Trial Outcomes & Findings for Guselkumab in Active Psoriatic Arthritis Participants With Inadequate Response/Intolerance to One Prior Anti-TNF Alpha Agent (NCT NCT04936308)

Last Updated: 2026-02-13

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.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE3

Target enrollment

453 participants

Primary outcome timeframe

At Week 24

Results posted on

2026-02-13

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Followed by Guselkumab 100 mg Participants received placebo matched to guselkumab subcutaneous (SC) injections every 4 weeks (q4w) from Week 0 through Week 20. At Week 24, participants crossed over to receive guselkumab 100 mg SC injections q4w from Week 24 through Week 100.	Guselkumab 100 mg q8w Participants received guselkumab 100 mg SC injections at Weeks 0 and 4, then every 8 weeks (q8w) from Week 12 to Week 100 and placebo matched to guselkumab SC injections at Week 8 then q8w through Week 96 to maintain the blind.	Guselkumab 100 mg q4w Participants received guselkumab 100 mg SC injections q4w from Week 0 through Week 100.
Overall Study STARTED	150	152	151
Overall Study Full Analysis Set	150	151	150
Overall Study COMPLETED	138	144	141
Overall Study NOT COMPLETED	12	8	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Followed by Guselkumab 100 mg Participants received placebo matched to guselkumab subcutaneous (SC) injections every 4 weeks (q4w) from Week 0 through Week 20. At Week 24, participants crossed over to receive guselkumab 100 mg SC injections q4w from Week 24 through Week 100.	Guselkumab 100 mg q8w Participants received guselkumab 100 mg SC injections at Weeks 0 and 4, then every 8 weeks (q8w) from Week 12 to Week 100 and placebo matched to guselkumab SC injections at Week 8 then q8w through Week 96 to maintain the blind.	Guselkumab 100 mg q4w Participants received guselkumab 100 mg SC injections q4w from Week 0 through Week 100.
Overall Study Death	0	0	1
Overall Study Withdrawal by Subject	6	3	0
Overall Study Excluded from analysis (Enrolled and dosed at 2 sites)	0	1	1
Overall Study Completed protocol-required follow-up	1	2	2
Overall Study Discontinued study intervention and were being followed	2	2	4
Overall Study Other	3	0	2

Baseline Characteristics

Guselkumab in Active Psoriatic Arthritis Participants With Inadequate Response/Intolerance to One Prior Anti-TNF Alpha Agent

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=150 Participants Participants received placebo matched to guselkumab subcutaneous (SC) injections every 4 weeks (q4w) from Week 0 through Week 20. At Week 24, participants crossed over to receive guselkumab 100 mg sc injections every 4 weeks from Week 24 through Week 100.	Guselkumab 100 mg q8w n=151 Participants Participants received guselkumab 100 mg SC injections at Weeks 0 and 4, then every 8 weeks (q8w) from Week 12 to Week 100 and placebo matched to guselkumab SC injections at Week 8 then q8w through Week 96 to maintain the blind.	Guselkumab 100 mg q4w n=150 Participants Participants received guselkumab 100 mg subcutaneous injections every 4 weeks from Week 0 through to end of study.	Total n=451 Participants Total of all reporting groups
Age, Continuous	49.2 Years STANDARD_DEVIATION 12.59 • n=6 Participants	51.9 Years STANDARD_DEVIATION 12.91 • n=6 Participants	50.6 Years STANDARD_DEVIATION 13.29 • n=12 Participants	50.6 Years STANDARD_DEVIATION 12.95 • n=1267 Participants
Age, Customized Adults (18-64 years)	132 Participants n=6 Participants	126 Participants n=6 Participants	127 Participants n=12 Participants	385 Participants n=1267 Participants
Age, Customized From 65 to 84 years	18 Participants n=6 Participants	25 Participants n=6 Participants	23 Participants n=12 Participants	66 Participants n=1267 Participants
Sex: Female, Male Female	85 Participants n=6 Participants	77 Participants n=6 Participants	75 Participants n=12 Participants	237 Participants n=1267 Participants
Sex: Female, Male Male	65 Participants n=6 Participants	74 Participants n=6 Participants	75 Participants n=12 Participants	214 Participants n=1267 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	22 Participants n=6 Participants	18 Participants n=6 Participants	18 Participants n=12 Participants	58 Participants n=1267 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	127 Participants n=6 Participants	128 Participants n=6 Participants	132 Participants n=12 Participants	387 Participants n=1267 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=6 Participants	5 Participants n=6 Participants	0 Participants n=12 Participants	6 Participants n=1267 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=12 Participants	3 Participants n=1267 Participants
Race (NIH/OMB) Asian	1 Participants n=6 Participants	0 Participants n=6 Participants	3 Participants n=12 Participants	4 Participants n=1267 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=12 Participants	0 Participants n=1267 Participants
Race (NIH/OMB) Black or African American	4 Participants n=6 Participants	6 Participants n=6 Participants	5 Participants n=12 Participants	15 Participants n=1267 Participants
Race (NIH/OMB) White	141 Participants n=6 Participants	143 Participants n=6 Participants	141 Participants n=12 Participants	425 Participants n=1267 Participants
Race (NIH/OMB) More than one race	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=12 Participants	0 Participants n=1267 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=6 Participants	2 Participants n=6 Participants	0 Participants n=12 Participants	4 Participants n=1267 Participants
Region of Enrollment ARGENTINA	7 Participants n=6 Participants	9 Participants n=6 Participants	8 Participants n=12 Participants	24 Participants n=1267 Participants
Region of Enrollment BULGARIA	15 Participants n=6 Participants	17 Participants n=6 Participants	21 Participants n=12 Participants	53 Participants n=1267 Participants
Region of Enrollment CZECH REPUBLIC	10 Participants n=6 Participants	10 Participants n=6 Participants	7 Participants n=12 Participants	27 Participants n=1267 Participants
Region of Enrollment HUNGARY	8 Participants n=6 Participants	7 Participants n=6 Participants	9 Participants n=12 Participants	24 Participants n=1267 Participants
Region of Enrollment ISRAEL	3 Participants n=6 Participants	5 Participants n=6 Participants	2 Participants n=12 Participants	10 Participants n=1267 Participants
Region of Enrollment MALAYSIA	1 Participants n=6 Participants	0 Participants n=6 Participants	2 Participants n=12 Participants	3 Participants n=1267 Participants
Region of Enrollment POLAND	39 Participants n=6 Participants	42 Participants n=6 Participants	38 Participants n=12 Participants	119 Participants n=1267 Participants
Region of Enrollment RUSSIAN FEDERATION	10 Participants n=6 Participants	13 Participants n=6 Participants	5 Participants n=12 Participants	28 Participants n=1267 Participants
Region of Enrollment SPAIN	2 Participants n=6 Participants	1 Participants n=6 Participants	4 Participants n=12 Participants	7 Participants n=1267 Participants
Region of Enrollment TURKEY	5 Participants n=6 Participants	4 Participants n=6 Participants	4 Participants n=12 Participants	13 Participants n=1267 Participants
Region of Enrollment UKRAINE	18 Participants n=6 Participants	14 Participants n=6 Participants	18 Participants n=12 Participants	50 Participants n=1267 Participants
Region of Enrollment UNITED STATES	32 Participants n=6 Participants	29 Participants n=6 Participants	32 Participants n=12 Participants	93 Participants n=1267 Participants

PRIMARY outcome

Timeframe: At Week 24

Population: Full analysis set (FAS) included all participants who were randomized in the study and included in the analyses. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Placebo Followed by Guselkumab 100 mg n=142 Participants Participants received placebo matched to guselkumab subcutaneous (SC) injections every 4 weeks (q4w) from Week 0 through Week 20. At Week 24, participants crossed over to receive guselkumab 100 mg SC injections q4w from Week 24 through Week 100.	Guselkumab 100 mg q8w n=146 Participants Participants received guselkumab 100 mg SC injections at Weeks 0 and 4, then every 8 weeks (q8w) from Week 12 to Week 100 and placebo matched to guselkumab SC injections at Week 8 then q8w through Week 96 to maintain the blind.	Guselkumab 100 mg q4w n=138 Participants Participants received guselkumab 100 mg SC injections q4w from Week 0 through Week 100.
Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24	35.9 Percentage of participants	63.0 Percentage of participants	60.9 Percentage of participants

SECONDARY outcome

Timeframe: At Week 24

Population: Full analysis set included all participants who were randomized in the study and included in the analyses among the participants who had \>=3% BSA psoriatic involvement and an IGA score of \>=2 (mild) at baseline. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

A psoriasis IGA response was defined as an IGA score of 0 (cleared) or 1 (minimal) and greater than equal to (\>=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 Followed by Guselkumab 100 mg n=80 Participants Participants received placebo matched to guselkumab subcutaneous (SC) injections every 4 weeks (q4w) from Week 0 through Week 20. At Week 24, participants crossed over to receive guselkumab 100 mg SC injections q4w from Week 24 through Week 100.	Guselkumab 100 mg q8w n=84 Participants Participants received guselkumab 100 mg SC injections at Weeks 0 and 4, then every 8 weeks (q8w) from Week 12 to Week 100 and placebo matched to guselkumab SC injections at Week 8 then q8w through Week 96 to maintain the blind.	Guselkumab 100 mg q4w n=81 Participants Participants received guselkumab 100 mg SC injections q4w from Week 0 through Week 100.
Percentage of Participants Who Achieved a Psoriasis Response of Investigator's Global Assessment (IGA) Psoriasis Score of 0 or 1 and >=2 Grade Reduction From Baseline at Week 24 Among the Participants With >=3 Percent(%) Body Surface Area (BSA)	18.8 percentage of participants	60.7 percentage of participants	56.8 percentage of participants

SECONDARY outcome

Timeframe: At Week 24

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 Followed by Guselkumab 100 mg n=80 Participants Participants received placebo matched to guselkumab subcutaneous (SC) injections every 4 weeks (q4w) from Week 0 through Week 20. At Week 24, participants crossed over to receive guselkumab 100 mg SC injections q4w from Week 24 through Week 100.	Guselkumab 100 mg q8w n=84 Participants Participants received guselkumab 100 mg SC injections at Weeks 0 and 4, then every 8 weeks (q8w) from Week 12 to Week 100 and placebo matched to guselkumab SC injections at Week 8 then q8w through Week 96 to maintain the blind.	Guselkumab 100 mg q4w n=82 Participants Participants received guselkumab 100 mg SC injections q4w from Week 0 through Week 100.
Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline	12.5 percentage of participants	47.6 percentage of participants	54.9 percentage of participants

SECONDARY outcome

Timeframe: Baseline (pre dose Week 0) and Week 24

Population: FAS included all participants who were randomized in the study and included in the analyses.

The HAQ-DI is a 20-question instrument that assesses the degree of difficulty a participant has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living), each scored from 0 (no difficulty) to 3 (inability to perform a task in that area). Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 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 Followed by Guselkumab 100 mg n=150 Participants Participants received placebo matched to guselkumab subcutaneous (SC) injections every 4 weeks (q4w) from Week 0 through Week 20. At Week 24, participants crossed over to receive guselkumab 100 mg SC injections q4w from Week 24 through Week 100.	Guselkumab 100 mg q8w n=151 Participants Participants received guselkumab 100 mg SC injections at Weeks 0 and 4, then every 8 weeks (q8w) from Week 12 to Week 100 and placebo matched to guselkumab SC injections at Week 8 then q8w through Week 96 to maintain the blind.	Guselkumab 100 mg q4w n=150 Participants Participants received guselkumab 100 mg SC injections q4w from Week 0 through Week 100.
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 24	-0.2359 units on a scale Interval -0.32 to -0.1519	-0.3955 units on a scale Interval -0.4787 to -0.3122	-0.4159 units on a scale Interval -0.5006 to -0.3313

SECONDARY outcome

Timeframe: Baseline (pre dose Week 0) and Week 24

Population: FAS included all participants who were randomized in the study and included in the analyses. Missing data were imputed using Multiple Imputation (MI) after applying the Intercurrent Event (ICE) strategies. N (overall number of participants analyzed) included all participants with change data at Week 24 after applying the ICE Strategy and Missing Data Imputation.

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 Followed by Guselkumab 100 mg n=150 Participants Participants received placebo matched to guselkumab subcutaneous (SC) injections every 4 weeks (q4w) from Week 0 through Week 20. At Week 24, participants crossed over to receive guselkumab 100 mg SC injections q4w from Week 24 through Week 100.	Guselkumab 100 mg q8w n=151 Participants Participants received guselkumab 100 mg SC injections at Weeks 0 and 4, then every 8 weeks (q8w) from Week 12 to Week 100 and placebo matched to guselkumab SC injections at Week 8 then q8w through Week 96 to maintain the blind.	Guselkumab 100 mg q4w n=150 Participants Participants received guselkumab 100 mg SC injections q4w from Week 0 through Week 100.
Change From Baseline in 36-item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24	3.705 units on a scale Interval 2.464 to 4.946	6.986 units on a scale Interval 5.758 to 8.213	7.027 units on a scale Interval 5.772 to 8.282

SECONDARY outcome

Timeframe: Baseline (pre dose Week 0) and Week 24

Population: FAS included all participants who were randomized in the study and included in the analyses. Missing data were imputed using MI after applying the ICE strategies. N (overall number of participants analyzed) included all participants with change data at Week 24 after applying the ICE Strategy and Missing Data Imputation.

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 Followed by Guselkumab 100 mg n=150 Participants Participants received placebo matched to guselkumab subcutaneous (SC) injections every 4 weeks (q4w) from Week 0 through Week 20. At Week 24, participants crossed over to receive guselkumab 100 mg SC injections q4w from Week 24 through Week 100.	Guselkumab 100 mg q8w n=151 Participants Participants received guselkumab 100 mg SC injections at Weeks 0 and 4, then every 8 weeks (q8w) from Week 12 to Week 100 and placebo matched to guselkumab SC injections at Week 8 then q8w through Week 96 to maintain the blind.	Guselkumab 100 mg q4w n=150 Participants Participants received guselkumab 100 mg SC injections q4w from Week 0 through Week 100.
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 24	3.9 units on a scale Interval 2.5 to 5.3	7.8 units on a scale Interval 6.4 to 9.2	8.4 units on a scale Interval 7.0 to 9.9

SECONDARY outcome

Timeframe: At Week 24

Population: Full analysis set included all participants who were randomized in the study and were included in analyses. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

MDA is a measure that defines a satisfactory state of disease activity that includes 5 domains of PsA (joint symptoms, skin psoriasis, patient's perspective of pain and disease activity on arthritis and psoriasis, physical function and enthesitis). Participants were classified as achieving MDA if they fulfilled 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 Followed by Guselkumab 100 mg n=142 Participants Participants received placebo matched to guselkumab subcutaneous (SC) injections every 4 weeks (q4w) from Week 0 through Week 20. At Week 24, participants crossed over to receive guselkumab 100 mg SC injections q4w from Week 24 through Week 100.	Guselkumab 100 mg q8w n=145 Participants Participants received guselkumab 100 mg SC injections at Weeks 0 and 4, then every 8 weeks (q8w) from Week 12 to Week 100 and placebo matched to guselkumab SC injections at Week 8 then q8w through Week 96 to maintain the blind.	Guselkumab 100 mg q4w n=137 Participants Participants received guselkumab 100 mg SC injections q4w from Week 0 through Week 100.
Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Week 24	5.6 percentage of participants	24.8 percentage of participants	20.4 percentage of participants

SECONDARY outcome

Timeframe: At Week 16

Outcome measures

Outcome measures
Measure	Placebo Followed by Guselkumab 100 mg n=140 Participants Participants received placebo matched to guselkumab subcutaneous (SC) injections every 4 weeks (q4w) from Week 0 through Week 20. At Week 24, participants crossed over to receive guselkumab 100 mg SC injections q4w from Week 24 through Week 100.	Guselkumab 100 mg q8w n=146 Participants Participants received guselkumab 100 mg SC injections at Weeks 0 and 4, then every 8 weeks (q8w) from Week 12 to Week 100 and placebo matched to guselkumab SC injections at Week 8 then q8w through Week 96 to maintain the blind.	Guselkumab 100 mg q4w n=139 Participants Participants received guselkumab 100 mg SC injections q4w from Week 0 through Week 100.
Percentage of Participants Who Achieved ACR 20 Response at Week 16	30.7 percentage of participants	57.5 percentage of participants	53.2 percentage of participants

SECONDARY outcome

Timeframe: At Week 16

ACR 50 response: \>=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 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.

Outcome measures

Outcome measures
Measure	Placebo Followed by Guselkumab 100 mg n=139 Participants Participants received placebo matched to guselkumab subcutaneous (SC) injections every 4 weeks (q4w) from Week 0 through Week 20. At Week 24, participants crossed over to receive guselkumab 100 mg SC injections q4w from Week 24 through Week 100.	Guselkumab 100 mg q8w n=146 Participants Participants received guselkumab 100 mg SC injections at Weeks 0 and 4, then every 8 weeks (q8w) from Week 12 to Week 100 and placebo matched to guselkumab SC injections at Week 8 then q8w through Week 96 to maintain the blind.	Guselkumab 100 mg q4w n=140 Participants Participants received guselkumab 100 mg SC injections q4w from Week 0 through Week 100.
Percentage of Participants Who Achieved ACR 50 Response at Week 16	10.1 percentage of participants	28.8 percentage of participants	25.0 percentage of participants

SECONDARY outcome

Timeframe: At Week 24

Outcome measures

Outcome measures
Measure	Placebo Followed by Guselkumab 100 mg n=142 Participants Participants received placebo matched to guselkumab subcutaneous (SC) injections every 4 weeks (q4w) from Week 0 through Week 20. At Week 24, participants crossed over to receive guselkumab 100 mg SC injections q4w from Week 24 through Week 100.	Guselkumab 100 mg q8w n=146 Participants Participants received guselkumab 100 mg SC injections at Weeks 0 and 4, then every 8 weeks (q8w) from Week 12 to Week 100 and placebo matched to guselkumab SC injections at Week 8 then q8w through Week 96 to maintain the blind.	Guselkumab 100 mg q4w n=138 Participants Participants received guselkumab 100 mg SC injections q4w from Week 0 through Week 100.
Percentage of Participants Who Achieved ACR 50 Response at Week 24	12.7 percantage of participants	32.9 percantage of participants	33.3 percantage of participants

SECONDARY outcome

Timeframe: At Week 24

ACR 70 response: \>=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 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.

Outcome measures

Outcome measures
Measure	Placebo Followed by Guselkumab 100 mg n=141 Participants Participants received placebo matched to guselkumab subcutaneous (SC) injections every 4 weeks (q4w) from Week 0 through Week 20. At Week 24, participants crossed over to receive guselkumab 100 mg SC injections q4w from Week 24 through Week 100.	Guselkumab 100 mg q8w n=146 Participants Participants received guselkumab 100 mg SC injections at Weeks 0 and 4, then every 8 weeks (q8w) from Week 12 to Week 100 and placebo matched to guselkumab SC injections at Week 8 then q8w through Week 96 to maintain the blind.	Guselkumab 100 mg q4w n=137 Participants Participants received guselkumab 100 mg SC injections q4w from Week 0 through Week 100.
Percentage of Participants Who Achieved ACR 70 Response at Week 24	2.1 percentage of participants	17.8 percentage of participants	19.0 percentage of participants

SECONDARY outcome

Timeframe: From first administration of study drug (Week 0) up to Week 112

Outcome measures

Outcome data not reported

SECONDARY outcome

Population: Immunogenicity analysis set included all participants who received at least one (complete or partial) administration of guselkumab and who had at least 1 sample obtained after their first administration of guselkumab.

Number of participants with antibodies to guselkumab (ADA) were reported. A validated immunoassay was used to detect ADA.

Outcome measures

Outcome measures
Measure	Placebo Followed by Guselkumab 100 mg n=149 Participants Participants received placebo matched to guselkumab subcutaneous (SC) injections every 4 weeks (q4w) from Week 0 through Week 20. At Week 24, participants crossed over to receive guselkumab 100 mg SC injections q4w from Week 24 through Week 100.	Guselkumab 100 mg q8w n=149 Participants Participants received guselkumab 100 mg SC injections at Weeks 0 and 4, then every 8 weeks (q8w) from Week 12 to Week 100 and placebo matched to guselkumab SC injections at Week 8 then q8w through Week 96 to maintain the blind.	Guselkumab 100 mg q4w Participants received guselkumab 100 mg SC injections q4w from Week 0 through Week 100.
Number of Participants With Antibodies to Guselkumab	6 Participants	17 Participants	—

Adverse Events

Placebo

Serious events: 6 serious events

Other events: 18 other events

Deaths: 0 deaths

Guselkumab 100 mg q8w

Serious events: 4 serious events

Other events: 24 other events

Deaths: 0 deaths

Guselkumab 100 mg q4w

Serious events: 2 serious events

Other events: 16 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=149 participants at risk Participants received placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 24. Participants then received guselkumab 100 mg subcutaneous injections every 4 weeks from Week 24 through to end of study.	Guselkumab 100 mg q8w n=151 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 to end of study.	Guselkumab 100 mg q4w n=150 participants at risk Participants received guselkumab 100 mg subcutaneous injections every 4 weeks from Week 0 through to end of study.
Cardiac disorders Atrial Fibrillation	0.67% 1/149 • From first administration of study drug (Week 0) up to Week 24 Safety analysis set included all participants who received at least one (complete or partial) administration of any study intervention, that is , the treated population.	0.00% 0/151 • From first administration of study drug (Week 0) up to Week 24 Safety analysis set included all participants who received at least one (complete or partial) administration of any study intervention, that is , the treated population.	0.00% 0/150 • From first administration of study drug (Week 0) up to Week 24 Safety analysis set included all participants who received at least one (complete or partial) administration of any study intervention, that is , the treated population.
Cardiac disorders Myocardial Infarction	0.00% 0/149 • From first administration of study drug (Week 0) up to Week 24 Safety analysis set included all participants who received at least one (complete or partial) administration of any study intervention, that is , the treated population.	0.00% 0/151 • From first administration of study drug (Week 0) up to Week 24 Safety analysis set included all participants who received at least one (complete or partial) administration of any study intervention, that is , the treated population.	0.67% 1/150 • From first administration of study drug (Week 0) up to Week 24 Safety analysis set included all participants who received at least one (complete or partial) administration of any study intervention, that is , the treated population.
Gastrointestinal disorders Colitis	0.00% 0/149 • From first administration of study drug (Week 0) up to Week 24 Safety analysis set included all participants who received at least one (complete or partial) administration of any study intervention, that is , the treated population.	0.66% 1/151 • From first administration of study drug (Week 0) up to Week 24 Safety analysis set included all participants who received at least one (complete or partial) administration of any study intervention, that is , the treated population.	0.00% 0/150 • From first administration of study drug (Week 0) up to Week 24 Safety analysis set included all participants who received at least one (complete or partial) administration of any study intervention, that is , the treated population.
Gastrointestinal disorders Gastritis	0.67% 1/149 • From first administration of study drug (Week 0) up to Week 24 Safety analysis set included all participants who received at least one (complete or partial) administration of any study intervention, that is , the treated population.	0.00% 0/151 • From first administration of study drug (Week 0) up to Week 24 Safety analysis set included all participants who received at least one (complete or partial) administration of any study intervention, that is , the treated population.	0.00% 0/150 • From first administration of study drug (Week 0) up to Week 24 Safety analysis set included all participants who received at least one (complete or partial) administration of any study intervention, that is , the treated population.
Immune system disorders Allergy to Arthropod Sting	0.67% 1/149 • From first administration of study drug (Week 0) up to Week 24 Safety analysis set included all participants who received at least one (complete or partial) administration of any study intervention, that is , the treated population.	0.00% 0/151 • From first administration of study drug (Week 0) up to Week 24 Safety analysis set included all participants who received at least one (complete or partial) administration of any study intervention, that is , the treated population.	0.00% 0/150 • From first administration of study drug (Week 0) up to Week 24 Safety analysis set included all participants who received at least one (complete or partial) administration of any study intervention, that is , the treated population.
Infections and infestations Laryngitis	0.67% 1/149 • From first administration of study drug (Week 0) up to Week 24 Safety analysis set included all participants who received at least one (complete or partial) administration of any study intervention, that is , the treated population.	0.00% 0/151 • From first administration of study drug (Week 0) up to Week 24 Safety analysis set included all participants who received at least one (complete or partial) administration of any study intervention, that is , the treated population.	0.00% 0/150 • From first administration of study drug (Week 0) up to Week 24 Safety analysis set included all participants who received at least one (complete or partial) administration of any study intervention, that is , the treated population.
Infections and infestations Pyelonephritis	0.67% 1/149 • From first administration of study drug (Week 0) up to Week 24 Safety analysis set included all participants who received at least one (complete or partial) administration of any study intervention, that is , the treated population.	0.00% 0/151 • From first administration of study drug (Week 0) up to Week 24 Safety analysis set included all participants who received at least one (complete or partial) administration of any study intervention, that is , the treated population.	0.00% 0/150 • From first administration of study drug (Week 0) up to Week 24 Safety analysis set included all participants who received at least one (complete or partial) administration of any study intervention, that is , the treated population.
Musculoskeletal and connective tissue disorders Muscle Spasms	0.00% 0/149 • From first administration of study drug (Week 0) up to Week 24 Safety analysis set included all participants who received at least one (complete or partial) administration of any study intervention, that is , the treated population.	0.66% 1/151 • From first administration of study drug (Week 0) up to Week 24 Safety analysis set included all participants who received at least one (complete or partial) administration of any study intervention, that is , the treated population.	0.00% 0/150 • From first administration of study drug (Week 0) up to Week 24 Safety analysis set included all participants who received at least one (complete or partial) administration of any study intervention, that is , the treated population.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/149 • From first administration of study drug (Week 0) up to Week 24 Safety analysis set included all participants who received at least one (complete or partial) administration of any study intervention, that is , the treated population.	0.66% 1/151 • From first administration of study drug (Week 0) up to Week 24 Safety analysis set included all participants who received at least one (complete or partial) administration of any study intervention, that is , the treated population.	0.00% 0/150 • From first administration of study drug (Week 0) up to Week 24 Safety analysis set included all participants who received at least one (complete or partial) administration of any study intervention, that is , the treated population.
Nervous system disorders Myasthenia Gravis	0.00% 0/149 • From first administration of study drug (Week 0) up to Week 24 Safety analysis set included all participants who received at least one (complete or partial) administration of any study intervention, that is , the treated population.	0.00% 0/151 • From first administration of study drug (Week 0) up to Week 24 Safety analysis set included all participants who received at least one (complete or partial) administration of any study intervention, that is , the treated population.	0.67% 1/150 • From first administration of study drug (Week 0) up to Week 24 Safety analysis set included all participants who received at least one (complete or partial) administration of any study intervention, that is , the treated population.
Reproductive system and breast disorders Abnormal Uterine Bleeding	0.67% 1/149 • From first administration of study drug (Week 0) up to Week 24 Safety analysis set included all participants who received at least one (complete or partial) administration of any study intervention, that is , the treated population.	0.00% 0/151 • From first administration of study drug (Week 0) up to Week 24 Safety analysis set included all participants who received at least one (complete or partial) administration of any study intervention, that is , the treated population.	0.00% 0/150 • From first administration of study drug (Week 0) up to Week 24 Safety analysis set included all participants who received at least one (complete or partial) administration of any study intervention, that is , the treated population.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.00% 0/149 • From first administration of study drug (Week 0) up to Week 24 Safety analysis set included all participants who received at least one (complete or partial) administration of any study intervention, that is , the treated population.	0.66% 1/151 • From first administration of study drug (Week 0) up to Week 24 Safety analysis set included all participants who received at least one (complete or partial) administration of any study intervention, that is , the treated population.	0.00% 0/150 • From first administration of study drug (Week 0) up to Week 24 Safety analysis set included all participants who received at least one (complete or partial) administration of any study intervention, that is , the treated population.
Vascular disorders Deep Vein Thrombosis	0.00% 0/149 • From first administration of study drug (Week 0) up to Week 24 Safety analysis set included all participants who received at least one (complete or partial) administration of any study intervention, that is , the treated population.	0.66% 1/151 • From first administration of study drug (Week 0) up to Week 24 Safety analysis set included all participants who received at least one (complete or partial) administration of any study intervention, that is , the treated population.	0.00% 0/150 • From first administration of study drug (Week 0) up to Week 24 Safety analysis set included all participants who received at least one (complete or partial) administration of any study intervention, that is , the treated population.

Other adverse events

Other adverse events
Measure	Placebo n=149 participants at risk Participants received placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 24. Participants then received guselkumab 100 mg subcutaneous injections every 4 weeks from Week 24 through to end of study.	Guselkumab 100 mg q8w n=151 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 to end of study.	Guselkumab 100 mg q4w n=150 participants at risk Participants received guselkumab 100 mg subcutaneous injections every 4 weeks from Week 0 through to end of study.
Infections and infestations Covid-19	5.4% 8/149 • From first administration of study drug (Week 0) up to Week 24 Safety analysis set included all participants who received at least one (complete or partial) administration of any study intervention, that is , the treated population.	5.3% 8/151 • From first administration of study drug (Week 0) up to Week 24 Safety analysis set included all participants who received at least one (complete or partial) administration of any study intervention, that is , the treated population.	4.7% 7/150 • From first administration of study drug (Week 0) up to Week 24 Safety analysis set included all participants who received at least one (complete or partial) administration of any study intervention, that is , the treated population.
Infections and infestations Nasopharyngitis	5.4% 8/149 • From first administration of study drug (Week 0) up to Week 24 Safety analysis set included all participants who received at least one (complete or partial) administration of any study intervention, that is , the treated population.	6.0% 9/151 • From first administration of study drug (Week 0) up to Week 24 Safety analysis set included all participants who received at least one (complete or partial) administration of any study intervention, that is , the treated population.	3.3% 5/150 • From first administration of study drug (Week 0) up to Week 24 Safety analysis set included all participants who received at least one (complete or partial) administration of any study intervention, that is , the treated population.
Nervous system disorders Headache	2.0% 3/149 • From first administration of study drug (Week 0) up to Week 24 Safety analysis set included all participants who received at least one (complete or partial) administration of any study intervention, that is , the treated population.	6.0% 9/151 • From first administration of study drug (Week 0) up to Week 24 Safety analysis set included all participants who received at least one (complete or partial) administration of any study intervention, that is , the treated population.	2.7% 4/150 • From first administration of study drug (Week 0) up to Week 24 Safety analysis set included all participants who received at least one (complete or partial) administration of any study intervention, that is , the treated population.

Additional Information

Senior Medical Leader PEDIATRICS IMM

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. Expedited reviews will be arranged for abstracts, poster presentations, or other materials. If requested by the Sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
Publication restrictions are in place

Restriction type: OTHER