AbbVie has reported results from new Phase III data analyses of KEEPsAKE-1 and KEEPsAKE-2 clinical trials where risankizumab (Skyrizi) treatment offered improved signs and symptoms of psoriatic arthritis in adults.
An interleukin-23 (IL-23) inhibitor, Skyrizi selectively prevents IL-23 by attaching to its p19 subunit.
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The multicentre, randomised, double-blind, placebo-controlled Phase III KEEPsAKE-1 and KEEPsAKE-2 studies analysed the safety and efficacy of risankizumab in adult active psoriatic arthritis patients.
In the KEEPsAKE-1 trial, risankizumab was assessed in subjects with an inadequate response or intolerance to at least one non-biologic disease-modifying anti-rheumatic drug (DMARD).
While KEEPsAKE-2 investigated risankizumab in those with an inadequate response. Subjects who had an intolerance to biologic therapy and/or DMARDs were also evaluated in this trial.
In the initial phase of the studies, subjects were randomised and given risankizumab or a placebo until week 24.
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By GlobalDataThe open-label extension period began at week 24 and all subjects received risankizumab.
According to the latest long-term data from the open-label extension period, 70% and 58% of subjects who first received risankizumab attained American College of Rheumatology 20 (ACR20) response in the trials KEEPsAKE-1 and KEEPsAKE-2, respectively at one year.
ACR20 response achievement at week 24 was the primary goal of the trials, which sustained through 52 weeks.
Of the patients who initially received risankizumab, 43% in KEEPsAKE-1 and 32% in KEEPsAKE-2 attained ACR50 response while 26% and 17% in KEEPsAKE-1 and KEEPsAKE-2, respectively, had ACR70 response at one year.
Furthermore, 68% and 64% of subjects who were initially given risankizumab and having a body surface area ≥3% at enrolment attained a 90% decline in the Psoriasis Area and Severity Index (PASI 90) in KEEPsAKE-1 and KEEPsAKE-2 trials, respectively, at one year.
Both the trials also showed durable safety profiles in line with the data reported at week 24, without any new safety findings noted from week 24 to week 52.
AbbVie research and development senior vice-president and chief scientific officer Thomas Hudson said: “Millions of people still suffer daily with symptoms of psoriatic arthritis, driving us to advance treatment options for these patients.
“These new analyses at one year support the potential of risankizumab to maintain improvements across multiple manifestations of psoriatic arthritis.”
In January, AbbVie reported positive top-line results from two ongoing Phase III studies, KEEPsAKE-1 and KEEPsAKE-2, of 150mg Skyrizi (risankizumab) in adults with active psoriatic arthritis.
