KEEPsAKE trials: Risankizumab well tolerated, improves signs, symptoms in refractory PsA
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Risankizumab provides statistically greater improvements in signs and symptoms relative to placebo, and is well tolerated among patients with psoriatic arthritis, according to data presented at ACR Convergence 2021.
“Risankizumab is a humanized immunoglobulin monoclonal antibody that specifically inhibits interleukin-23 by binding to its p19 subunit,” Andrew Ostor, MD, of Monash University, in Melbourne, Australia, told attendees at the virtual meeting. “It is approved for the treatment of moderate-to-severe plaque psoriasis in adults.”
“The phase 3 risankizumab psoriatic arthritis program includes two randomized, double-blind, placebo-controlled studies: KEEPsAKE 1, looking at risankizumab vs. placebo in adults with active psoriatic arthritis who have a history of inadequate response or intolerance to at least one DMARD therapy, and; KEEPsAKE 2, showing risankizumab vs. placebo in adults with active psoriatic arthritis who have a history of inadequate response or intolerance to one or two biologic therapies, and/or at least one DMARD therapy,” he added.
To examine the safety and efficacy of risankizumab (Skyrizi; AbbVie, Boehringer Ingelheim) in patients with PsA with prior inadequate response to DMARD or biologic therapies, Ostor and colleagues reported on the integrated week-24 results of the KEEPsAKE 1 and KEEPsAKE 2 trials. Both trials recruited adults with active PsA, active plaque psoriasis or nail psoriasis, with at least 5 swollen and tender joints. In addition, both trials randomly assigned patients 1:1 to received blinded subcutaneous risankizumab 150 mg or placebo at weeks 0, 4 and 16.
A total of 1,407 patients were enrolled in the two studies, with 1,354 completing the 24-week assessments; among these patients, 688 received risankizumab and 666 received a placebo. Demographics and baseline disease characteristics were similar between the two groups, the researchers noted. For this pooled analysis, Ostor and colleagues set a primary endpoint of the proportion of patients who achieved the ACR20 response at week 24. The researchers assessed safety throughout the study. The trials’ open-label period, with all participants receiving risankizumab, is ongoing.
According to the researchers, 55.5% of participants in the risankizumab group achieved ACR20 at week 24, compared with 31.3% of those who received placebo (P < .001). In addition, patients treated with risankizumab demonstrated greater improvements than those in the placebo group in all secondary clinical and patient-reported outcome endpoints. The researchers report no new safety signals in patients who received risankizumab.
“Patients treated with risankizumab showed significantly greater improvements in the signs and symptoms of psoriatic arthritis compared to those treated with placebo from the KEEPsAKE 1 and 2 studies,” Ostor said. “Risankizumab was well tolerated and showed no new safety signals over those seen in the trial program for psoriasis.”
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Ostor A. Abstract 0453. Presented at: ACR Convergence 2021; November 5-9, 2021 (virtual meeting).
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