Trial Outcomes & Findings for A Study of Guselkumab in Participants With Active Psoriatic Arthritis (NCT NCT04882098)

NCT ID: NCT04882098

Last Updated: 2026-02-13

Results Overview

ACR 20 response: \>=20% improvement from baseline (bl) in both swollen (66 joints), tender (68 joints) joint count, \>=20% improvement from bl in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100mm, 0=no pain, 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100mm, 0=excellent, 100=poor), physician's global assessment of disease activity (VAS; 0-100mm, 0=no arthritis activity,100=extremely active arthritis), HAQ-DI (questionnaire assessing 8 functional areas; 0-3, 0=no difficulty, 3=inability to perform task in area), and CRP. Natural Disaster (ND)-site inaccessible due to COVID-19. Major Disruption (MD)-disruption involving Ukraine and neighboring countries/territories. Intercurrent event (ICE) handling: Composite-discontinue study drug not due to ND/MD, initiate/increase DMARD/oral corticosteroid, initiate prohibited PsA treatment; Hypothetical-discontinue/severe noncompliance of study drug due to ND/MD.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE3
• Target enrollment: 1054 participants
• Primary outcome timeframe: At Week 24
• Results posted on: 2026-02-13

Participant Flow

1054 participants were randomized, and all received study drug and were analyzed for safety (Safety Analysis Set). 5 Ukrainian sites were excluded from the main efficacy analysis (Modified FAS, N=1020), as they were unable to support key study operations due to the crisis in Ukraine and neighboring countries/territories beginning 2022-02-24. Results are currently reported until the primary completion date (30 December 2024). Results of remaining duration will be reported upon study completion.

Participant milestones

Measure	Group 1: Guselkumab 100 mg q8w Participants received guselkumab 100 milligram (mg) subcutaneous (SC) injection at Weeks 0 and 4, then every 8 weeks (q8w) starting from Week 12 through Week 44 and placebo matched to guselkumab SC injections q8w starting from Week 8 through Week 48 to maintain the blind. After the Week 48 database lock and subsequent full unblinding, placebo injections were no longer required. At Week 48, eligible participants had the option to enter a long-term extension (LTE) and continued to receive guselkumab 100 mg SC injection every 4 weeks (q4w) up to Week 156 and then followed up for safety until Week 168. Participants who did not enter LTE at Week 48 were followed up for safety till Week 60.	Group 2: Guselkumab 100 mg q4w Participants received guselkumab 100 mg SC injections q4w from Week 0 through Week 48. At Week 48, eligible participants had the option to enter a LTE and continued to receive guselkumab 100 mg SC injection q4w up to Week 156 and then followed up for safety until Week 168. Participants who did not enter LTE at Week 48 were followed up for safety till Week 60.	Group 3: Placebo Followed by Guselkumab Participants received placebo matched to guselkumab SC injections q4w starting from Week 0 through Week 20. Participants then crossed over and received guselkumab 100 mg SC injections q4w from Week 24 through Week 48. At Week 48, eligible participants had the option to enter a LTE and continued to receive guselkumab 100 mg SC injection q4w up to Week 156 and then followed up for safety until Week 168. Participants who did not enter LTE at Week 48 were followed up for safety till Week 60.
Overall Study STARTED	388	280	386
Overall Study Modified Full Analysis Set	371	273	376
Overall Study COMPLETED	370	270	372
Overall Study NOT COMPLETED	18	10	14

Reasons for withdrawal

Measure	Group 1: Guselkumab 100 mg q8w Participants received guselkumab 100 milligram (mg) subcutaneous (SC) injection at Weeks 0 and 4, then every 8 weeks (q8w) starting from Week 12 through Week 44 and placebo matched to guselkumab SC injections q8w starting from Week 8 through Week 48 to maintain the blind. After the Week 48 database lock and subsequent full unblinding, placebo injections were no longer required. At Week 48, eligible participants had the option to enter a long-term extension (LTE) and continued to receive guselkumab 100 mg SC injection every 4 weeks (q4w) up to Week 156 and then followed up for safety until Week 168. Participants who did not enter LTE at Week 48 were followed up for safety till Week 60.	Group 2: Guselkumab 100 mg q4w Participants received guselkumab 100 mg SC injections q4w from Week 0 through Week 48. At Week 48, eligible participants had the option to enter a LTE and continued to receive guselkumab 100 mg SC injection q4w up to Week 156 and then followed up for safety until Week 168. Participants who did not enter LTE at Week 48 were followed up for safety till Week 60.	Group 3: Placebo Followed by Guselkumab Participants received placebo matched to guselkumab SC injections q4w starting from Week 0 through Week 20. Participants then crossed over and received guselkumab 100 mg SC injections q4w from Week 24 through Week 48. At Week 48, eligible participants had the option to enter a LTE and continued to receive guselkumab 100 mg SC injection q4w up to Week 156 and then followed up for safety until Week 168. Participants who did not enter LTE at Week 48 were followed up for safety till Week 60.
Overall Study Adverse Event	7	2	1
Overall Study Death	0	1	0
Overall Study Lack of Efficacy	2	3	3
Overall Study Lost to Follow-up	0	1	0
Overall Study Withdrawal by Subject	6	1	9
Overall Study Subject refused further study treatment	1	0	0
Overall Study Other	2	2	1

Baseline Characteristics

A Study of Guselkumab in Participants With Active Psoriatic Arthritis

Baseline characteristics by cohort

Measure	Group 1: Guselkumab 100 mg q8w n=388 Participants Participants received guselkumab 100 mg SC injection at Weeks 0 and 4, then q8w starting from Week 12 through Week 44 and placebo matched to guselkumab SC injections q8w starting from Week 8 through Week 48 to maintain the blind. After the Week 48 database lock and subsequent full unblinding, placebo injections were no longer required. At Week 48, eligible participants had the option to enter a LTE and continued to receive guselkumab 100 mg SC injection every q4w up to Week 156 and then followed up for safety until Week 168. Participants who did not enter LTE at Week 48 were followed up for safety till Week 60.	Group 2: Guselkumab 100 mg q4w n=280 Participants Participants received guselkumab 100 mg SC injections q4w from Week 0 through Week 48. At Week 48, eligible participants had the option to enter a LTE and continued to receive guselkumab 100 mg SC injection q4w up to Week 156 and then followed up for safety until Week 168. Participants who did not enter LTE at Week 48 were followed up for safety till Week 60.	Group 3: Placebo Followed by Guselkumab n=386 Participants Participants received placebo matched to guselkumab SC injections q4w starting from Week 0 through Week 20. Participants then crossed over and received guselkumab 100 mg SC injections q4w from Week 24 through Week 48. At Week 48, eligible participants had the option to enter a LTE and continued to receive guselkumab 100 mg SC injection q4w up to Week 156 and then followed up for safety until Week 168. Participants who did not enter LTE at Week 48 were followed up for safety till Week 60.	Total n=1054 Participants Total of all reporting groups
Age, Continuous	52.9 years STANDARD_DEVIATION 13.03 • n=6 Participants	52.3 years STANDARD_DEVIATION 13.15 • n=6 Participants	53.4 years STANDARD_DEVIATION 12.92 • n=12 Participants	52.9 years STANDARD_DEVIATION 13.02 • n=1267 Participants
Age, Customized Adults (18-64 years)	311 Participants n=6 Participants	229 Participants n=6 Participants	304 Participants n=12 Participants	844 Participants n=1267 Participants
Age, Customized From 65 to 84 years	77 Participants n=6 Participants	51 Participants n=6 Participants	82 Participants n=12 Participants	210 Participants n=1267 Participants
Age, Customized 85 years and over	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=12 Participants	0 Participants n=1267 Participants
Sex: Female, Male Female	182 Participants n=6 Participants	127 Participants n=6 Participants	170 Participants n=12 Participants	479 Participants n=1267 Participants
Sex: Female, Male Male	206 Participants n=6 Participants	153 Participants n=6 Participants	216 Participants n=12 Participants	575 Participants n=1267 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=6 Participants	4 Participants n=6 Participants	8 Participants n=12 Participants	18 Participants n=1267 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	382 Participants n=6 Participants	276 Participants n=6 Participants	378 Participants n=12 Participants	1036 Participants n=1267 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=12 Participants	0 Participants n=1267 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=6 Participants	0 Participants n=6 Participants	2 Participants n=12 Participants	2 Participants n=1267 Participants
Race (NIH/OMB) Asian	61 Participants n=6 Participants	38 Participants n=6 Participants	61 Participants n=12 Participants	160 Participants n=1267 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=6 Participants	2 Participants n=6 Participants	0 Participants n=12 Participants	4 Participants n=1267 Participants
Race (NIH/OMB) Black or African American	2 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=12 Participants	2 Participants n=1267 Participants
Race (NIH/OMB) White	322 Participants n=6 Participants	240 Participants n=6 Participants	321 Participants n=12 Participants	883 Participants n=1267 Participants
Race (NIH/OMB) More than one race	0 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=12 Participants	1 Participants n=1267 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=12 Participants	2 Participants n=1267 Participants
Region of Enrollment Australia	3 Participants n=6 Participants	3 Participants n=6 Participants	3 Participants n=12 Participants	9 Participants n=1267 Participants
Region of Enrollment Bosnia and Herzegovina	24 Participants n=6 Participants	13 Participants n=6 Participants	25 Participants n=12 Participants	62 Participants n=1267 Participants
Region of Enrollment Bulgaria	32 Participants n=6 Participants	28 Participants n=6 Participants	35 Participants n=12 Participants	95 Participants n=1267 Participants
Region of Enrollment Canada	3 Participants n=6 Participants	1 Participants n=6 Participants	1 Participants n=12 Participants	5 Participants n=1267 Participants
Region of Enrollment China	25 Participants n=6 Participants	17 Participants n=6 Participants	27 Participants n=12 Participants	69 Participants n=1267 Participants
Region of Enrollment Croatia	8 Participants n=6 Participants	2 Participants n=6 Participants	5 Participants n=12 Participants	15 Participants n=1267 Participants
Region of Enrollment Estonia	3 Participants n=6 Participants	2 Participants n=6 Participants	5 Participants n=12 Participants	10 Participants n=1267 Participants
Region of Enrollment Georgia	37 Participants n=6 Participants	30 Participants n=6 Participants	33 Participants n=12 Participants	100 Participants n=1267 Participants
Region of Enrollment Germany	4 Participants n=6 Participants	1 Participants n=6 Participants	0 Participants n=12 Participants	5 Participants n=1267 Participants
Region of Enrollment Greece	1 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=12 Participants	2 Participants n=1267 Participants
Region of Enrollment Hungary	5 Participants n=6 Participants	10 Participants n=6 Participants	10 Participants n=12 Participants	25 Participants n=1267 Participants
Region of Enrollment Israel	6 Participants n=6 Participants	2 Participants n=6 Participants	7 Participants n=12 Participants	15 Participants n=1267 Participants
Region of Enrollment Italy	3 Participants n=6 Participants	2 Participants n=6 Participants	2 Participants n=12 Participants	7 Participants n=1267 Participants
Region of Enrollment Latvia	13 Participants n=6 Participants	4 Participants n=6 Participants	4 Participants n=12 Participants	21 Participants n=1267 Participants
Region of Enrollment Lithuania	16 Participants n=6 Participants	15 Participants n=6 Participants	23 Participants n=12 Participants	54 Participants n=1267 Participants
Region of Enrollment Malaysia	4 Participants n=6 Participants	2 Participants n=6 Participants	5 Participants n=12 Participants	11 Participants n=1267 Participants
Region of Enrollment Philippines	32 Participants n=6 Participants	18 Participants n=6 Participants	23 Participants n=12 Participants	73 Participants n=1267 Participants
Region of Enrollment Poland	38 Participants n=6 Participants	25 Participants n=6 Participants	27 Participants n=12 Participants	90 Participants n=1267 Participants
Region of Enrollment Russian Federation	20 Participants n=6 Participants	16 Participants n=6 Participants	19 Participants n=12 Participants	55 Participants n=1267 Participants
Region of Enrollment Serbia	27 Participants n=6 Participants	20 Participants n=6 Participants	28 Participants n=12 Participants	75 Participants n=1267 Participants
Region of Enrollment Slovakia	6 Participants n=6 Participants	6 Participants n=6 Participants	6 Participants n=12 Participants	18 Participants n=1267 Participants
Region of Enrollment Slovenia	1 Participants n=6 Participants	1 Participants n=6 Participants	0 Participants n=12 Participants	2 Participants n=1267 Participants
Region of Enrollment Korea, South	0 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=12 Participants	1 Participants n=1267 Participants
Region of Enrollment Spain	9 Participants n=6 Participants	9 Participants n=6 Participants	14 Participants n=12 Participants	32 Participants n=1267 Participants
Region of Enrollment Taiwan	1 Participants n=6 Participants	1 Participants n=6 Participants	3 Participants n=12 Participants	5 Participants n=1267 Participants
Region of Enrollment Turkey	1 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=12 Participants	2 Participants n=1267 Participants
Region of Enrollment Ukraine	35 Participants n=6 Participants	25 Participants n=6 Participants	39 Participants n=12 Participants	99 Participants n=1267 Participants
Region of Enrollment United States	10 Participants n=6 Participants	11 Participants n=6 Participants	13 Participants n=12 Participants	34 Participants n=1267 Participants
Region of Enrollment Czech Republic	21 Participants n=6 Participants	16 Participants n=6 Participants	26 Participants n=12 Participants	63 Participants n=1267 Participants

PRIMARY outcome

Timeframe: At Week 24

Population: Analysis population is Modified FAS (mFAS). Participants who achieved ACR 20 response at Week 24 and did not meet any Composite Strategy ICEs before Week 24 were considered as responders. Participants who met any Composite Strategy ICEs before Week 24 were considered non-responders. Participants who met Hypothetical Strategy ICEs, or missed data due to ND/MD, had affected visits imputed using multiple imputation. Other missing data were imputed as non-responders.

ACR 20 response: >=20% improvement from baseline (bl) in both swollen (66 joints), tender (68 joints) joint count, >=20% improvement from bl in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100mm, 0=no pain, 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100mm, 0=excellent, 100=poor), physician's global assessment of disease activity (VAS; 0-100mm, 0=no arthritis activity,100=extremely active arthritis), HAQ-DI (questionnaire assessing 8 functional areas; 0-3, 0=no difficulty, 3=inability to perform task in area), and CRP. Natural Disaster (ND)-site inaccessible due to COVID-19. Major Disruption (MD)-disruption involving Ukraine and neighboring countries/territories. Intercurrent event (ICE) handling: Composite-discontinue study drug not due to ND/MD, initiate/increase DMARD/oral corticosteroid, initiate prohibited PsA treatment; Hypothetical-discontinue/severe noncompliance of study drug due to ND/MD.

Outcome measures

Measure	Group 1: Guselkumab 100 mg q8w n=371 Participants Participants received guselkumab 100 mg SC injection at Weeks 0 and 4, then q8w starting from Week 12 through Week 44 and placebo matched to guselkumab SC injections q8w starting from Week 8 through Week 48 to maintain the blind. After the Week 48 database lock and subsequent full unblinding, placebo injections were no longer required. At Week 48, eligible participants had the option to enter a LTE and continued to receive guselkumab 100 mg SC injection every q4w up to Week 156 and then followed up for safety until Week 168. Participants who did not enter LTE at Week 48 were followed up for safety till Week 60.	Group 2: Guselkumab 100 mg q4w n=273 Participants Participants received guselkumab 100 mg SC injections q4w from Week 0 through Week 48. At Week 48, eligible participants had the option to enter a LTE and continued to receive guselkumab 100 mg SC injection q4w up to Week 156 and then followed up for safety until Week 168. Participants who did not enter LTE at Week 48 were followed up for safety till Week 60.	Group 3: Placebo Followed by Guselkumab n=376 Participants Participants received placebo matched to guselkumab SC injections q4w starting from Week 0 through Week 20. Participants then crossed over and received guselkumab 100 mg SC injections q4w from Week 24 through Week 48. At Week 48, eligible participants had the option to enter a LTE and continued to receive guselkumab 100 mg SC injection q4w up to Week 156 and then followed up for safety until Week 168. Participants who did not enter LTE at Week 48 were followed up for safety till Week 60.
Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24	68.3 percentage of participants	66.6 percentage of participants	47.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline (after first administration of study drug) and Week 24

Population: Modified full analysis set included all participants who were randomized, excluding participants from Ukrainian sites rendered unable to support key study operations due to major disruption. Participants who met Hypothetical Strategy ICEs had affected visits imputed using multiple imputation. Missing data were also imputed using multiple imputation.

Modified vdH-S score was sum of erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score was total erosion severity in 40 joints of 2 hands and 12 joints of 2 feet, maximum erosion score=320. Each hand joint was scored on 0 to 5 with 0 =no erosion, 5 =complete collapse of bone. Foot joint was scored on 0 to 10, 0 =no erosion, 10 =complete collapse of bone. JSN score was total JSN score in same 52 joints, each joint scored on 0 to 4 with 0 indicating no JSN, and 4 indicating absence of joint space, maximum JSN score=208. Maximum modified vdH-S score=528. Higher score =severe structural destruction and complete loss of joint spaces. Natural Disaster (ND)-site inaccessible due to COVID-19. Major Disruption (MD)-disruption involving Ukraine and neighboring countries/territories. Intercurrent event (ICE) handling: Hypothetical-discontinue/severe noncompliance of study drug due to ND/MD

Outcome measures

Measure	Group 1: Guselkumab 100 mg q8w n=371 Participants Participants received guselkumab 100 mg SC injection at Weeks 0 and 4, then q8w starting from Week 12 through Week 44 and placebo matched to guselkumab SC injections q8w starting from Week 8 through Week 48 to maintain the blind. After the Week 48 database lock and subsequent full unblinding, placebo injections were no longer required. At Week 48, eligible participants had the option to enter a LTE and continued to receive guselkumab 100 mg SC injection every q4w up to Week 156 and then followed up for safety until Week 168. Participants who did not enter LTE at Week 48 were followed up for safety till Week 60.	Group 2: Guselkumab 100 mg q4w n=273 Participants Participants received guselkumab 100 mg SC injections q4w from Week 0 through Week 48. At Week 48, eligible participants had the option to enter a LTE and continued to receive guselkumab 100 mg SC injection q4w up to Week 156 and then followed up for safety until Week 168. Participants who did not enter LTE at Week 48 were followed up for safety till Week 60.	Group 3: Placebo Followed by Guselkumab n=376 Participants Participants received placebo matched to guselkumab SC injections q4w starting from Week 0 through Week 20. Participants then crossed over and received guselkumab 100 mg SC injections q4w from Week 24 through Week 48. At Week 48, eligible participants had the option to enter a LTE and continued to receive guselkumab 100 mg SC injection q4w up to Week 156 and then followed up for safety until Week 168. Participants who did not enter LTE at Week 48 were followed up for safety till Week 60.
Change From Baseline in Psoriatic Arthritis (PsA) Modified Van Der Heijde-Sharp (vdH-S) Total Score at Week 24	0.54 Score on a scale Interval 0.14 to 0.95	0.55 Score on a scale Interval 0.1 to 1.0	1.35 Score on a scale Interval 0.94 to 1.75

SECONDARY outcome

Timeframe: From baseline (after first administration of study drug) up to 168 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From baseline (after first administration of study drug) up to 168 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From baseline (after first administration of study drug) up to 168 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From baseline (after first administration of study drug) up to 168 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From baseline (after first administration of study drug) up to 168 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From baseline (after first administration of study drug) up to 168 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From baseline (after first administration of study drug) up to 168 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From baseline (after first administration of study drug) up to 168 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From baseline (after first administration of study drug) up to 168 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From baseline (after first administration of study drug) up to 168 weeks

Outcome measures

Outcome data not reported

Adverse Events

Group 1: Guselkumab 100 mg q8w

Serious events: 12 serious events

Other events: 41 other events

Deaths: 0 deaths

Group 2: Guselkumab 100 mg q4w

Serious events: 5 serious events

Other events: 22 other events

Deaths: 1 deaths

Group 3: Placebo Followed by Guselkumab

Serious events: 10 serious events

Other events: 42 other events

Deaths: 0 deaths

Serious adverse events

Measure	Group 1: Guselkumab 100 mg q8w n=388 participants at risk Participants received guselkumab 100 mg SC injection at Weeks 0 and 4, then q8w starting from Week 12 through Week 44 and placebo matched to guselkumab SC injections q8w starting from Week 8 through Week 48 to maintain the blind. After the Week 48 database lock and subsequent full unblinding, placebo injections were no longer required. At Week 48, eligible participants had the option to enter a LTE and continued to receive guselkumab 100 mg SC injection every q4w up to Week 156 and then followed up for safety until Week 168. Participants who did not enter LTE at Week 48 were followed up for safety till Week 60.	Group 2: Guselkumab 100 mg q4w n=280 participants at risk Participants received guselkumab 100 mg SC injections q4w from Week 0 through Week 48. At Week 48, eligible participants had the option to enter a LTE and continued to receive guselkumab 100 mg SC injection q4w up to Week 156 and then followed up for safety until Week 168. Participants who did not enter LTE at Week 48 were followed up for safety till Week 60.	Group 3: Placebo Followed by Guselkumab n=386 participants at risk Participants received placebo matched to guselkumab SC injections q4w starting from Week 0 through Week 20. Participants then crossed over and received guselkumab 100 mg SC injections q4w from Week 24 through Week 48. At Week 48, eligible participants had the option to enter a LTE and continued to receive guselkumab 100 mg SC injection q4w up to Week 156 and then followed up for safety until Week 168. Participants who did not enter LTE at Week 48 were followed up for safety till Week 60.
Infections and infestations Covid-19	0.26% 1/388 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.	0.36% 1/280 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.	0.26% 1/386 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.
Hepatobiliary disorders Cholecystitis	0.26% 1/388 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.	0.00% 0/280 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.	0.00% 0/386 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.
Hepatobiliary disorders Cholelithiasis	0.00% 0/388 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.	0.00% 0/280 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.	0.26% 1/386 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.
Infections and infestations Appendicitis	0.26% 1/388 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.	0.00% 0/280 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.	0.00% 0/386 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.
Cardiac disorders Arteriosclerosis Coronary Artery	0.26% 1/388 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.	0.00% 0/280 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.	0.00% 0/386 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.
Cardiac disorders Atrial Fibrillation	0.00% 0/388 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.	0.00% 0/280 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.	0.26% 1/386 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.
Cardiac disorders Myocardial Infarction	0.26% 1/388 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.	0.00% 0/280 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.	0.00% 0/386 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.
Infections and infestations Covid-19 Pneumonia	0.26% 1/388 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.	0.00% 0/280 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.	0.00% 0/386 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.
Infections and infestations Diverticulitis	0.00% 0/388 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.	0.36% 1/280 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.	0.00% 0/386 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.
Infections and infestations Pneumonia	0.52% 2/388 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.	0.00% 0/280 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.	0.00% 0/386 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.
Injury, poisoning and procedural complications Clavicle Fracture	0.00% 0/388 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.	0.00% 0/280 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.	0.26% 1/386 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.
Injury, poisoning and procedural complications Humerus Fracture	0.00% 0/388 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.	0.00% 0/280 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.	0.26% 1/386 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.
Injury, poisoning and procedural complications Limb Injury	0.00% 0/388 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.	0.00% 0/280 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.	0.26% 1/386 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.
Injury, poisoning and procedural complications Radius Fracture	0.00% 0/388 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.	0.00% 0/280 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.	0.26% 1/386 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.
Injury, poisoning and procedural complications Tendon Rupture	0.00% 0/388 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.	0.36% 1/280 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.	0.00% 0/386 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.
Metabolism and nutrition disorders Obesity	0.00% 0/388 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.	0.00% 0/280 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.	0.26% 1/386 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.26% 1/388 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.	0.00% 0/280 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.	0.00% 0/386 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.
Musculoskeletal and connective tissue disorders Psoriatic Arthropathy	0.26% 1/388 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.	0.00% 0/280 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.	0.00% 0/386 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholesteatoma	0.26% 1/388 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.	0.00% 0/280 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.	0.00% 0/386 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian Adenoma	0.00% 0/388 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.	0.00% 0/280 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.	0.26% 1/386 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer	0.26% 1/388 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.	0.00% 0/280 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.	0.00% 0/386 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal Cancer	0.26% 1/388 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.	0.00% 0/280 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.	0.00% 0/386 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.
Nervous system disorders Vertebrobasilar Insufficiency	0.00% 0/388 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.	0.00% 0/280 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.	0.26% 1/386 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.
Renal and urinary disorders Acute Kidney Injury	0.26% 1/388 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.	0.00% 0/280 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.	0.00% 0/386 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.
Renal and urinary disorders Renal Colic	0.00% 0/388 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.	0.00% 0/280 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.	0.26% 1/386 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.
Reproductive system and breast disorders Endometriosis	0.00% 0/388 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.	0.36% 1/280 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.	0.00% 0/386 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	0.26% 1/388 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.	0.00% 0/280 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.	0.00% 0/386 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.26% 1/388 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.	0.36% 1/280 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.	0.00% 0/386 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.
Vascular disorders Superficial Vein Thrombosis	0.00% 0/388 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.	0.00% 0/280 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.	0.26% 1/386 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.

Other adverse events

Measure	Group 1: Guselkumab 100 mg q8w n=388 participants at risk Participants received guselkumab 100 mg SC injection at Weeks 0 and 4, then q8w starting from Week 12 through Week 44 and placebo matched to guselkumab SC injections q8w starting from Week 8 through Week 48 to maintain the blind. After the Week 48 database lock and subsequent full unblinding, placebo injections were no longer required. At Week 48, eligible participants had the option to enter a LTE and continued to receive guselkumab 100 mg SC injection every q4w up to Week 156 and then followed up for safety until Week 168. Participants who did not enter LTE at Week 48 were followed up for safety till Week 60.	Group 2: Guselkumab 100 mg q4w n=280 participants at risk Participants received guselkumab 100 mg SC injections q4w from Week 0 through Week 48. At Week 48, eligible participants had the option to enter a LTE and continued to receive guselkumab 100 mg SC injection q4w up to Week 156 and then followed up for safety until Week 168. Participants who did not enter LTE at Week 48 were followed up for safety till Week 60.	Group 3: Placebo Followed by Guselkumab n=386 participants at risk Participants received placebo matched to guselkumab SC injections q4w starting from Week 0 through Week 20. Participants then crossed over and received guselkumab 100 mg SC injections q4w from Week 24 through Week 48. At Week 48, eligible participants had the option to enter a LTE and continued to receive guselkumab 100 mg SC injection q4w up to Week 156 and then followed up for safety until Week 168. Participants who did not enter LTE at Week 48 were followed up for safety till Week 60.
Infections and infestations Covid-19	5.7% 22/388 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.	2.9% 8/280 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.	5.2% 20/386 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.
Infections and infestations Upper Respiratory Tract Infection	5.2% 20/388 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.	5.4% 15/280 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.	5.7% 22/386 • All cause mortality, SAEs, and non-SAEs: From baseline (after first administration of study drug) up to 24 weeks. Safety analysis set included all participants who received at least one (complete or partial) administration of study intervention, that is, the treated population.

Additional Information

Executive Medical Director

Janssen Research and Development, LLC

Phone: 844-434-4210

Email: ClinicalTrialDisclosure@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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 in writing, such publication will be withheld for up to an additional 60 days.
• Publication restrictions are in place

Restriction type: OTHER