KEEPsAKE 2: Risankizumab improves signs, symptoms in refractory PsA
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Risankizumab is linked to significantly greater improvements in psoriatic arthritis signs and symptoms than placebo in patients with an inadequate response, or intolerance, to other drugs, according to a speaker at the EULAR 2021 Congress.
“Interleukin-23 has been implicated in the pathogenesis of psoriatic arthritis,” Andrew Östör, MD, MBBS, of Monash University and Cabrini Hospital, in Melbourne, Australia, told attendees at the virtual meeting. “Risankizumab is a humanized immunoglobulin G1 monoclonal antibody that binds to the p19 subunit of IL-23 and selectively inhibits this cytokine. Risankizumab is approved for the treatment of moderate-to-severe plaque psoriasis in adults.”
“This is the phase-3 risankizumab psoriatic arthritis program, which included two randomized, double-blind, placebo-controlled studies,” he added. “KEEPsAKE 1 was risankizumab versus placebo in adults with active psoriatic arthritis who have a history of inadequate response or intolerance to at least one disease-modifying antirheumatic drug therapy. KEEPsAKE 2 was risankizumab versus placebo in adults with active PsA who have a history of inadequate response or intolerance to one or two biologic therapies or to at least one DMARD therapy.”
Östör presented data from the 24-week double-blind period of the KEEPsAKE 2 trial, which aimed to compare the efficacy and safety of risankizumab (Skyrizi, AbbVie), compared with placebo, in patients with PsA who had a prior inadequate response or intolerance to one or two biologics, or at least one conventional synthetic disease-modifying antirheumatic drug. A total of 444 participants were randomized, with 224 assigned to receive 150 mg of subcutaneous risankizumab at weeks 0, 4 and 16. Initially, 220 participants were randomized to receive placebo, but one member of this arm never received the treatment and was excluded from the analysis.
The primary endpoint was the proportion of participants who achieved at least a 20% improvement in the ACR20 at week 24. Ranked secondary endpoints included change in HAQ-DI score, percent achieving PASI90, ACR20 at week 16, percent achieving MDA, change in SF-36 PCS score, and change an FACIT-Fatigue score. The researchers assessed safety throughout the study. In all, 215 participants in the risankizumab group, and 199 of those who receive a placebo, completed week 24. An open-label period with all participants who received risankizumab is ongoing.
According to the researchers, 51.3% of those in the risankizumab group achieved the primary endpoint, compared with 26.5% of those who received placebo (P < .001). In addition, significantly greater proportions of those treated with risankizumab achieved all ranked secondary endpoints, compared with those in the placebo group (P < .009 for FACIT-Fatigue and P < .001 for all others). Serious adverse events were reported in 4% of those treated with risankizumab, compared with 5.5% in the placebo group. Serious infections rates for the two groups were 0.9% and 2.3%, respectively.
“KEEPsAKE 2 met the primary and all ranked secondary endpoints,” Östör said. “A significantly greater proportion of patients treated with risankizumab versus placebo achieved ACR20 at week 24, and treatment with risankizumab resulted in significantly greater improvements in signs and symptoms of PsA, including assessments of disease activity in joints and skin, and patient reported outcomes, compared with placebo in patients who were bio-IR or conventional synthetic DMARD-IR.”
He added: “Risankizumab was well-tolerated with a safety profile consistent with that established for risankizumab in the treatment of moderate-to-severe psoriasis.”
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