medwireNews: Treatment with the interleukin (IL)-23 inhibitor risankizumab may improve outcomes for patients with psoriatic arthritis (PsA), suggests an integrated analysis of data from the KEEPsAKE 1 and 2 studies presented at the ACR Convergence 2021 virtual meeting.
The main findings from KEEPsAKE 2 were previously presented at the EULAR 2021 Virtual Congress, and showed a significant improvement in outcomes with risankizumab versus placebo among patients with active PsA and an inadequate response or intolerance to either conventional or biologic DMARDs.
For the current analysis, these data were pooled with the results of KEEPsAKE 1, which also involved patients with an inadequate response to conventional DMARDs, but excluded those with prior biologic exposure. The integrated analysis of the two phase 3 studies included a total of 1407 patients who were randomly assigned to receive risankizumab 150 mg or placebo at weeks 0, 4, and 16 in one of the trials.
Andrew Östör (Monash University, Melbourne, Victoria, Australia) explained to delegates that the designs of KEEPsAKE 1 and 2 were “very similar,” and “specifically allowed for the integration of these two studies to look at the larger dataset.”
He reported that ACR20 response rates at week 24 – the primary endpoint in both trials – were significantly higher among the 707 individuals treated with risankizumab than among the 700 given placebo, at 55.5% versus 31.3%.
Moreover, ACR50 (31.2 vs 10.6%) and ACR70 (14.1 vs 5.0%) response rates at week 24 were significantly higher in the risankizumab than the placebo arm, as were PASI90 response rates (53.2 vs 10.0%) and mean reductions in HAQ-DI score (0.27 vs 0.08).
Östör remarked that the benefits observed with risankizumab were “consistently positive and similar” irrespective of whether participants had previously been exposed to biologics or not.
In all, 45.5% of patients in the risankizumab group and 43.9% of those given placebo experienced treatment-emergent adverse events (TEAEs), while 3.0% and 4.4%, respectively, experienced serious TEAEs. The presenter said that risankizumab was “well tolerated and showed no new safety signals over those seen in the trial program for psoriasis.”
When asked about where risankizumab should be positioned in the PsA treatment landscape, Östör pointed to the “remarkable effect” of the IL-23 inhibitor on the skin, and also noted that the overall safety profile of this class of agents is “a real positive.”
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