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 the Phase 3, Randomized, Placebo-Controlled SOLSTICE Study.
Publication Title
Arthritis Rheumatol
Document Type
Article
Publication Date
2-11-2026
Keywords
washington; swedish
Abstract
Objective: 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 inhibitor (TNFi-IR).
Methods: In SOLSTICE (phase 3b, randomized, multicenter, double-blind, placebo-controlled study), enrolled adults with active PsA (≥3 swollen joints;≥3 tender joints; C-reactive protein ≥0.3 mg/dL) and inadequate response to one prior TNFi were randomized to guselkumab 100mg every 4 weeks (Q4W); guselkumab 100mg at Weeks 0 and 4, then Q8W; or placebo➔guselkumab Q4W at Week24. The primary endpoint was ≥20% improvement in American College of Rheumatology criteria (ACR20) at Week24. Secondary endpoints included ACR50; ACR70; Investigator's Global Assessment of psoriasis (IGA) of 0/1 with ≥2-grade improvement; ≥90% improvement in Psoriasis Area and Severity Index (PASI 90); and minimal disease activity (MDA) at Week24 and were analyzed by intention-to-treat.
Results: Analyses included 451 randomized participants (Q4W N=150; Q8W N=151; placebo N=150). At Week24, significantly greater proportions of guselkumab Q4W/Q8W-treated vs 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%, PASI 90 (49.4%/45.5% vs 12.0%), and MDA (18.8%/23.9% vs 5.4%) (all p< 0.001). Through Week24, 46.7%, 53.6%, and 48.3% of participants receiving Q4W, Q8W, and placebo, respectively, had ≥1 adverse event. One death occurred (myocardial infarction).
Conclusion: Comparable efficacy was observed with both guselkumab regimens in TNFi-IR participants with active PsA; safety findings were consistent with the known profile of guselkumab in patients with psoriatic disease.
Area of Special Interest
Orthopedics & Sports Medicine
Specialty/Research Institute
Orthopedics
Specialty/Research Institute
Rheumatology
DOI
10.1002/art.70092
