The 100-week results from the Phase 3 KEEPsAKE 1 randomized clinical trial found that for patients with active psoriatic arthritis (PsA) who are intolerant to conventional synthetic disease modifying anti-rheumatic drugs (csDMARD), risankizumab showed significant long-term efficacy. Additionally, the study findings published in Rheumatology and Therapy also reported the treatment to be generally well-tolerated, and it maintained a consistent long-term safety profile.
Dr. Kristensen and team conducted the KEEPsAKE 1 trial comprising a 24-week, double-blind, placebo-controlled phase followed by an ongoing open-label extension. Participants were randomly assigned in a 1:1 ratio to receive either 150 mg of risankizumab or a placebo at baseline, week 4, and week 16. Subsequently, after the 24th week, all patients received open-label risankizumab every 12 weeks.
Overall, 86% of the patients completed week 100, with 57%, 71%, and 64% achieving ACR20 at weeks 24, 52, and 100 in the risankizumab group, respectively. In the placebo/risankizumab group, only 33% achieved ACR20 at week 24, but this number increased to 64% at week 52 and remained stable at 62% at week 100 after switching to active treatment. Among the patients who had achieved ACR20 response at week 52, 81% maintained their response at week 100.
Similarly, 25%, 38%, and 38% achieved minimal disease activity at weeks 24, 52, and 100 in the risankizumab group, while 10%, 28%, and 35% achieved MDA at weeks 24, 52, and 100 in the placebo/risankizumab group, respectively. Among the patients who achieved MDA response at week 52, 76% in the risankizumab group and 78% in the placebo/risankizumab group maintained their response at week 100.
Risankizumab, a biologic therapy, is a humanized immunoglobulin G1 monoclonal antibody functioning as an interleukin-23 antagonist, exhibiting specific binding to the p19 subunit of interleukin-23. The efficacy and safety of risankizumab are currently under investigation in patients with PsA through two ongoing global, phase 3, multicenter trials, namely KEEPsAKE 1 and KEEPsAKE 2, conducted simultaneously since 2019. Previous findings from both KEEPsAKE 1 and 2 trials have showcased enhanced improvement in PsA signs and symptoms compared to placebo at week 24, with sustained efficacy observed at week 52.
The current results signify a promising therapeutic option for long-term management, offering durable relief from PsA symptoms while maintaining a stable safety profile. This indicates a significant advancement in the treatment landscape for PsA, providing clinicians and patients with a reliable and effective treatment option for managing this chronic condition over the long term.
Reference
Kristensen LE, Keiserman M, Papp K, McCasland L, White D, Carter K, et al. Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis: 100-Week Results from the Phase 3 KEEPsAKE 1 Randomized Clinical Trial. Rheumatol Ther. 2024 Mar 18.