Maintenance of Response to Risankizumab in Patients With Psoriatic Arthritis: A 4-Year Analysis of the KEEPsAKE 1 and 2 Trials

Abstract

Introduction: Risankizumab, a humanized immunoglobulin G1 monoclonal antibody, specifically inhibits the p19 subunit of human interleukin 23 and is approved for treatment of active psoriatic arthritis (PsA) in adults. This post hoc analysis evaluated the long-term maintenance of clinical response through ~4 years of risankizumab treatment using data from 2 ongoing phase 3 trials, KEEPsAKE 1 and KEEPsAKE 2. Methods: Eligible patients had active PsA with inadequate response or intolerance to ≥1 conventional synthetic disease modifying antirheumatic drugs (KEEPsAKE 1 [NCT03675308]; KEEPsAKE 2 [NCT03671148]) and/or inadequate response or intolerance to 1–2 biologic therapies (KEEPsAKE 2 only). Patients received double-blinded risankizumab 150 mg or placebo for 24 weeks and open-label risankizumab 150 mg thereafter. This analysis includes patients who received continuous risankizumab through both treatment periods. Assessments included improvement of ≥20%/50%/70% in PsA symptoms using American College of Rheumatology criteria (ACR20/50/70), achievement of minimal disease activity (MDA), reduction of ≥90% in Psoriasis Area and Severity Index (PASI 90; in patients with ≥3% body surface area affected by psoriasis at baseline), and clinically meaningful reduction in pain (≥10 mm on a visual analog scale [VAS]). All data were reported as observed. Results: Among patients who achieved ACR20 at week 24 in KEEPsAKE 1 or KEEPsAKE 2, 70.7% and 86.4% maintained ACR20 responses at week 196. Similarly, ACR20 response was maintained to week 196 by 85.7% and 83.3% of week 52 responders in KEEPsAKE 1 and 2, respectively. Similar patterns of maintenance of response were observed for ACR50 and ACR70. Most patients also maintained MDA at week 196 from weeks 24 and 52 (Week 24: KEEPsAKE 1, 86.0%; KEEPsAKE 2, 81.3%; Week 52: KEEPsAKE 1, 81.2%; KEEPsAKE 2, 85.5%). The PASI 90 response was maintained at week 196 from weeks 24 and 52 (Week 24: KEEPsAKE 1, 88.2%; KEEPsAKE 2, 94.9%; Week 52: KEEPsAKE 1, 92.6%; KEEPsAKE 2, 97.1%). Weeks 24 and 52 responders maintained clinically meaningful reductions in pain VAS at week 196 (Week 24: KEEPsAKE 1, 90.2%; KEEPsAKE 2, 88.9%; Week 52: KEEPsAKE 1, 88.3%; KEEPsAKE 2, 90.1%), respectively. Conclusion: Risankizumab demonstrated durable long-term efficacy in patients with active PsA. A high proportion of patients receiving continuous risankizumab treatment in KEEPsAKE 1 and KEEPsAKE 2 maintained ACR20/50/70, MDA, or PASI90 responses and meaningful pain reduction through week 196.