1. Efficacy and safety of risankizumab for active psoriatic arthritis: 24-week results from the randomised, double-blind, phase 3 KEEPsAKE 1 trial
- Author
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Kristensen, L.E., Keiserman, M., Papp, K., McCasland, L., White, D., Lu, W., Wang, Z., Soliman, A.M., Eldred, A., Barcomb, L., Behrens, Frank, and Publica
- Subjects
Psoriatic Arthritis ,Immunology ,Antibodies, Monoclonal ,General Biochemistry, Genetics and Molecular Biology ,arthritis ,Rheumatology ,biological therapy ,Humans ,Psoriasis ,Immunology and Allergy ,psoriatic - Abstract
ObjectiveTo evaluate risankizumab, a biological therapy that inhibits interleukin 23, in patients with active psoriatic arthritis (PsA) who have responded inadequately or are intolerant to ≥1 conventional synthetic disease-modifying antirheumatic drug (csDMARD).MethodsIn the randomised, placebo-controlled, double-blind KEEPsAKE 1 trial, 964 patients with active PsA were randomised (1:1) to receive risankizumab 150 mg or placebo at weeks 0, 4 and 16. The primary endpoint was the proportion of patients achieving ≥20% improvement in American College of Rheumatology criteria (ACR20) at week 24. Here, we report the results from the 24-week double-blind period; the open-label period with all patients receiving risankizumab is ongoing.ResultsAt week 24, a significantly greater proportion of patients receiving risankizumab achieved the primary endpoint of ACR20 (57.3% vs placebo, 33.5%; pConclusionsRisankizumab treatment results in significantly greater improvement of signs and symptoms of PsA compared with placebo and is well tolerated in patients with active PsA who have responded inadequately or are intolerant to ≥1 csDMARD.Trial registration numberNCT03675308.
- Published
- 2021