KEEPsAKE 1 and KEEPsAKE 2: Efficacy and safety of risankizumab through Week 196 in active PsA

The phase III KEEPsAKE-1 (KS1; NCT03675308) and KEEPsAKE-2 (KS2; NCT03671148) trials evaluated the long-term efficacy and safety of risankizumab in 1,038 patients (KS1, n = 749 and KS2, n = 289) with active psoriatic arthritis (PsA) who previously had an inadequate response (IR) to ≥1 conventional synthetic disease-modifying antirheumatic drug (csDMARD) or biologic DMARD (bDMARD). Results from KS1 and KS2 196-week analyses were published by Östör et al. in Rheumatology and Therapy. 

Key data: In KS1 and KS2, 71.0% and 68.7% of patients in the risankizumab groups and 72.7% and 73.0% in the placebo/risankizumab groups, respectively, maintained ≥20% improvement in American College of Rheumatology criteria (ACR20) from Week 52 to 196. In KS1, 72.8% of patients in the risankizumab group and 72.2% in the placebo/risankizumab group maintained minimal disease activity (MDA) from Week 52 to 196, and 77.0% and 70.3% in KS2, respectively. No new safety signals were reported.

Key learning: Risankizumab demonstrated durable responses and a favorable long-term safety profile in both trials in patients with active PsA who had an IR to csDMARD or bDMARD.