Logo image
Back
Efficacy and Safety of Guselkumab in Participants With Active Psoriatic Arthritis After Inadequate Response to One Prior Tumor Necrosis Factor Inhibitor: Week-24 Results of a Phase 3, Randomized, Placebo-Controlled Study
Journal article   Open access   Peer reviewed

Efficacy and Safety of Guselkumab in Participants With Active Psoriatic Arthritis After Inadequate Response to One Prior Tumor Necrosis Factor Inhibitor: Week-24 Results of a Phase 3, Randomized, Placebo-Controlled Study

Alexis Ogdie, Joseph F. Merola, Philip J. Mease, Christopher T. Ritchlin, Jose U. Scher, Kimberly Parnell Lafferty, Daphne Chan, Soumya D. Chakravarty, Wayne Langholff, Yanli Wang, …
Arthritis & rheumatology (Hoboken, N.J.)
16 Apr 2026
DOI: https://doi.org/10.1002/art.70092
PMID: 41670439
url
https://doi.org/10.1002/art.70092View
Published, Version of Record (VoR) Open CC BY-NC V4.0

Abstract

Objective To evaluate the efficacy and safety of guselkumab, an interleukin-23p19 subunit inhibitor, in participants with active psoriatic arthritis (PsA) and inadequate response (inadequate efficacy and/or intolerance) to one prior tumor necrosis factor (TNF) inhibitor. Methods In SOLSTICE (phase 3b, randomized, multicenter, double-blind, placebo-controlled study), enrolled adults with active PsA (three or more swollen joints; three or more tender joints; C-reactive protein ≥ 0.3 mg/dL) and inadequate response to one prior TNF inhibitor were randomized to guselkumab 100 mg every 4 weeks (Q4W), guselkumab 100 mg at weeks 0 and 4 and then Q8W, or placebo with crossover to guselkumab Q4W at week 24. The primary endpoint was ≥20% improvement in American College of Rheumatology criteria (ACR20) at week 24. Secondary endpoints included ACR50, ACR70, Investigator's Global Assessment of psoriasis (IGA) score of 0 or 1 with ≥2-grade improvement, ≥90% improvement in Psoriasis Area and Severity Index (PASI90), and minimal disease activity (MDA) at week 24 and were analyzed by intention-to-treat. Results Analyses included 451 randomized participants (Q4W n = 150; Q8W n = 151; placebo n = 150). At week 24, significantly greater proportions of guselkumab (Q4W/Q8W)-treated participants versus placebo-treated participants, respectively, achieved ACR20 (primary endpoint: 58.6%/62.2% vs 34.8%), ACR50 (31.4%/32.1% vs 12.2%), ACR70 (17.5%/17.3% vs 2.0%), IGA 0/1 response (50.0%/57.3% vs 17.4%), PASI90 (49.4%/45.5% vs 12.0%), and MDA (18.8%/23.9% vs 5.4%) (all P < 0.001). Through week 24, 46.7%, 53.6%, and 48.3% of participants receiving guselkumab Q4W, guselkumab Q8W, and placebo, respectively, had one or more adverse event. One death occurred (myocardial infarction). Conclusion Comparable efficacy was observed with both guselkumab regimens in participants with active PsA and inadequate response to one prior TNF inhibitor; safety findings were consistent with the known profile of guselkumab in patients with psoriatic disease.

Metrics

1 Record Views

Details

Logo image