Phase 2 Completed N=149 Randomized Double-blind Treatment

Efficacy and Safety Study of Guselkumab in the Treatment of Participants With Active Psoriatic Arthritis (PsA)

Rheumatoid Arthritis

Source: ClinicalTrials.gov NCT02319759 ↗

Enrolled (actual)

149

Serious AEs

3.4%

Results posted

Oct 2020

Primary outcomePrimary: Percentage of Participants Who Achieved American College of Rheumatology (ACR) 20 Response at Week 24 — 18.4; 58.0 percentage of participants — p=<0.001

Summary

The purpose of this study is to evaluate the efficacy, safety and tolerability of guselkumab in participants with Active Psoriatic Arthritis (PsA).

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants Who Achieved American College of Rheumatology (ACR) 20 Response at Week 24	18.4; 58.0	<0.001 sig
SECONDARY Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI)-75 Response at Week 24	12.5; 78.6	<0.001 sig
SECONDARY Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24	-0.06; -0.42	<0.001 sig
SECONDARY Percentage of Participants Who Achieved an ACR 20 Response at Week 16	16.3; 60.0	—
SECONDARY Percentage of Participants Who an Achieved ACR 50 Response at Week 24	10.2; 34.0	—
SECONDARY Percent Change From Baseline in Leeds Enthesitis Index (LEI) Scores Among Participants With Enthesitis at Week 24	-33.33; -100.00	—
SECONDARY Percent Change From Baseline in Dactylitis Scores Among Participants With Dactylitis at Baseline at Week 24	-33.33; -100.00	—
SECONDARY Percentage of Participants Who Achieved ACR 20, ACR 50, and ACR 70 Responses at Weeks 4, 8, 12, 16, 20, and 24	0; 21.0; 0; 1.0; 0; 0	—
SECONDARY Percentage of Participants Who Achieved ACR 20, ACR 50, and ACR 70 Responses at Weeks 24, 28, 32, 36, 44, and 56	31.0; 66.3; 17.2; 39.5; 3.4; 16.3	—
SECONDARY Percent Change From Baseline in the ACR Components at Weeks 12 and 24	-29.41; -64.50; -13.33; -45.80; 1.79; -22.05	—
SECONDARY Percent Change From Baseline in the ACR Components at Weeks 24, 28, 32, 36, 44 and 56	-33.33; -85.71; -69.05; -93.75; -84.91; -100.00	—
SECONDARY Change From Baseline in HAQ-DI Response at Weeks 4, 8, 12, 16, 20, and 24	-0.02; -0.17; -0.07; -0.32; -0.05; -0.33	—
SECONDARY Change From Baseline in HAQ-DI Score at Weeks 24, 28, 32, 36, 44, and 56	-0.19; -0.46; -0.40; -0.51; -0.50; -0.56	—
SECONDARY Percentage of Participants Who Achieved a HAQ-DI Response With Greater Than or Equal to (>=) 0.3 Improvement From Baseline in HAQ-DI Score at Weeks 4, 8, 12, 16, 20, and 24	12.2; 29.0; 26.5; 43.0; 22.4; 47.0	—
SECONDARY Percentage of Participants Who Achieved an HAQ-DI Response With >= -0.3 Improvement From Baseline in HAQ-DI Score at Weeks 24, 28, 32, 36, 44, and 56	44.8; 55.8; 53.6; 60.0; 57.1; 56.0	—
SECONDARY Percent Change From Baseline in Dactylitis Scores at Weeks 4, 8, 16, and 24	-33.33; -32.46; -50.00; -75.00; -50.00; -100.00	—
SECONDARY Percent Change From Baseline in Dactylitis Scores at Weeks 24, 28, 32, 44, 56	-45.00; -100.00; -70.83; -100.00; -100.00; -100.00	—
SECONDARY Percentage of Participants With Dactylitis at Weeks 4, 8, 16, and 24	91.3; 72.4; 69.6; 56.9; 78.3; 48.3	—
SECONDARY Percentage of Participants With Dactylitis at Weeks 24, 28, 32, 44, and 56	81.3; 40.0; 62.5; 38.8; 31.3; 36.7	—
SECONDARY Percent Change From Baseline in LEI Scores at Week 4, 8, 16, and 24	0.00; -18.33; 0.00; -58.33; 0.00; -50.04	—
SECONDARY Percent Change From Baseline in LEI Scores at Weeks 24, 28, 32, 44, and 56	-50.00; -100.00; -60.00; -100.00; -100.00; -100.00	—
SECONDARY Percentage of Participants With Enthesitis Based on LEI Score at Weeks 4, 8, 16, and 24 in Participants With Enthesitis at Baseline	87.1; 76.3; 87.1; 59.2; 83.9; 53.9	—
SECONDARY Percentage of Participants With Enthesitis Based on LEI at Weeks 24, 28, 32, 44, and 56 in Participants With Enthesitis at Baseline	66.7; 38.8; 64.7; 44.8; 35.3; 31.8	—
SECONDARY Change From Baseline in Psoriatic ArthritiS Disease Activity Score (PASDAS) Score at Weeks 16 and 24	-0.45; -2.24; -0.49; -2.50	—
SECONDARY Change From Baseline in PASDAS Score at Weeks 24 and 44	-1.05; -2.80; -3.17; -3.15	—
SECONDARY Change From Baseline in GRAppa Composite scorE (GRACE) Index Score at Weeks 16 and 24	-0.29; -2.49; -0.35; -2.73	—
SECONDARY Change From Baseline in GRACE Index Score at Weeks 24 and 44	-0.91; -2.96; -3.21; -3.26	—
SECONDARY Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Weeks 16 and 24	-0.5; -3.1; -0.8; -3.9	—
SECONDARY Change From Baseline in mCPDAI Index Score at Weeks 24 and 44	-1.4; -4.3; -4.2; -4.8	—
SECONDARY Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 4, 8, 12, 16, 20 and 24	-5.62; -10.03; -8.25; -16.65; -6.84; -18.84	—
SECONDARY Change From Baseline in DAPSA Index Score at Weeks 24, 28, 32, 36, 44, and 56	-12.99; -26.93; -20.85; -29.71; -26.12; -30.59	—
SECONDARY Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 16 and 24	0; 18.0; 2.0; 23.0	—
SECONDARY Percentage of Participants Who Achieved MDA at Weeks 24 and 44	3.4; 26.7; 28.6; 34.5	—
SECONDARY Change From Baseline in the Physical and Mental Component Summary (PCS and MCS) Scores of 36- Item Short Form Health Assessment Questionnaire (SF-36) at Weeks 16 and 24	-0.44; 5.86; 0.46; 6.59; 1.14; 4.80	—
SECONDARY Change From Baseline in the PCS Scores of SF-36 at Weeks 24 and 44	2.13; 7.40; 8.02; 8.34	—
SECONDARY Change From Baseline in the MCS Scores of SF-36 at Weeks 24 and 44	0.51; 5.45; 5.53; 4.56	—
SECONDARY Change From Baseline in Norm-based SF-36 Scales at Week 16 and 24	-0.31; 6.30; -0.04; 6.93; -0.23; 4.22	—
SECONDARY Change From Baseline in Norm-based SF-36 Scale at Week 24 and 44	1.09; 7.54; 8.41; 8.50; 1.92; 5.74	—
SECONDARY Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Score at Weeks 16 and 24	-0.19; -5.41; -0.57; -5.81	—
SECONDARY Change From Baseline in RAPID3 Score at Weeks 24 and 44	-2.28; -6.36; -7.60; -7.48	—
SECONDARY Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 16 and 24	27.1; 81.6; 8.3; 71.4; 6.3; 53.1	—
SECONDARY Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 24, 28, 32, 44, and 56	37.9; 89.5; 20.7; 82.6; 10.3; 70.9	—
SECONDARY Percent Change From Baseline in PASI Score at Weeks 4, 8, 16, and 24	0.00; -41.49; 1.58; -66.67; -1.10; -90.55	—
SECONDARY Percent Change From Baseline in PASI Score at Weeks 24, 28, 32, 44, and 56	-34.26; -97.85; -57.69; -100.00; -90.61; -100.00	—

Eligibility Criteria

Inclusion Criteria

Has had Psoriatic Arthritis (PsA) for at least 6 months before the first administration of study drug and meet classification criteria for Psoriatic Arthritis (CASPAR) at Screening
Had active PsA as defined by:
At least 3 swollen joints and at least 3 tender joints at Screening and at baseline
C-reactive protein (CRP) greater than or equal to (>=) 0.3 milligram (mg)/deciliter (dL) at Screening from the central laboratory
Has at least 1 of the PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis
Has plaque psoriasis with body surface area (BSA) involvement greater than or equal to (>=) 3% at Screening and baseline
Has active PsA despite current or previous non-biologic disease-modifying antirheumatic drugs (DMARD), oral corticosteroid, and/or nonsteroidal anti-inflammatory drug (NSAID) therapy
If using methotrexate (MTX), oral corticosteroids or NSAIDs, the dose must be stable

Exclusion Criteria

Have other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy, including but not limited to rheumatoid arthritis (RA), ankylosing spondylitis (AS), systemic lupus erythematosus, or Lyme disease
Has previously received guselkumab or ustekinumab
Has received more than 1 type of biologic anti-tumor necrosis factor (TNF) agent previously
Have received infliximab (or its biosimilars) or golimumab intraveneous (IV) within 12 weeks before the first administration of study drug
Have received adalimumab (or its biosimilars), golimumab subcutaneous (SC), certolizumab pegol or etanercept (or its biosimilars) within 8 weeks before the first administration of study drug

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02319759). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.