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.
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.