KEEPsAKE 2 supports risankizumab for the treatment of PsA
medwireNews: The interleukin (IL)-23 inhibitor risankizumab is a promising treatment option for psoriatic arthritis (PsA), suggest results from the KEEPsAKE 2 trial presented at the EULAR 2021 Virtual Congress.
Andrew Östör (Monash University, Cabrini Hospital, and Emeritus Research, Melbourne, Victoria, Australia) and co-investigators randomly assigned 443 participants to receive subcutaneous risankizumab 150 mg or placebo at weeks 0, 4, and 16, followed by an open-label extension period beginning after week 24 in which all patients were given risankizumab at a dose of 150 mg every 12 weeks.
All participants had active PsA and an inadequate response to either conventional or biologic DMARDs. Approximately 95% of patients in both groups had previously received a conventional DMARD, while around 46% had prior biologic exposure.
At week 24, a significantly higher proportion of patients treated with risankizumab versus placebo achieved the primary endpoint of an ACR20 response, at 51.3% versus 26.5%.
ACR50 (26.3 vs 9.3%), ACR70 (12.0 vs 5.9%), and PASI90 (55.0 vs 10.2%) response rates at week 24 were also significantly greater in the risankizumab than the placebo arm. Patients treated with risankizumab experienced significantly greater improvements in enthesitis and dactylitis, as well as FACIT-Fatigue and SF-36 Physical Component Summary scores, relative to those given placebo.
“KEEPsAKE 2 met the primary and all ranked secondary endpoints,” summarized Östör.
When asked by a member of the audience about the suitability of ACR20 response rates as a primary trial endpoint in 2021, he said that patients and physicians “aren’t particularly interested” in this measure in everyday practice, but it is currently “deemed the appropriate outcome measure in clinical trials in order to get [drugs] licensed around the world, and therefore this is the appropriate accepted primary endpoint at this point in time.”
In terms of safety, Östör reported that risankizumab was “well tolerated with a safety profile consistent with that established for risankizumab in the treatment of moderate-to-severe psoriasis.”
In all, 55.4% of participants in the placebo arm experienced treatment-emergent adverse events (TEAEs), as did 54.8% of those given placebo, while TEAEs led to treatment discontinuation in 0.9% and 2.3%, respectively. There were no anaphylactic reactions, and no reports of active tuberculosis or other opportunistic infections.
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