Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis: 100-Week Results from the KEEPsAKE2 Randomized Clinical Trial.

Abstract

Long-term therapeutic options providing durable response and tolerability are needed for psoriatic arthritis (PsA). The ongoing KEEPsAKE2 trial is evaluating risankizumab treatment in patients with active PsA who previously had inadequate response/intolerance to ≥ 1 conventional synthetic disease-modifying antirheumatic drug (csDMARD-IR) and/or 1-2 biologic DMARDs (bDMARD-IR). Herein, we report results through 100weeks of treatment. KEEPsAKE2 is a global phase3 trial. Patients with active PsA were randomized 1:1 to double-blind subcutaneous risankizumab 150mg or placebo (weeks0, 4, and 16). At week24, all patients received open-label risankizumab every 12weeks until end of study. Efficacy endpoints included achieving ≥ 20% improvement in PsA symptoms using American College of Rheumatology criteria (ACR20), attaining minimal disease activity (MDA; meeting ≥ 5/7 criteria of low disease activity and extent), and improving in other measures. At the cutoff date, 345/443 (77.9%) patients were ongoing in thestudy. ACR20 was achieved in 57.1% and 52.5% of the continuous risankizumab and placebo/risankizumab cohorts, respectively, at week100 and in 60.0% and 55.8%, respectively, at week52. In week52 responders, maintenance of ACR20 at week100 was achieved in 74.8% (continuous risankizumab) and 78.7% (placebo/risankizumab) of patients. In the continuous risankizumab and placebo/risankizumab cohorts, respectively, MDA was achieved by 33.0% and 33.3% of patients at week100 and by 27.2% and 33.8% at week52. Among MDA responders at week52, maintenance of MDA response was achieved by 83.6% and 73.0% of the continuous risankizumab and placebo/risankizumab cohorts, respectively. Risankizumab was well tolerated through week100. Risankizumab demonstrated durable efficacy and tolerability through 100weeks; most patients who achieved ACR20 and MDA responses at week52 maintained this achievement through week100. There were no new safety signals in patients who had csDMARD-IR and bDMARD-IR. ClinicalTrials.gov NCT03671148.