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Efficacy and safety of risankizumab for active psoriatic arthritis: 24-week results from the randomized, double-blind, phase 3 KEEPsAKE 2 trial

Annals of Rheumatic Diseases Nov 26, 2021

Östör A, Van den Bosch F, Papp K, et al. - Risankizumab (an interleukin-23 inhibitor) conferred significant improvements than placebo in key disease outcomes and showed good tolerability in patients with psoriatic arthritis (PsA) who had previous inadequate response or intolerance to ≤2 biological therapies (Bio-IR) and/or ≥1 conventional synthetic disease-modifying antirheumatic drug (csDMARD-IR).

  • A phase 3 KEEPsAKE 2 trial was conducted to test risankizumab vs placebo for active PsA (n=444; median age 53 years) patients who were Bio-IR and/or csDMARD-IR; they were randomized to risankizumab (n=224) or placebo (n=220); 206 patients (46.5%) were Bio-IR.

  • The proportion of patients who achieved ≥20% improvement in American College of Rheumatology score (ACR20) at week 24 (primary endpoint) was assessed, and secondary endpoints evaluated key domains of PsA and patient-reported outcomes.

  • The achievement of the primary endpoint of ACR20 (51.3% vs 26.5%) and all secondary endpoints was seen in a significantly greater proportion of patients taking risankizumab vs placebo at week 24.

  • In risankizumab-treated and placebo-treated groups, serious adverse events occurred in 4.0% and 5.5% and serious infections in 0.9% and 2.3%, respectively.

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