Efficacy and safety of risankizumab for active psoriatic arthritis: 24-week results from the randomised, double-blind, phase 3 KEEPsAKE 1 trial
Annals of Rheumatic Diseases Dec 19, 2021
Kristensen LE, Keiserman M, Papp K, et al. - In patients with active psoriatic arthritis (PsA) who have responded inadequately or are intolerant to ≥1 conventional synthetic disease-modifying antirheumatic drug (csDMARD), a significantly greater improvement of signs and symptoms of PsA can be obtained with risankizumab (a biological therapy that inhibits interleukin 23) vs placebo, and this medication has good tolerability.
A total of 964 patients with active PsA, enrolled in the KEEPsAKE 1 trial (a randomised, placebo-controlled, double-blind study), were randomised (1:1) to receive risankizumab 150 mg or placebo at weeks 0, 4 and 16.
The primary endpoint of ACR20 (≥20% improvement in American College of Rheumatology criteria) was achieved at week 24 in a significantly greater proportion of patients receiving risankizumab (57.3% vs placebo, 33.5%).
In patients with inadequate response or intolerance to ≥1 csDMARD, risankizumab 150 mg at weeks 0, 4 and 16 significantly improved the signs and symptoms of psoriatic arthritis, including joint symptoms, enthesitis and dactylitis, and skin and nail manifestations.
Similar rates of adverse events and serious adverse events were noted in the risankizumab and placebo groups.
Risankizumab showed good tolerability, with a safety profile similar to that seen in patients with psoriasis, and no new safety signals occurred.
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