Selective IL-23 inhibition: a new option in active PsA

Results of the KEEPsAKE 1 and 2 trials demonstrated high efficacy of the IL-23 blocker risankizumab in adult patients with active psoriatic arthritis (PsA), independent of previous therapy. Risankizumab also showed an excellent safety profile.

The selective IL-23 inhibitor risankizumab has already been approved for moderate-to-severe psoriasis and is being investigated as a treatment for adults with PsA. At the ACR meeting, 2 presentations covered the phase 3 KEEPsAKE trials, which compared risankizumab with placebo [1,2].

In a plenary session, Prof. Andrew Östör (Monash University, Australia) presented an integrated analysis of data from the KEEPsAKE 1 (NCT03675308) and KEEPsAKE 2 (NCT03671148) studies, including 1,407 patients with active PsA who had inadequate response or intolerance to either ≥1 csDMARDs (KEEPsAKE1) or bDMARDs (KEEPsAKE2). In both trials, patients were randomised (1:1) to receive blinded subcutaneous risankizumab 150 mg (n=707) or placebo (n=700) at weeks 0, 4, and 16. Prof. Östör pointed out the high burden of disability and fatigue in the study population. The primary endpoint for this pooled analysis was the proportion of patients achieving 20% improvement in the ACR20 at week 24.

The primary endpoint was met by 55.5% of patients in the risankizumab group versus 31.3% in the placebo arm, a highly statistically significant difference (P<0.001). Moreover, risankizumab showed significant improvements compared with placebo in all secondary clinical and patient-reported outcomes, e.g. in ACR50 (31.2 vs 10.6%) and ACR70 (14.1 vs 5.0%) response rates. In addition, 53.2% of patients treated with risankizumab compared with 10% in the placebo arm achieved almost a clearance of psoriatic skin lesions (assessed as a 90% improvement of the Psoriasis Area and Severity Index). Superiority was also demonstrated in the physical function, assessed with the Health Assessment Questionnaire Disability Index (HAQ-DI).

Treatment-emergent adverse events (AEs) were noted in 45.5% of patients in the risankizumab group and 43.9% of those given placebo. Serious treatment-emergent AEs were seen in 3% of patients in the risankizumab arm and 4.4% in the placebo arm. So, overall risankizumab was well tolerated with a similar safety profile that is known from psoriasis trials and is the second p19 IL-23 blocker, following guselkumab, to show efficacy in phase 3 PsA trials.

1. Östör A, et al. Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis: 24-Week Integrated Results from 2 Phase 3, Randomized, Double-blind Clinical Trials for CsDMARD-IR and Bio-IR Patients. Abstract 0453, ACR Convergence 2021, 3–10 November.
2. Lidar M, et al. Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis: 24-Week Results from the Phase 3, Randomized, Double-blind Clinical Trial for CsDMARD-IR and Bio-IR Patients. Abstract 0183, ACR Convergence 2021, 3–10 November.

 

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Posted on 14 January, 202222 February, 2024