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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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