Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis: 196-Week Results from the KEEPsAKE 1 and KEEPsAKE 2 Randomized Clinical Trials

The ongoing KEEPsAKE 1 and 2 (KS1; KS2) trials evaluate the efficacy and safety of risankizumab in patients with psoriatic arthritis (PsA) who had an inadequate response to ≥ 1 conventional synthetic disease-modifying antirheumatic drug(s) (csDMARD-IR, KS1&2) and/or 1–2 biologic DMARDs (bDMARD-IR, KS2). Herein, we present week 196 efficacy and safety findings from KS1 and KS2. Patients were randomized 1:1 in a double-blind fashion to receive subcutaneous risankizumab 150 mg or placebo (weeks 0, 4, 16, and 24). All patients received open-label risankizumab at week 28 and every 12 weeks thereafter (i.e., continuous risankizumab, placebo/risankizumab). Assessments included ≥ 20%/50%/70% improvement in PsA symptoms using American College of Rheumatology criteria (ACR20/50/70) and achievement of minimal disease activity (MDA). At week 196, 749 patients remained in KS1 and 289 in KS2. In KS1, 57.1% of patients receiving continuous risankizumab and 56.5% receiving placebo/risankizumab achieved ACR20, while 54.5% receiving continuous risankizumab and 50.2% receiving placebo/risankizumab achieved ACR20 in KS2 at week 196. Maintenance of ACR20 achievement in KS1 from week 52 to week 196 was observed for 71.0% of patients receiving continuous risankizumab and 72.7% receiving placebo/risankizumab. The same was observed in KS2 for 68.7% of patients receiving continuous risankizumab and 73.0% receiving placebo/risankizumab. The proportion of patients achieving MDA was 39.6% receiving continuous risankizumab and 35.2% receiving placebo/risankizumab in KS1, while 35.3% of patients receiving continuous risankizumab and 37.4% receiving placebo/risankizumab achieved MDA in KS2 at week 196. In KS1, maintenance of MDA at week 196 from week 52 was achieved by 72.8% of patients receiving continuous risankizumab and 72.2% receiving placebo/risankizumab. In KS2, 77.0% of patients receiving continuous risankizumab and 70.3% receiving placebo/risankizumab achieved the same. No new safety signals were reported. Risankizumab demonstrated durable efficacy and safety at week 196 in KS1 and KS2. KS1: ClinicalTrials.gov, NCT03675308; KS2: ClinicalTrials.gov, NCT03671148. Psoriatic arthritis (PsA) is a chronic, relapsing, inflammatory musculoskeletal disease that commonly occurs in the presence of psoriasis. Due to PsA’s chronicity, durable treatments are necessary to help patients with PsA attain minimal disease activity (MDA). The ongoing KEEPsAKE 1 and 2 (KS1; KS2) trials are evaluating the efficacy and safety of risankizumab in patients with PsA who were unsuccessfully treated with one or more conventional synthetic disease-modifying antirheumatic drug(s) (csDMARD; KS1&2) and/or one or two biologic DMARDs (bDMARD; KS2). Patients were randomly assigned to receive continuous subcutaneous risankizumab 150 mg or a placebo for 24 weeks. At week 28, all patients received risankizumab 150 mg for the remainder of the trials. In both trials, most patients who achieved ≥ 20% reduction in American College of Rheumatology criteria for symptoms of rheumatoid arthritis (ACR20) and MDA (meeting ≥ 5/7 criteria of low disease activity) at week 52 maintained their response at week 196. At week 196, 57.1% of patients receiving continuous risankizumab and 56.5% receiving placebo/risankizumab achieved ACR20 in KS1. In KS2, 54.5% of patients receiving continuous risankizumab and 50.2% receiving placebo/risankizumab achieved ACR20 at week 196. The proportion of patients achieving MDA was 39.6% receiving continuous risankizumab, and 35.2% receiving placebo/risankizumab in KS1, while 35.3% of patients receiving continuous risankizumab and 37.4% receiving placebo/risankizumab achieved MDA in KS2 at week 196. Improvements were seen in several other measures in both trials and no new safety signals were reported.

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