Treatment with risankizumab leads to significantly greater improvements in signs and symptoms than placebo in patients with active psoriatic arthritis (PsA) who have shown inadequate response or intolerance to 1 or 2 biologic therapies or at least one DMARD therapy. In addition, no specific safety issues were observed at 24 weeks in the phase 3 randomised, double-blind KEEPsAKE 2 trial.
Risankizumab is a humanised, monoclonal antibody targeting IL-23. In this trial, patients with active PsA and an inadequate response to biologics or conventional synthetic DMARDs (n=444) were randomised to the risankizumab (150 mg at week 0 and 4, then q12w) or placebo arm. A double-blind period of 24 weeks is followed by an open-label extension period. Prof. Andrew Östör (Monash University, Australia) presented the week 24 results of KEEPsAKE 2 (NCT03671148).
The primary endpoint was a ≥20% improvement on ACR20 response at week 24. The primary endpoint was met. Significantly more patients in the risankizumab arm (53%) had an improvement in ACR20 score than patients in the placebo arm (26.5%). Furthermore, all ranked secondary endpoints were met: change in Health Assessment Questionnaire Disability Index (HAQ-DI; risankizumab -0.22 vs placebo -0.05), Psoriasis Area and Severity Index 90 (PASI 90; risankizumab 55.0% vs placebo 10.2%), ACR20 at week 16 (risankizumab 48.3% vs placebo 25.3%), minimal disease activity (risankizumab 25.6% vs placebo 11.4%), change in SF-36 PCS (risankizumab 5.9 vs placebo 2.0), and change in FACIT-Fatigue (risankizumab 4.9 vs placebo 2.6).
Risankizumab was well tolerated and the safety profile was similar to that of risankizumab treatment in moderate-to-severe psoriasis. Other than upper respiratory tract infections, no treatment-emergent AE was observed in ≥5% of the patients in either arm of the study.
Source:
Östör A, et al. Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis, Including Patients With Inadequate Response or Intolerance to Biologic Therapies: 24-Week Results From the Phase 3, Randomized, Double-blind, KEEPsAKE 2 Trial. OP0228, EULAR 2021 Virtual Congress, 2-5 June.