- Guselkumab was found safe and effective vs placebo for patients with active psoriatic arthritis in a phase 2a clinical trial.
Why this matters
- New treatment option for difficult-to-treat condition, if future phase 3 trials show favorable results.
- Randomized, double-blind, placebo-controlled, multicenter trial of 149 patients with active psoriatic arthritis and plaque psoriasis affecting at least 3% of their body surface area, with 3 or more of 66 tender joints and 3 or more of 68 swollen joints, and with inadequate response or intolerance to standard treatments.
- Subcutaneous guselkumab 100 mg or placebo were administered at weeks 0 and 4 and every 8 weeks thereafter until 24 weeks.
- Primary outcome was percentage of patients with ≥20% improvement at week 24 on the American College of Rheumatology criteria (ACR20).
- The guselkumab group had a higher rate of ACR20 response (58%) than placebo (18%; percentage difference, 39.7%; P<.0001>
- No difference between groups in at least 1 adverse event (36% of guselkumab-treated vs 33% of placebo-treated patients).
- Infection was the most frequent adverse event in both groups (16% vs 20%, respectively).
- No deaths were observed.
- Short duration of study.
- No active comparator.
- No assessment of dose-response.