AbbVie has reported positive top-line results from two ongoing Phase III studies, KEEPsAKE-1 and KEEPsAKE-2, of Skyrizi (risankizumab) 150mg in adults with active psoriatic arthritis.
An interleukin-23 (IL-23) inhibitor, Skyrizi selectively prevents IL-23 by binding to its p19 subunit.
IL-23 is a cytokine involved in inflammatory processes and is thought to be linked to several chronic immune-mediated diseases, including psoriasis.
The multi-centre, randomised, double-blind, placebo-controlled Phase III KEEPsAKE-1 and KEEPsAKE-2 studies analysed the safety and efficacy of risankizumab in adult patients with active psoriatic arthritis.
KEEPsAKE-1 is analysing risankizumab in those who had an inadequate response or intolerance to at least one non-biologic disease-modifying anti-rheumatic drug (DMARD), while KEEPsAKE-2 is assessing the therapy in patients who had an inadequate response or intolerance to biologic therapy and/or DMARDs.
In the trials, patients were randomly given risankizumab 150mg or placebo followed by another dose at week 24.
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Data from the trials showed that significantly more patients treated with risankizumab 150mg met the primary endpoint of ACR20 response at week 24 as compared to placebo.
In KEEPsAKE-1 and KEEPsAKE-2, 57% and 51% of patients in the treatment arm achieved the primary endpoint of ACR20 response at week 24, respectively, as compared to 34% 27% in the placebo arm.
Furthermore, at week 24, the ranked secondary endpoint data showed significant improvements in skin clearance, physical function and minimal disease activity.
The observed safety profile of risankizumab is so far in line with the previously known ones in psoriasis patients.
AbbVie vice chairman and president Michael Severino said: “We are encouraged by these positive results showing the potential of risankizumab in psoriatic arthritis.
“These results underscore our commitment to research that can provide health care practitioners with important treatment options for patients with psoriatic disease.”
Last February, AbbVie reported that the Phase III SELECT-PsA 1 study of Rinvoq (upadacitinib) met its primary endpoint in adults with active psoriatic arthritis.