Psoriatic arthritis: guselkumab safe, effective in phase 2a trial

  • Deodhar A & al.
  • Lancet
  • 2 Jun 2018

  • curated by Miriam Davis, PhD
  • Clinical Essentials
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Takeaway

  • 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.

Study design

  • 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).

Key results

  • 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.

Limitations

  • Short duration of study.
  • No active comparator.
  • No assessment of dose-response.

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