The following is a summary of “Efficacy and safety of risankizumab for active psoriatic arthritis: 52-week results from the KEEPsAKE 1 study ,” published in the June 2023 issue of Rheumatology by Kristensen, et al.
For a study, researchers sought to evaluate the 52-week efficacy and safety of risankizumab 150 mg in patients with active psoriatic arthritis (PsA) who had previously shown inadequate response or intolerance to one or more conventional synthetic DMARDs (csDMARDs).
The study, KEEPsAKE 1, was an ongoing global phase 3 trial of two periods. The first period is a 24-week double-blind, placebo-controlled phase, while the second period is an open-label extension. During the first period, eligible patients were randomly assigned in a 1:1 ratio to receive either subcutaneous risankizumab 150 mg or placebo at weeks 0, 4, and 16. At week 24, all patients who continued in the study received open-label risankizumab 150 mg every 12 weeks until week 208.
The results at week 24 showed that 57.3% of patients treated with risankizumab (n = 483) achieved a 20% or greater improvement in ACR criteria (ACR20), compared to 33.5% of patients who received placebo (n = 481; P < 0.001). At week 52, 70.0% of patients who were initially randomized to receive continuous risankizumab treatment and 63.0% of patients who received a placebo in the first period and later switched to risankizumab at week 24 achieved ACR20. Similar trends were observed for other efficacy measures. Throughout the 52 weeks of treatment, risankizumab demonstrated a consistent safety profile and was well tolerated by patients.
In conclusion, in patients with active PsA who had an inadequate response to csDMARDs, continuous treatment with risankizumab showed strong long-term efficacy and was well tolerated over 52 weeks of treatment.
Source: academic.oup.com/rheumatology/article/62/6/2113/6772502