TOPLINE:

Guselkumab 100 mg, administered every 4 or 8 weeks, led to significant improvements in signs and symptoms of active psoriatic arthritis (PsA) in patients with inadequate response to only one prior TNF inhibitor and was not associated with any new safety signals.

METHODOLOGY:

• Researchers conducted a phase 3 clinical trial (SOLSTICE) to evaluate the efficacy and safety of guselkumab in 451 adult patients with active PsA (three or more swollen and tender joints and C-reactive protein levels ≥ 0.3 mg/dL) who had an inadequate response to only one prior TNF inhibitor.
• Participants were randomly assigned to receive guselkumab 100 mg every 4 weeks (n = 150), guselkumab 100 mg at weeks 0 and 4 and then every 8 weeks (n = 151), or placebo with crossover to guselkumab every 4 weeks at week 24 (n = 150).
• The mean age of the cohort ranged from 49.2 to 51.9 years, and 50%-56.7% of the participants were female.

TAKEAWAY:

• At week 24, significantly higher proportions of patients in the guselkumab every 4 weeks and every 8 weeks groups achieved at least a 20% improvement in the American College of Rheumatology response criteria (primary endpoint) than those in the placebo group (58.6% and 62.2% vs 34.8%; P < .001 for both).
• Improvements were evident as early as week 4 in the guselkumab every 4 weeks group.
• Patients receiving guselkumab every 4 and every 8 weeks also demonstrated greater improvements in skin outcomes and higher rates of achievement of minimal disease activity than those receiving placebo.
• At least one adverse event was reported by 46.7%, 53.6%, and 48.3% of patients in the guselkumab every 4 weeks, guselkumab every 8 weeks, and placebo groups, respectively; safety findings were consistent with the known profile of guselkumab in psoriatic disease.

IN PRACTICE:

“Both the [every 4 weeks] and [every 8 weeks] dosing regimens of guselkumab are efficacious in improving the signs and symptoms of active PsA through 6 months in a population of participants with either inadequate efficacy from or intolerance to one prior [TNF inhibitor],” the authors wrote.

SOURCE:

This study was led by Alexis Ogdie, MD, University of Pennsylvania School of Medicine, Philadelphia. It was published online on February 11, 2026, in Arthritis & Rheumatology.

LIMITATIONS: 

The study included only patients with inadequate response or intolerance to one prior TNF inhibitor, which limited generalizability. The current analyses were restricted to 6 months of follow-up. Additionally, the relatively high placebo response rate may have influenced the estimation of treatment effects.

DISCLOSURES:

This study was funded by Johnson & Johnson. Six authors declared being employees and shareholders of Johnson & Johnson. Some other authors reported receiving consulting, advisory board, or speaker fees; receiving honoraria, grants, or research support; or holding other ties with various pharmaceutical companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.