	-26.51 percent change Standard Deviation 60.926	-46.03 percent change Standard Deviation 39.547	-45.17 percent change Standard Deviation 39.277
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 24: Swollen Joint Count	-48.33 percent change Standard Deviation 45.987	-66.62 percent change Standard Deviation 47.086	-73.23 percent change Standard Deviation 38.120
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 28: Swollen Joint Count	-59.95 percent change Standard Deviation 47.826	-75.42 percent change Standard Deviation 33.774	-80.93 percent change Standard Deviation 27.197
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 36: Swollen Joint Count	-70.50 percent change Standard Deviation 37.359	-79.16 percent change Standard Deviation 35.141	-80.19 percent change Standard Deviation 29.160
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 44: Swollen Joint Count	-72.63 percent change Standard Deviation 38.625	-80.35 percent change Standard Deviation 34.653	-82.46 percent change Standard Deviation 31.652
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 52: Swollen Joint Count	-78.23 percent change Standard Deviation 37.345	-79.63 percent change Standard Deviation 36.471	-86.73 percent change Standard Deviation 26.776
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 24: Tender Joint Count	-27.58 percent change Standard Deviation 53.737	-53.73 percent change Standard Deviation 45.118	-56.56 percent change Standard Deviation 41.774
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 28: Tender Joint Count	-42.99 percent change Standard Deviation 62.128	-64.03 percent change Standard Deviation 40.678	-66.68 percent change Standard Deviation 31.528
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 36: Tender Joint Count	-57.06 percent change Standard Deviation 43.351	-68.44 percent change Standard Deviation 39.771	-64.67 percent change Standard Deviation 41.606
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 44: Tender Joint Count	-60.08 percent change Standard Deviation 42.811	-69.23 percent change Standard Deviation 51.229	-71.90 percent change Standard Deviation 31.422
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 52: Tender Joint Count	-65.65 percent change Standard Deviation 37.682	-72.39 percent change Standard Deviation 35.102	-72.70 percent change Standard Deviation 37.487
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 24: Patient's Assessment of Pain	-6.05 percent change Standard Deviation 52.682	-32.65 percent change Standard Deviation 45.343	-38.90 percent change Standard Deviation 43.955
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 28: Patient's Assessment of Pain	-21.93 percent change Standard Deviation 52.597	-38.86 percent change Standard Deviation 45.149	-43.59 percent change Standard Deviation 39.524
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 36: Patient's Assessment of Pain	-27.61 percent change Standard Deviation 56.373	-42.85 percent change Standard Deviation 43.952	-47.23 percent change Standard Deviation 41.167
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 44: Patient's Assessment of Pain	-27.98 percent change Standard Deviation 64.080	-45.27 percent change Standard Deviation 47.794	-48.97 percent change Standard Deviation 36.509
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 52: Patient's Assessment of Pain	-35.64 percent change Standard Deviation 66.672	-42.67 percent change Standard Deviation 47.250	-50.03 percent change Standard Deviation 50.203
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 24: PtGA of Disease Activity	-7.63 percent change Standard Deviation 58.147	-37.16 percent change Standard Deviation 39.760	-40.27 percent change Standard Deviation 42.250
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 28: PtGA of Disease Activity	-21.74 percent change Standard Deviation 57.662	-45.35 percent change Standard Deviation 41.564	-37.62 percent change Standard Deviation 60.121
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 44: PtGA of Disease Activity	-21.76 percent change Standard Deviation 81.481	-46.11 percent change Standard Deviation 40.973	-45.84 percent change Standard Deviation 43.368
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 52: PtGA of Disease Activity	-35.17 percent change Standard Deviation 56.398	-45.84 percent change Standard Deviation 42.176	-47.85 percent change Standard Deviation 55.429
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 24: PGA of Disease Activity	-33.22 percent change Standard Deviation 34.014	-53.43 percent change Standard Deviation 37.305	-61.59 percent change Standard Deviation 31.445
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 28: PGA of Disease Activity	-53.88 percent change Standard Deviation 31.619	-57.70 percent change Standard Deviation 33.724	-65.96 percent change Standard Deviation 29.400
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 36: PGA of Disease Activity	-62.40 percent change Standard Deviation 29.215	-64.51 percent change Standard Deviation 34.389	-68.37 percent change Standard Deviation 27.206
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 44: PGA of Disease Activity	-64.93 percent change Standard Deviation 28.895	-69.08 percent change Standard Deviation 30.743	-72.65 percent change Standard Deviation 25.842
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 52: PGA of Disease Activity	-68.67 percent change Standard Deviation 32.861	-68.83 percent change Standard Deviation 32.776	-74.71 percent change Standard Deviation 25.456
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 24: HAQ-DI score	-7.65 percent change Standard Deviation 62.206	-8.80 percent change Standard Deviation 148.199	-31.18 percent change Standard Deviation 72.701
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 28: HAQ-DI score	-15.62 percent change Standard Deviation 51.720	-29.10 percent change Standard Deviation 60.044	-33.41 percent change Standard Deviation 72.942
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 36: HAQ-DI score	-15.37 percent change Standard Deviation 53.391	-29.43 percent change Standard Deviation 73.712	-32.74 percent change Standard Deviation 86.404
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 44: HAQ-DI score	-29.61 percent change Standard Deviation 45.603	-34.54 percent change Standard Deviation 73.685	-35.91 percent change Standard Deviation 80.885
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 52: HAQ-DI score	-28.42 percent change Standard Deviation 45.473	-31.09 percent change Standard Deviation 60.232	-46.13 percent change Standard Deviation 56.354
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 24: CRP	-13.58 percent change Standard Deviation 150.494	-7.83 percent change Standard Deviation 101.789	-6.48 percent change Standard Deviation 149.288
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 28: CRP	-8.67 percent change Standard Deviation 122.851	-5.58 percent change Standard Deviation 99.590	-10.30 percent change Standard Deviation 97.703
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 36: CRP	-17.33 percent change Standard Deviation 102.168	-31.55 percent change Standard Deviation 50.560	-14.65 percent change Standard Deviation 113.746
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 44: CRP	-29.10 percent change Standard Deviation 70.460	-17.81 percent change Standard Deviation 76.247	-4.39 percent change Standard Deviation 190.368
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 Week 52: CRP	-1.68 percent change Standard Deviation 167.086	-19.28 percent change Standard Deviation 69.875	-15.76 percent change Standard Deviation 129.101

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

Outcome measures
Measure	Placebo n=114 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 48 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) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=125 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Change From Baseline in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52 Week 24	-0.1217 units on a scale Standard Deviation 0.52442	-0.3374 units on a scale Standard Deviation 0.56967	-0.3740 units on a scale Standard Deviation 0.45914
Change From Baseline in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52 Week 28	-0.2241 units on a scale Standard Deviation 0.50876	-0.4004 units on a scale Standard Deviation 0.52303	-0.3850 units on a scale Standard Deviation 0.46381
Change From Baseline in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52 Week 36	-0.2602 units on a scale Standard Deviation 0.51278	-0.4396 units on a scale Standard Deviation 0.54426	-0.4132 units on a scale Standard Deviation 0.47155
Change From Baseline in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52 Week 44	-0.3634 units on a scale Standard Deviation 0.53486	-0.4672 units on a scale Standard Deviation 0.57140	-0.4180 units on a scale Standard Deviation 0.51394
Change From Baseline in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52 Week 52	-0.3642 units on a scale Standard Deviation 0.51084	-0.4364 units on a scale Standard Deviation 0.56400	-0.4970 units on a scale Standard Deviation 0.47990

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. 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

Outcome measures
Measure	Placebo n=100 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=109 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=109 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
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	36.0 percentage of participants	53.2 percentage of participants	57.8 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	40.2 percentage of participants	61.5 percentage of participants	61.5 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	41.7 percentage of participants	60.4 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	50.0 percentage of participants	58.7 percentage of participants	62.4 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	54.3 percentage of participants	57.4 percentage of participants	68.5 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

Outcome measures
Measure	Placebo n=114 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 48 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) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=125 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Change From Baseline in DAS28 (CRP) Score at Weeks 24, 28, 36, 44 and 52 Week 24	-0.84 units on a scale Standard Deviation 1.043	-1.49 units on a scale Standard Deviation 1.140	-1.57 units on a scale Standard Deviation 1.045
Change From Baseline in DAS28 (CRP) Score at Weeks 24, 28, 36, 44 and 52 Week 28	-1.33 units on a scale Standard Deviation 1.121	-1.71 units on a scale Standard Deviation 1.126	-1.67 units on a scale Standard Deviation 1.020
Change From Baseline in DAS28 (CRP) Score at Weeks 24, 28, 36, 44 and 52 Week 36	-1.60 units on a scale Standard Deviation 1.123	-1.96 units on a scale Standard Deviation 1.145	-1.78 units on a scale Standard Deviation 1.054
Change From Baseline in DAS28 (CRP) Score at Weeks 24, 28, 36, 44 and 52 Week 44	-1.69 units on a scale Standard Deviation 1.224	-1.96 units on a scale Standard Deviation 1.226	-1.92 units on a scale Standard Deviation 1.116
Change From Baseline in DAS28 (CRP) Score at Weeks 24, 28, 36, 44 and 52 Week 52	-1.84 units on a scale Standard Deviation 1.087	-2.03 units on a scale Standard Deviation 1.250	-1.99 units on a scale Standard Deviation 1.062

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

Outcome measures
Measure	Placebo n=114 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 48 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) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=125 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 24, 28, 36, 44 and 52 Week 24	51.8 percentage of participants	74.6 percentage of participants	78.4 percentage of participants
Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 24, 28, 36, 44 and 52 Week 28	73.6 percentage of participants	83.3 percentage of participants	83.9 percentage of participants
Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 24, 28, 36, 44 and 52 Week 36	76.4 percentage of participants	89.0 percentage of participants	86.8 percentage of participants
Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 24, 28, 36, 44 and 52 Week 44	80.0 percentage of participants	86.8 percentage of participants	89.5 percentage of participants
Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 24, 28, 36, 44 and 52 Week 52	86.4 percentage of participants	88.4 percentage of participants	87.8 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

Outcome measures
Measure	Placebo n=114 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 48 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) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=125 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 24, 28, 36, 44 and 52 Week 24	14.9 percentage of participants	24.6 percentage of participants	36.8 percentage of participants
Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 24, 28, 36, 44 and 52 Week 28	26.4 percentage of participants	37.5 percentage of participants	38.7 percentage of participants
Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 24, 28, 36, 44 and 52 Week 36	39.1 percentage of participants	40.7 percentage of participants	40.5 percentage of participants
Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 24, 28, 36, 44 and 52 Week 44	38.1 percentage of participants	45.6 percentage of participants	51.6 percentage of participants
Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 24, 28, 36, 44 and 52 Week 52	37.9 percentage of participants	43.8 percentage of participants	56.1 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 outcome measure (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

Outcome measures
Measure	Placebo n=53 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 48 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) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
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	84.9 percentage of participants	87.3 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.

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

Outcome measures
Measure	Placebo n=114 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 48 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) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=125 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
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	37.2 percentage of participants	63.1 percentage of participants	74.4 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	64.9 percentage of participants	78.7 percentage of participants	82.3 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 36	68.8 percentage of participants	80.5 percentage of participants	80.0 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	73.8 percentage of participants	81.9 percentage of participants	80.0 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	73.8 percentage of participants	83.8 percentage of participants	83.9 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

Outcome measures
Measure	Placebo n=114 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 48 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) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=125 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Change From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 24, 28, 36, 44 and 52 Week 52	-26.058 units on a scale Standard Deviation 18.6507	-30.906 units on a scale Standard Deviation 23.0188	-26.562 units on a scale Standard Deviation 15.1985
Change From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 24, 28, 36, 44 and 52 Week 24	-12.962 units on a scale Standard Deviation 17.9137	-23.373 units on a scale Standard Deviation 20.2784	-20.530 units on a scale Standard Deviation 13.2678
Change From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 24, 28, 36, 44 and 52 Week 28	-18.632 units on a scale Standard Deviation 19.4997	-26.790 units on a scale Standard Deviation 19.3655	-22.766 units on a scale Standard Deviation 12.8366
Change From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 24, 28, 36, 44 and 52 Week 36	-22.360 units on a scale Standard Deviation 18.8976	-30.070 units on a scale Standard Deviation 21.0899	-24.067 units on a scale Standard Deviation 14.0976
Change From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 24, 28, 36, 44 and 52 Week 44	-23.602 units on a scale Standard Deviation 19.9198	-30.312 units on a scale Standard Deviation 22.5854	-26.010 units on a scale Standard Deviation 15.3230

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

Outcome measures
Measure	Placebo n=68 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=82 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=88 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
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 at Baseline Week 24	8.8 percentage of participants	50.6 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 at Baseline Week 52	69.2 percentage of participants	70.7 percentage of participants	79.5 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.

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

Outcome measures
Measure	Placebo n=68 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=82 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=88 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
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 at Baseline Week 24	10.3 percentage of participants	40.7 percentage of participants	53.4 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 at Baseline Week 52	64.6 percentage of participants	58.7 percentage of participants	73.9 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 severity. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. Negative changes from baseline indicate improvement of psoriasis.

Outcome measures

Outcome measures
Measure	Placebo n=68 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=82 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=88 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Change From Baseline in PASI Score at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline Week 24	-3.046 units on a scale Standard Deviation 9.3053	-9.968 units on a scale Standard Deviation 10.0178	-11.614 units on a scale Standard Deviation 10.3771
Change From Baseline in PASI Score at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline Week 52	-10.565 units on a scale Standard Deviation 8.8792	-10.431 units on a scale Standard Deviation 11.0277	-11.988 units on a scale Standard Deviation 10.3067

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

Outcome measures
Measure	Placebo n=68 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=82 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=88 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
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 at Baseline Week 24	20.6 percentage of participants	76.5 percentage of participants	87.5 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 at Baseline Week 52	84.8 percentage of participants	80.0 percentage of participants	94.3 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 90 response: \>=90% improvement in PASI score from baseline.

Outcome measures

Outcome measures
Measure	Placebo n=68 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=82 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=88 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
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 at Baseline Week 24	13.2 percentage of participants	50.6 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 at Baseline Week 52	72.7 percentage of participants	66.7 percentage of participants	76.1 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

Outcome measures
Measure	Placebo n=68 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=82 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=88 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
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 at Baseline Week 52	62.1 percentage of participants	48.0 percentage of participants	64.8 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 at Baseline Week 24	7.4 percentage of participants	25.9 percentage of participants	45.5 percentage of participants

SECONDARY outcome

Timeframe: Weeks 24, 36 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

Outcome measures
Measure	Placebo n=114 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 48 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) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=125 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Percentage of Participants Who Achieved >=5 Point Improvement From Baseline in SF-36 PCS Score at Weeks 24, 36 and 52 Week 24	35.1 percentage of participants	53.7 percentage of participants	55.6 percentage of participants
Percentage of Participants Who Achieved >=5 Point Improvement From Baseline in SF-36 PCS Score at Weeks 24, 36 and 52 Week 36	44.9 percentage of participants	53.8 percentage of participants	55.0 percentage of participants
Percentage of Participants Who Achieved >=5 Point Improvement From Baseline in SF-36 PCS Score at Weeks 24, 36 and 52 Week 52	52.9 percentage of participants	53.5 percentage of participants	62.9 percentage of participants

SECONDARY outcome

Timeframe: Weeks 24, 36 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

Outcome measures
Measure	Placebo n=114 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 48 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) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=125 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Percentage of Participants Who Achieved >=5 Point Improvement From Baseline in SF-36 MCS Score at Weeks 24, 36 and 52 Week 24	29.8 percentage of participants	39.0 percentage of participants	44.4 percentage of participants
Percentage of Participants Who Achieved >=5 Point Improvement From Baseline in SF-36 MCS Score at Weeks 24, 36 and 52 Week 36	39.3 percentage of participants	39.5 percentage of participants	49.2 percentage of participants
Percentage of Participants Who Achieved >=5 Point Improvement From Baseline in SF-36 MCS Score at Weeks 24, 36 and 52 Week 52	37.5 percentage of participants	46.5 percentage of participants	47.6 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

Outcome measures
Measure	Placebo n=114 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 48 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) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=125 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 24 and 52 Week 24	12.3 percentage of participants	23.6 percentage of participants	31.2 percentage of participants
Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 24 and 52 Week 52	31.1 percentage of participants	33.9 percentage of participants	40.3 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

Outcome measures
Measure	Placebo n=114 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 48 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) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=125 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
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	-0.998 units on a scale Standard Deviation 1.4808	-2.493 units on a scale Standard Deviation 1.5195	-2.751 units on a scale Standard Deviation 1.5060
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	-2.829 units on a scale Standard Deviation 1.5773	-3.112 units on a scale Standard Deviation 1.7479	-3.364 units on a scale Standard Deviation 1.4638

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 compositive 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 (0-6), tender dactylitis count (scoring each digit from 0-3 and recoding to 0-1, where any score \> 0 equaled 1), and the PCS score 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

Outcome measures
Measure	Placebo n=114 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 48 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) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=125 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Change From Baseline in Psoriatic Arthritis Disease Activity (PASDAS) Score at Weeks 24 and 52 Week 24	-1.140 units on a scale Standard Deviation 1.4036	-2.246 units on a scale Standard Deviation 1.4978	-2.413 units on a scale Standard Deviation 1.3906
Change From Baseline in Psoriatic Arthritis Disease Activity (PASDAS) Score at Weeks 24 and 52 Week 52	-2.748 units on a scale Standard Deviation 1.4706	-2.897 units on a scale Standard Deviation 1.6788	-3.026 units on a scale Standard Deviation 1.4446

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

Outcome measures
Measure	Placebo n=61 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=76 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Percentage of Participants Who Maintained an ACR 20 Response at Week 52 Among Participants Who Achieved an ACR 20 Response at Week 24	88.5 percentage of participants	90.8 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

Outcome measures
Measure	Placebo n=37 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=46 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Percentage of Participants Who Maintained an ACR 50 Response at Week 52 Among Participants Who Achieved an ACR 50 Response at Week 24	83.8 percentage of participants	91.3 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

Outcome measures
Measure	Placebo n=15 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=26 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Percentage of Participants Who Maintained an ACR 70 Response at Week 52 Among Participants Who Achieved an ACR 70 Response at Week 24	80.0 percentage of participants	84.6 percentage of participants	—

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 with peripheral arthritis as their primary arthritic presentation of PsA completed the BASDAI indicate the degree of their symptoms over the past week.

Outcome measures

Outcome measures
Measure	Placebo n=21 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=24 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=20 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 24 and 52 Among Participants With Spondylitis and Peripheral Arthritis as Their Primary Arthritic Presentation of PsA Week 24: Participants with >=20% Improvement	38.1 percentage of participants	70.8 percentage of participants	65.0 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 Participants With Spondylitis and Peripheral Arthritis as Their Primary Arthritic Presentation of PsA Week 24: Participants with >=70% Improvement	14.3 percentage of participants	29.2 percentage of participants	5.0 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 Participants With Spondylitis and Peripheral Arthritis as Their Primary Arthritic Presentation of PsA Week 24: Participants with >=90% Improvement	0 percentage of participants	16.7 percentage of participants	0 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 Participants With Spondylitis and Peripheral Arthritis as Their Primary Arthritic Presentation of PsA Week 52: Participants with >=50% Improvement	52.4 percentage of participants	59.1 percentage of participants	50.0 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 Participants With Spondylitis and Peripheral Arthritis as Their Primary Arthritic Presentation of PsA Week 52: Participants with >=70% Improvement	28.6 percentage of participants	40.9 percentage of participants	20.0 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 Participants With Spondylitis and Peripheral Arthritis as Their Primary Arthritic Presentation of PsA Week 52: Participants with >=90% Improvement	9.5 percentage of participants	13.6 percentage of participants	15.0 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 Participants With Spondylitis and Peripheral Arthritis as Their Primary Arthritic Presentation of PsA Week 52: Participants with >=20% Improvement	66.7 percentage of participants	72.7 percentage of participants	85.0 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 Participants With Spondylitis and Peripheral Arthritis as Their Primary Arthritic Presentation of PsA Week 24: Participants with >=50% Improvement	19.0 percentage of participants	41.7 percentage of participants	35.0 percentage of participants

SECONDARY outcome

Timeframe: Weeks 24, 36, 44 and 52

Population: Analysis population is FAS2 among the participants with enthesitis (LEI) at baseline who achieved resolution of enthesitis at Week 24. Here, N (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 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

Outcome measures
Measure	Placebo n=71 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=71 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=71 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Percentage of Participants With Resolution of Enthesitis at Weeks 24, 36, 44 and 52 Among the Participants With Enthesitis at Baseline Week 36	49.3 percentage of participants	52.9 percentage of participants	58.0 percentage of participants
Percentage of Participants With Resolution of Enthesitis at Weeks 24, 36, 44 and 52 Among the Participants With Enthesitis at Baseline Week 52	69.8 percentage of participants	56.3 percentage of participants	62.9 percentage of participants
Percentage of Participants With Resolution of Enthesitis at Weeks 24, 36, 44 and 52 Among the Participants With Enthesitis at Baseline Week 24	31.0 percentage of participants	40.8 percentage of participants	49.3 percentage of participants
Percentage of Participants With Resolution of Enthesitis at Weeks 24, 36, 44 and 52 Among the Participants With Enthesitis at Baseline Week 44	58.2 percentage of participants	46.4 percentage of participants	71.8 percentage of participants

SECONDARY outcome

Timeframe: Weeks 24, 36, 44 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

Outcome measures
Measure	Placebo n=47 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=49 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=37 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Percentage of Participants With Resolution of Dactylitis at Weeks 24, 36, 44 and 52 Among Participants With Dactylitis at Baseline Week 24	61.7 percentage of participants	67.3 percentage of participants	64.9 percentage of participants
Percentage of Participants With Resolution of Dactylitis at Weeks 24, 36, 44 and 52 Among Participants With Dactylitis at Baseline Week 36	79.5 percentage of participants	67.4 percentage of participants	82.9 percentage of participants
Percentage of Participants With Resolution of Dactylitis at Weeks 24, 36, 44 and 52 Among Participants With Dactylitis at Baseline Week 44	84.8 percentage of participants	76.1 percentage of participants	83.8 percentage of participants
Percentage of Participants With Resolution of Dactylitis at Weeks 24, 36, 44 and 52 Among Participants With Dactylitis at Baseline Week 52	81.4 percentage of participants	79.5 percentage of participants	78.4 percentage of participants

SECONDARY outcome

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

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

Enthesitis was assessed using the Spondyloarthritis Research Consortium of Canada (SPARCC). The SPARCC developed a measure for enthesitis in general spondyloarthritis which evaluates the presence or absence of pain by applying local pressure to the following entheses: supraspinatus insertion (left and right), medial epicondyle humerus (left and right), lateral epicondyle humerus (left and right), greater trochanter (left and right), quadriceps-to-patella (left and right), patellar-tibia (left and right), achilles tendon insertion (left and right), plantar fascia (left and right). Tenderness on examination was recorded as either present (1) or absent (0) for each of the 16 sites for an overall score range of 0-16. Higher scores indicate more severe enthesitis. Negative changes from baseline indicate improvement of enthesitis.

Outcome measures

Outcome measures
Measure	Placebo n=77 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=85 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=82 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Change From Baseline in Enthesitis Score (Based on SPARCC) at Weeks 24, 36, 44 and 52 Among the Participants With Enthesitis at Baseline Week 24	-1.9 units on a scale Standard Deviation 3.55	-2.7 units on a scale Standard Deviation 3.68	-3.0 units on a scale Standard Deviation 3.60
Change From Baseline in Enthesitis Score (Based on SPARCC) at Weeks 24, 36, 44 and 52 Among the Participants With Enthesitis at Baseline Week 36	-3.1 units on a scale Standard Deviation 3.61	-3.4 units on a scale Standard Deviation 3.90	-3.6 units on a scale Standard Deviation 3.52
Change From Baseline in Enthesitis Score (Based on SPARCC) at Weeks 24, 36, 44 and 52 Among the Participants With Enthesitis at Baseline Week 44	-3.6 units on a scale Standard Deviation 3.67	-3.6 units on a scale Standard Deviation 3.82	-4.1 units on a scale Standard Deviation 3.55
Change From Baseline in Enthesitis Score (Based on SPARCC) at Weeks 24, 36, 44 and 52 Among the Participants With Enthesitis at Baseline Week 52	-3.9 units on a scale Standard Deviation 3.57	-4.1 units on a scale Standard Deviation 4.04	-4.0 units on a scale Standard Deviation 3.51

SECONDARY outcome

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

Population: Analysis population is FAS2 among the participants with enthesitis (LEI) at baseline. Here, N (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 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

Outcome measures
Measure	Placebo n=71 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=71 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=71 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 24, 36, 44 and 52 Among the Participants With Enthesitis at Baseline Week 24	-1.0 units on a scale Standard Deviation 1.68	-1.2 units on a scale Standard Deviation 1.95	-1.8 units on a scale Standard Deviation 1.93
Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 24, 36, 44 and 52 Among the Participants With Enthesitis at Baseline Week 36	-1.4 units on a scale Standard Deviation 1.73	-1.3 units on a scale Standard Deviation 2.04	-2.0 units on a scale Standard Deviation 1.68
Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 24, 36, 44 and 52 Among the Participants With Enthesitis at Baseline Week 44	-1.6 units on a scale Standard Deviation 1.90	-1.6 units on a scale Standard Deviation 1.70	-2.4 units on a scale Standard Deviation 1.68
Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 24, 36, 44 and 52 Among the Participants With Enthesitis at Baseline Week 52	-1.9 units on a scale Standard Deviation 1.65	-1.8 units on a scale Standard Deviation 1.66	-2.0 units on a scale Standard Deviation 1.87

SECONDARY outcome

Timeframe: Baseline, Weeks 24, 36, 44 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

Outcome measures
Measure	Placebo n=47 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=49 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=37 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Change From Baseline in Dactylitis Score at Weeks 24, 36, 44 and 52 Among the Participants With Dactylitis at Baseline Week 52	-5.7 units on a scale Standard Deviation 5.86	-7.8 units on a scale Standard Deviation 10.55	-7.6 units on a scale Standard Deviation 10.91
Change From Baseline in Dactylitis Score at Weeks 24, 36, 44 and 52 Among the Participants With Dactylitis at Baseline Week 24	-4.0 units on a scale Standard Deviation 6.08	-6.2 units on a scale Standard Deviation 10.31	-6.6 units on a scale Standard Deviation 11.08
Change From Baseline in Dactylitis Score at Weeks 24, 36, 44 and 52 Among the Participants With Dactylitis at Baseline Week 36	-6.0 units on a scale Standard Deviation 7.17	-6.4 units on a scale Standard Deviation 10.91	-7.7 units on a scale Standard Deviation 11.58
Change From Baseline in Dactylitis Score at Weeks 24, 36, 44 and 52 Among the Participants With Dactylitis at Baseline Week 44	-5.3 units on a scale Standard Deviation 5.61	-7.2 units on a scale Standard Deviation 10.57	-7.5 units on a scale Standard Deviation 11.41

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.

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

Outcome measures
Measure	Placebo n=68 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 48 in the active treatment period.	Guselkumab 100 mg q8w n=82 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=88 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Percentage of Participants With an IGA Score of 0 (Cleared) or 1 (Cleared) at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline Week 24	8.8 percentage of participants	38.3 percentage of participants	54.5 percentage of participants
Percentage of Participants With an IGA Score of 0 (Cleared) or 1 (Cleared) at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline Week 52	66.2 percentage of participants	53.3 percentage of participants	67.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 24, 36 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

Outcome measures
Measure	Placebo n=114 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 48 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) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=125 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Change From Baseline in SF-36 Physical Component Summary (PCS) Score at Weeks 24, 36 and 52 Week 24	2.700 units on a scale Standard Deviation 7.1649	6.505 units on a scale Standard Deviation 7.7137	6.560 units on a scale Standard Deviation 7.7566
Change From Baseline in SF-36 Physical Component Summary (PCS) Score at Weeks 24, 36 and 52 Week 36	5.456 units on a scale Standard Deviation 8.0353	7.439 units on a scale Standard Deviation 8.5626	7.162 units on a scale Standard Deviation 7.9890
Change From Baseline in SF-36 Physical Component Summary (PCS) Score at Weeks 24, 36 and 52 Week 52	6.905 units on a scale Standard Deviation 7.9376	7.278 units on a scale Standard Deviation 8.0648	8.517 units on a scale Standard Deviation 8.2717

SECONDARY outcome

Timeframe: Baseline, Weeks 24, 36 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

Outcome measures
Measure	Placebo n=114 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 48 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) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=125 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Change From Baseline in SF-36 Mental Component Summary (MCS) Score at Weeks 24, 36 and 52 Week 24	1.827 units on a scale Standard Deviation 8.1508	3.027 units on a scale Standard Deviation 10.6157	3.796 units on a scale Standard Deviation 8.7396
Change From Baseline in SF-36 Mental Component Summary (MCS) Score at Weeks 24, 36 and 52 Week 36	3.612 units on a scale Standard Deviation 7.2322	4.300 units on a scale Standard Deviation 10.2373	4.326 units on a scale Standard Deviation 9.2709
Change From Baseline in SF-36 Mental Component Summary (MCS) Score at Weeks 24, 36 and 52 Week 52	4.240 units on a scale Standard Deviation 8.1200	5.139 units on a scale Standard Deviation 9.1719	4.931 units on a scale Standard Deviation 8.9482

SECONDARY outcome

Timeframe: Baseline, Weeks 24, 36 and 52

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

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

Outcome measures
Measure	Placebo n=114 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 48 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) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=125 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Change From Baseline in Norm Based Scores of SF-36 Scales at Week 24, 36 and 52 Week 52: Bodily Pain	8.331 units on a scale Standard Deviation 8.1585	8.781 units on a scale Standard Deviation 8.5691	8.958 units on a scale Standard Deviation 9.1783
Change From Baseline in Norm Based Scores of SF-36 Scales at Week 24, 36 and 52 Week 24: Social Function	2.419 units on a scale Standard Deviation 8.8289	5.666 units on a scale Standard Deviation 9.3449	4.932 units on a scale Standard Deviation 9.5887
Change From Baseline in Norm Based Scores of SF-36 Scales at Week 24, 36 and 52 Week 52: Social Function	5.351 units on a scale Standard Deviation 8.9264	6.729 units on a scale Standard Deviation 8.4844	6.428 units on a scale Standard Deviation 10.1397
Change From Baseline in Norm Based Scores of SF-36 Scales at Week 24, 36 and 52 Week 36: Role-emotional	3.580 units on a scale Standard Deviation 8.5353	4.301 units on a scale Standard Deviation 10.1127	3.685 units on a scale Standard Deviation 10.5307
Change From Baseline in Norm Based Scores of SF-36 Scales at Week 24, 36 and 52 Week 52: Role-emotional	4.520 units on a scale Standard Deviation 8.8658	4.979 units on a scale Standard Deviation 10.2956	4.830 units on a scale Standard Deviation 9.9053
Change From Baseline in Norm Based Scores of SF-36 Scales at Week 24, 36 and 52 Week 36: Mental Health	3.472 units on a scale Standard Deviation 7.0761	5.056 units on a scale Standard Deviation 9.7930	5.559 units on a scale Standard Deviation 8.9957
Change From Baseline in Norm Based Scores of SF-36 Scales at Week 24, 36 and 52 Week 52: Mental Health	4.251 units on a scale Standard Deviation 8.3059	5.553 units on a scale Standard Deviation 8.4255	6.223 units on a scale Standard Deviation 8.8360
Change From Baseline in Norm Based Scores of SF-36 Scales at Week 24, 36 and 52 Week 24: Physical Functioning	1.914 units on a scale Standard Deviation 8.8644	6.006 units on a scale Standard Deviation 7.9608	6.652 units on a scale Standard Deviation 8.4730
Change From Baseline in Norm Based Scores of SF-36 Scales at Week 24, 36 and 52 Week 36: Physical Functioning	5.008 units on a scale Standard Deviation 8.6461	6.900 units on a scale Standard Deviation 8.5458	7.114 units on a scale Standard Deviation 8.8941
Change From Baseline in Norm Based Scores of SF-36 Scales at Week 24, 36 and 52 Week 52: Physical Functioning	6.257 units on a scale Standard Deviation 8.3753	7.000 units on a scale Standard Deviation 8.0953	8.720 units on a scale Standard Deviation 8.9738
Change From Baseline in Norm Based Scores of SF-36 Scales at Week 24, 36 and 52 Week 24: Role-physical	3.053 units on a scale Standard Deviation 7.6460	5.239 units on a scale Standard Deviation 8.2864	5.215 units on a scale Standard Deviation 7.5241
Change From Baseline in Norm Based Scores of SF-36 Scales at Week 24, 36 and 52 Week 36: Role-physical	4.701 units on a scale Standard Deviation 8.1572	6.245 units on a scale Standard Deviation 7.8346	6.250 units on a scale Standard Deviation 7.9040
Change From Baseline in Norm Based Scores of SF-36 Scales at Week 24, 36 and 52 Week 52: Role-physical	5.873 units on a scale Standard Deviation 8.8847	6.126 units on a scale Standard Deviation 8.1008	7.063 units on a scale Standard Deviation 8.2579
Change From Baseline in Norm Based Scores of SF-36 Scales at Week 24, 36 and 52 Week 24: Bodily Pain	3.388 units on a scale Standard Deviation 7.2056	7.058 units on a scale Standard Deviation 8.8315	7.215 units on a scale Standard Deviation 9.1129
Change From Baseline in Norm Based Scores of SF-36 Scales at Week 24, 36 and 52 Week 36: Bodily Pain	6.477 units on a scale Standard Deviation 8.6363	8.487 units on a scale Standard Deviation 8.8135	7.348 units on a scale Standard Deviation 9.0965
Change From Baseline in Norm Based Scores of SF-36 Scales at Week 24, 36 and 52 Week 24: General Health	1.819 units on a scale Standard Deviation 6.9497	4.361 units on a scale Standard Deviation 7.5573	5.066 units on a scale Standard Deviation 7.1334
Change From Baseline in Norm Based Scores of SF-36 Scales at Week 24, 36 and 52 Week 36: General Health	3.742 units on a scale Standard Deviation 8.2079	5.638 units on a scale Standard Deviation 8.4919	5.540 units on a scale Standard Deviation 7.4840
Change From Baseline in Norm Based Scores of SF-36 Scales at Week 24, 36 and 52 Week 52: General Health	4.677 units on a scale Standard Deviation 7.8944	5.547 units on a scale Standard Deviation 7.8712	6.442 units on a scale Standard Deviation 7.9374
Change From Baseline in Norm Based Scores of SF-36 Scales at Week 24, 36 and 52 Week 24: Vitality	2.684 units on a scale Standard Deviation 9.0049	5.652 units on a scale Standard Deviation 9.6943	6.158 units on a scale Standard Deviation 7.8842
Change From Baseline in Norm Based Scores of SF-36 Scales at Week 24, 36 and 52 Week 36: Vitality	6.303 units on a scale Standard Deviation 9.0307	7.065 units on a scale Standard Deviation 8.6659	7.353 units on a scale Standard Deviation 8.7656
Change From Baseline in Norm Based Scores of SF-36 Scales at Week 24, 36 and 52 Week 52: Vitality	7.742 units on a scale Standard Deviation 8.7476	7.558 units on a scale Standard Deviation 9.1600	8.218 units on a scale Standard Deviation 8.5308
Change From Baseline in Norm Based Scores of SF-36 Scales at Week 24, 36 and 52 Week 36: Social Function	4.873 units on a scale Standard Deviation 9.1477	5.899 units on a scale Standard Deviation 9.9762	5.598 units on a scale Standard Deviation 10.5240
Change From Baseline in Norm Based Scores of SF-36 Scales at Week 24, 36 and 52 Week 24: Role-emotional	1.833 units on a scale Standard Deviation 9.0800	2.265 units on a scale Standard Deviation 10.6155	3.706 units on a scale Standard Deviation 9.3529
Change From Baseline in Norm Based Scores of SF-36 Scales at Week 24, 36 and 52 Week 24: Mental Health	1.905 units on a scale Standard Deviation 8.1196	4.062 units on a scale Standard Deviation 10.0610	4.873 units on a scale Standard Deviation 8.6431

SECONDARY outcome

Timeframe: Baseline, Weeks 24, 36 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

Outcome measures
Measure	Placebo n=114 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 48 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) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=125 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 24, 36 and 52 Week 24	2.605 units on a scale Standard Deviation 8.3142	5.862 units on a scale Standard Deviation 10.3941	5.576 units on a scale Standard Deviation 7.7670
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 24, 36 and 52 Week 36	5.981 units on a scale Standard Deviation 8.3846	7.252 units on a scale Standard Deviation 9.7182	5.917 units on a scale Standard Deviation 8.5123
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 24, 36 and 52 Week 52	6.577 units on a scale Standard Deviation 9.4105	7.482 units on a scale Standard Deviation 9.6342	6.911 units on a scale Standard Deviation 8.3986

SECONDARY outcome

Timeframe: Weeks 24, 36 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

Outcome measures
Measure	Placebo n=114 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 48 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) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=125 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score at Weeks 24, 36 and 52 Week 24	41.2 percentage of participants	55.3 percentage of participants	64.8 percentage of participants
Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score at Weeks 24, 36 and 52 Week 36	60.7 percentage of participants	58.0 percentage of participants	66.1 percentage of participants
Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score at Weeks 24, 36 and 52 Week 52	63.5 percentage of participants	61.4 percentage of participants	63.7 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 24, 36 and 52

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

PROMIS-29 contains 4 items for each of seven PROMIS domains (Anxiety, Depression, Fatigue, Pain Interference, Physical Function, Sleep Disturbance, and Satisfaction-Social Role and Activity. PROMIS-29 also includes an additional pain intensity 0-10 NRS. The raw score of each domain is converted into a standardized score with a mean of 50 and a SD of 10 for the general population in the US (T-Score).

Outcome measures

Outcome measures
Measure	Placebo n=114 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 48 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) and placebo matched to guselkumab injections at other visits through Week 48.	Guselkumab 100 mg q4w n=125 Participants Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Scores at Weeks 24, 36 and 52 Week 36: Physical Function Score	3.093 T-score Standard Deviation 6.5712	4.970 T-score Standard Deviation 7.0012	5.264 T-score Standard Deviation 7.0643
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Scores at Weeks 24, 36 and 52 Week 52: Physical Function Score	4.245 T-score Standard Deviation 6.1363	5.033 T-score Standard Deviation 7.0184	5.920 T-score Standard Deviation 6.9852
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Scores at Weeks 24, 36 and 52 Week 24: Sleep Disturbance Score	-1.497 T-score Standard Deviation 5.7591	-3.750 T-score Standard Deviation 6.8758	-2.549 T-score Standard Deviation 6.7263
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Scores at Weeks 24, 36 and 52 Week 24: Anxiety Score	-1.482 T-score Standard Deviation 8.3526	-3.680 T-score Standard Deviation 9.8122	-3.115 T-score Standard Deviation 7.9491
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Scores at Weeks 24, 36 and 52 Week 52: Anxiety Score	-3.640 T-score Standard Deviation 8.3601	-4.279 T-score Standard Deviation 9.6488	-3.075 T-score Standard Deviation 8.5784
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Scores at Weeks 24, 36 and 52 Week 24: Depression Score	-0.601 T-score Standard Deviation 8.3133	-3.963 T-score Standard Deviation 8.5473	-2.706 T-score Standard Deviation 8.1872
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Scores at Weeks 24, 36 and 52 Week 36: Depression Score	-0.933 T-score Standard Deviation 7.1629	-3.916 T-score Standard Deviation 8.6211	-2.987 T-score Standard Deviation 7.8786
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Scores at Weeks 24, 36 and 52 Week 52: Pain Interference Score	-6.334 T-score Standard Deviation 6.9940	-6.972 T-score Standard Deviation 8.2440	-6.242 T-score Standard Deviation 7.4767
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Scores at Weeks 24, 36 and 52 Week 36: Sleep Disturbance Score	-2.767 T-score Standard Deviation 5.7630	-3.853 T-score Standard Deviation 6.5505	-4.096 T-score Standard Deviation 6.8724
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Scores at Weeks 24, 36 and 52 Week24:Satisfaction-Social Role and Activity Score	1.666 T-score Standard Deviation 7.2572	5.308 T-score Standard Deviation 8.5808	4.235 T-score Standard Deviation 7.4745
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Scores at Weeks 24, 36 and 52 Week52:Satisfaction-Social Role and Activity Score	4.885 T-score Standard Deviation 8.7421	6.607 T-score Standard Deviation 7.8438	5.347 T-score Standard Deviation 8.1806
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Scores at Weeks 24, 36 and 52 Week 24: Pain Intensity Score	-0.737 T-score Standard Deviation 2.0911	-2.098 T-score Standard Deviation 2.4104	-2.320 T-score Standard Deviation 2.4449
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Scores at Weeks 24, 36 and 52 Week 36: Pain Intensity Score	-1.720 T-score Standard Deviation 2.3424	-2.496 T-score Standard Deviation 2.4212	-2.488 T-score Standard Deviation 2.4018
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Scores at Weeks 24, 36 and 52 Week 36: Anxiety Score	-2.410 T-score Standard Deviation 7.6503	-3.929 T-score Standard Deviation 8.9614	-2.961 T-score Standard Deviation 8.4679
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Scores at Weeks 24, 36 and 52 Week 52: Depression Score	-2.488 T-score Standard Deviation 7.8259	-4.004 T-score Standard Deviation 7.5271	-2.985 T-score Standard Deviation 8.0519
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Scores at Weeks 24, 36 and 52 Week 24: Fatigue Score	-2.104 T-score Standard Deviation 7.5625	-4.780 T-score Standard Deviation 9.7044	-4.757 T-score Standard Deviation 7.7779
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Scores at Weeks 24, 36 and 52 Week 36: Fatigue Score	-5.533 T-score Standard Deviation 8.3256	-5.857 T-score Standard Deviation 8.8525	-5.693 T-score Standard Deviation 9.3854
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Scores at Weeks 24, 36 and 52 Week 52: Fatigue Score	-5.720 T-score Standard Deviation 9.0165	-6.773 T-score Standard Deviation 8.5608	-5.583 T-score Standard Deviation 8.1099
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Scores at Weeks 24, 36 and 52 Week 24: Pain Interference Score	-2.811 T-score Standard Deviation 5.9890	-5.810 T-score Standard Deviation 7.5201	-5.423 T-score Standard Deviation 7.1593
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Scores at Weeks 24, 36 and 52 Week 36: Pain Interference Score	-5.344 T-score Standard Deviation 7.2500	-6.754 T-score Standard Deviation 8.0520	-5.882 T-score Standard Deviation 7.5121
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Scores at Weeks 24, 36 and 52 Week 24: Physical Function Score	1.682 T-score Standard Deviation 5.9909	4.101 T-score Standard Deviation 7.1353	5.030 T-score Standard Deviation 6.5259
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Scores at Weeks 24, 36 and 52 Week 52: Sleep Disturbance Score	-3.290 T-score Standard Deviation 5.8368	-4.375 T-score Standard Deviation 6.5738	-3.856 T-score Standard Deviation 6.1181
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Scores at Weeks 24, 36 and 52 Week36:Satisfaction-Social Role and Activity Score	4.120 T-score Standard Deviation 8.1899	6.270 T-score Standard Deviation 8.8798	4.517 T-score Standard Deviation 7.9605
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Scores at Weeks 24, 36 and 52 Week 52: Pain Intensity Score	-2.462 T-score Standard Deviation 2.3480	-2.711 T-score Standard Deviation 2.4844	-2.847 T-score Standard Deviation 2.5377

Adverse Events

Placebo (CP)

Serious events: 5 serious events

Other events: 25 other events

Deaths: 2 deaths

Guselkumab 100 mg q8w (CP)

Serious events: 4 serious events

Other events: 38 other events

Deaths: 0 deaths

Guselkumab 100 mg q4w (CP)

Serious events: 0 serious events

Other events: 28 other events

Deaths: 0 deaths

Placebo to Guselkumab 100 mg q4w (ACP Through Week 60)

Serious events: 4 serious events

Other events: 25 other events

Deaths: 0 deaths

Guselkumab 100 mg q8w (Through Week 60)

Serious events: 8 serious events

Other events: 48 other events

Deaths: 0 deaths

Guselkumab 100 mg q4w (Through Week 60)

Serious events: 4 serious events

Other events: 41 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo (CP) n=126 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=127 participants at risk Participants received guselkumab 100 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=128 participants at risk Participants received guselkumab 100 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 (ACP Through Week 60) n=114 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 mg subcutaneous injections every 4 weeks from Week 24 through Week 48. Data from the first administration of guselkumab through Week 60 were included.	Guselkumab 100 mg q8w (Through Week 60) n=127 participants at risk Participants received guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks and placebo matched to guselkumab injections at other visits through Week 48. Data from Week 0 through Week 60 were included.	Guselkumab 100 mg q4w (Through Week 60) n=128 participants at risk Participants received guselkumab 100 mg subcutaneous injections every 4 weeks from Week 0 through Week 48. Data from Week 0 through Week 60 were included.
Cardiac disorders Arrhythmia Supraventricular	0.00% 0/126 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.79% 1/127 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/128 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/114 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.79% 1/127 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/128 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.
Cardiac disorders Atrial Fibrillation	0.00% 0/126 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/127 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/128 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.88% 1/114 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/127 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/128 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.
Cardiac disorders Cardiac Failure	0.79% 1/126 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/127 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/128 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/114 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/127 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/128 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.
Gastrointestinal disorders Mechanical Ileus	0.00% 0/126 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.79% 1/127 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/128 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/114 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.79% 1/127 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/128 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.
General disorders Pain	0.79% 1/126 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/127 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/128 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/114 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/127 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/128 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.
Infections and infestations Abscess Limb	0.79% 1/126 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/127 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/128 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/114 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/127 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/128 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.
Infections and infestations Bronchitis	0.00% 0/126 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/127 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/128 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/114 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.79% 1/127 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/128 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.
Infections and infestations Cellulitis	0.00% 0/126 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/127 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/128 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/114 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.79% 1/127 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/128 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.
Infections and infestations Pneumonia	0.79% 1/126 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/127 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/128 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/114 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/127 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/128 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.
Infections and infestations Pyelonephritis	0.00% 0/126 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/127 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/128 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.88% 1/114 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/127 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/128 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.
Infections and infestations Upper Respiratory Tract Infection	0.79% 1/126 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/127 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/128 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/114 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/127 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/128 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.
Infections and infestations Urosepsis	0.00% 0/126 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/127 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/128 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.88% 1/114 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/127 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/128 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.
Injury, poisoning and procedural complications Hand Fracture	0.00% 0/126 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/127 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/128 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/114 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.79% 1/127 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/128 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.
Injury, poisoning and procedural complications Head Injury	0.00% 0/126 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/127 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/128 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.88% 1/114 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/127 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/128 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.
Injury, poisoning and procedural complications Meniscus Injury	0.00% 0/126 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/127 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/128 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/114 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/127 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.78% 1/128 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.
Musculoskeletal and connective tissue disorders Foot Deformity	0.00% 0/126 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/127 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/128 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/114 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/127 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.78% 1/128 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.
Musculoskeletal and connective tissue disorders Lumbar Spinal Stenosis	0.00% 0/126 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/127 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/128 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/114 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.79% 1/127 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/128 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma Cell Myeloma	0.00% 0/126 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.79% 1/127 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/128 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/114 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.79% 1/127 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/128 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.
Renal and urinary disorders Renal Colic	0.00% 0/126 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/127 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/128 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/114 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.79% 1/127 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/128 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.
Reproductive system and breast disorders Breast Enlargement	0.00% 0/126 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/127 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/128 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/114 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/127 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.78% 1/128 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.
Reproductive system and breast disorders Cervical Dysplasia	0.00% 0/126 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.79% 1/127 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/128 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/114 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.79% 1/127 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/128 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	0.79% 1/126 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/127 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/128 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/114 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/127 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/128 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.
Skin and subcutaneous tissue disorders Pustular Psoriasis	0.79% 1/126 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/127 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/128 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/114 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/127 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/128 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.
Vascular disorders Venous Thrombosis Limb	0.00% 0/126 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/127 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/128 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/114 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/127 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.78% 1/128 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.

Other adverse events

Other adverse events
Measure	Placebo (CP) n=126 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=127 participants at risk Participants received guselkumab 100 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=128 participants at risk Participants received guselkumab 100 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 (ACP Through Week 60) n=114 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 mg subcutaneous injections every 4 weeks from Week 24 through Week 48. Data from the first administration of guselkumab through Week 60 were included.	Guselkumab 100 mg q8w (Through Week 60) n=127 participants at risk Participants received guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks and placebo matched to guselkumab injections at other visits through Week 48. Data from Week 0 through Week 60 were included.	Guselkumab 100 mg q4w (Through Week 60) n=128 participants at risk Participants received guselkumab 100 mg subcutaneous injections every 4 weeks from Week 0 through Week 48. Data from Week 0 through Week 60 were included.
Infections and infestations Bronchitis	0.79% 1/126 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	3.9% 5/127 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.78% 1/128 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	2.6% 3/114 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	7.1% 9/127 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	1.6% 2/128 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.
Infections and infestations Nasopharyngitis	6.3% 8/126 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	12.6% 16/127 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	5.5% 7/128 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	11.4% 13/114 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	16.5% 21/127 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	10.9% 14/128 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.
Infections and infestations Upper Respiratory Tract Infection	6.3% 8/126 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	5.5% 7/127 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	8.6% 11/128 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	7.0% 8/114 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	7.9% 10/127 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	12.5% 16/128 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.
Investigations Alanine Aminotransferase Increased	2.4% 3/126 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	6.3% 8/127 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	3.9% 5/128 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	3.5% 4/114 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	7.1% 9/127 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	7.0% 9/128 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.
Investigations Aspartate Aminotransferase Increased	2.4% 3/126 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	7.1% 9/127 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	2.3% 3/128 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	3.5% 4/114 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	8.7% 11/127 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	4.7% 6/128 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.
Musculoskeletal and connective tissue disorders Enthesopathy	4.8% 6/126 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	4.7% 6/127 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	4.7% 6/128 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	0.00% 0/114 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	5.5% 7/127 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.	6.2% 8/128 • Up to Week 60 Safety analysis set included participants who were randomized at Week 0 and received at least 1 (partial or complete) administration of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 60.

Additional Information

Head Rheumatology Clinical Development

Janssen Research & Development, LLC

Phone: 844-434-4210

Email: [email protected]

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