Efficacy and safety of risankizumab for active psoriatic arthritis: 52-week results from the KEEPsAKE 2 study

Rheumatology (Oxford). 2022 Oct 25;keac605. doi: 10.1093/rheumatology/keac605. Online ahead of print.


Objective: Psoriatic arthritis (PsA) is a chronic inflammatory disease in which the skin and joints are affected. In this follow-up analysis, the 52-week efficacy and safety of risankizumab 150 mg in patients with active PsA who had previous inadequate response/intolerance to one or two biologic therapies (Bio-IR) or one or more conventional synthetic disease-modifying antirheumatic drug (csDMARD-IR) were evaluated.

Methods: In the ongoing, phase 3, KEEPsAKE 2 trial, patients with active PsA were randomized 1:1 to receive subcutaneous risankizumab 150 mg or placebo at weeks 0, 4 and 16 (period 1). At week 24 (period 2), patients who received placebo were switched to risankizumab, and all patients received risankizumab 150 mg every 12 weeks from weeks 28-208.

Results: At week 24, 51.3% of risankizumab-treated patients (N = 224) achieved ≥20% improvement in American College of Rheumatology criteria (ACR20) vs 26.5% of placebo-treated patients (N = 220; P < 0.001). At week 52, 58.5% of patients randomized to receive continuous risankizumab achieved ACR20, and 55.7% of patients who switched from placebo to risankizumab at week 24 achieved ACR20. Similar trends were observed for other efficacy measures. Rates of serious treatment-emergent adverse events (TEAEs) and TEAEs leading to discontinuation remained stable through week 52, and no deaths were reported.

Conclusion: Risankizumab was well tolerated and improved symptoms of PsA in Bio-IR/csDMARD-IR patients, with a consistent long-term safety profile from weeks 24-52.

Trial registration: United States National Library of Medicine clinical trials database www.clinicaltrials.gov; KEEPsAKE 2; NCT03671148.

Keywords: biologic agent; disease-modifying antirheumatic drug; interleukin 23; psoriatic arthritis; risankizumab.

Associated data

  • ClinicalTrials.gov/NCT03671148