Kristensen, Lars ErikLars ErikKristensenKeiserman, Mauro WaldemarMauro WaldemarKeisermanPapp, Kim A.Kim A.PappMcCasland, Leslie D.Leslie D.McCaslandWhite, Douglas H.N.Douglas H.N.WhiteLu, WenjingWenjingLuSoliman, Ahmed M.Ahmed M.SolimanEldred, Ann K.Ann K.EldredBarcomb, Lisa M.Lisa M.BarcombBehrens, FrankFrankBehrens2023-10-232023-10-232023https://publica.fraunhofer.de/handle/publica/45206610.1093/rheumatology/keac6072-s2.0-8516076099536282530Objective: PsA is a chronic disease with heterogeneous clinical manifestations requiring treatment options with long-term efficacy and safety. 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 more conventional synthetic DMARDs (csDMARD-IR) were evaluated. Methods: KEEPsAKE 1 is an ongoing, global, phase 3 study with a 24-week, double-blind, placebo-controlled period (period 1) and an open-label extension period (period 2). In period 1, eligible patients were randomized 1:1 to receive subcutaneous risankizumab 150 mg or placebo at weeks 0, 4 and 16. At week 24 (period 2), all continuing patients received open-label risankizumab 150 mg every 12 weeks through week 208. Results: At week 24, 57.3% of risankizumab-treated patients (n = 483) achieved ≥20% improvement in ACR criteria (ACR20) vs 33.5% of placebo-treated patients (n = 481; P < 0.001). At week 52, 70.0% of patients who were randomized to receive continuous risankizumab therapy and 63.0% of patients who were randomized to receive placebo in period 1 and then receive risankizumab at week 24 achieved ACR20. Similar result trends were observed for other efficacy measures. Risankizumab was well tolerated through 52 weeks of treatment with a consistent safety profile from week 24 through week 52. Conclusion: In patients with active PsA who were csDMARD-IR, continuous risankizumab treatment demonstrated robust long-term efficacy and was well tolerated through 52 weeks of treatment. Trial registration: ClinicalTrials.gov, http://clinicaltrials.gov, KEEPsAKE1, NCT03675308.enbiologic agentDMARDIL-23PsArisankizumabjournal article