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Risankizumab meets primary and ranked secondary endpoints in PsA

Presented by
Prof. Andrew Östör, Monash University, Australia
EULAR 2021
Phase 3, KEEPsAKE 2
Treatment with risankizumab led to significantly greater improvements in signs and symptoms than placebo in patients with active psoriatic arthritis (PsA) who have shown inadequate response or intolerance to 1 or 2 biologic therapies or 1 DMARD therapy. In addition, no specific safety issues were observed at 24 weeks in the phase 3 randomised, double-blind KEEPsAKE 2 trial [1].

Risankizumab is a humanised, monoclonal antibody targeting IL-23. This interleukin has been implicated in the pathogenesis of PsA [2]. Currently, risankizumab is approved for the treatment of moderate-to-severe plaque psoriasis in adults. In the KEEPsAKE 2 trial (NCT03671148), adult patients with active PsA (≥5 tender joints and ≥5 swollen joints) and an inadequate response to biologics or conventional synthetic DMARDs (n=444) were randomised to risankizumab (n=224, mean age 53) or placebo (n=219, mean age 52). Risankizumab 150 mg was administrated at week 0 and 4, followed by once every 12 weeks. A double-blind period of 24 weeks is followed by an open-label extension period. Prof. Andrew Östör (Monash University, Australia) presented the week 24 results. The primary endpoint was a ≥20% improvement on the American College of Rheumatology (ACR)20 response at week 24.

The primary endpoint was met (see Figure). Significantly more patients in the risankizumab arm (53%) had an improvement in ACR20 score than patients in the placebo arm (26.5%; P<0.001).

Figure: The ACR20 response for treatment with risankizumab versus placebo [1]

*P0.05; ***P≤0.001 versus placebo.

Furthermore, all ranked secondary endpoints were met: change in Health Assessment Questionnaire Disability Index (HAQ-DI; risankizumab -0.22 vs placebo -0.05;  P<0.001); Psoriasis Area and Severity Index 90 (PASI 90; risankizumab 55.0% vs placebo 10.2%; P<0.001), ACR20 at week 16 (risankizumab 48.3% vs placebo 25.3%; P<0.001), minimal disease activity (risankizumab 25.6% vs placebo 11.4%; P<0.001), change in SF-36 PCS (risankizumab 5.9 vs placebo 2.0; P<0.001), and change in FACIT-Fatigue (risankizumab 4.9 vs placebo 2.6; P<0.01). Non-ranked secondary efficacy endpoints demonstrated patient benefits of risankizumab as well. These included ACR50 response (risankizumab 26.3% vs placebo 9.3%; P<0.001), ACR70 response (risankizumab 12.0% vs placebo 5.9%; P<0.05), resolution of enthesitis (risankizumab 42.9% vs placebo 30.4%; P<0.01), and resolution of dactylitis (risankizumab 72.5% vs 42.1%;  P<0.001).

Treatment-emergent adverse events (AEs) occurred in 55.4% (risankizumab) and 54.8% (placebo) of patients. Respectively, 4.0% (risankizumab) and 5.5% (placebo) of the treatment-emergent AEs were considered serious. Active tuberculosis or other opportunistic infections were not observed in either treatment group. No anaphylactic reactions were reported. Other than upper respiratory tract infections, no treatment-emergent AE was observed in ≥5% of the patients in either arm of the study. Prof. Östör concluded that risankizumab was well tolerated  for active PsA and that the safety profile was similar to that of risankizumab treatment in moderate-to-severe psoriasis.

  1. Östör A, et al. Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis, Including Patients With Inadequate Response or Intolerance to Biologic Therapies: 24-Week Results From the Phase 3, Randomized, Double-blind, KEEPsAKE 2 Trial. OP0228, EULAR 2021 Virtual Congress, 2–5 June.

  2. Boutet M-A, et al. Int J Mol Sci. 2018;19(2):530.


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