AbbVie today announced that it has submitted applications seeking approval for SKYRIZI® (risankizumab-rzaa, 150 mg) to the U.S. Food and Drug Administration (FDA) and for SKYRIZI® (risankizumab, 150 mg) to the European Medicines Agency (EMA) for the treatment of adults with active psoriatic arthritis. The submissions were supported by two pivotal Phase 3 studies, KEEPsAKE-1 and KEEPsAKE-2, which evaluated SKYRIZI in adults with active psoriatic arthritis including those who had responded inadequately or were intolerant to biologic therapy and/or non-biologic disease-modifying anti-rheumatic drugs (DMARDs)
“Most patients living with psoriatic arthritis experience both skin and joint disease which can be especially burdensome. Despite advancements, many patients cannot find relief from the signs and symptoms of this disease,” said Michael Severino, M.D., vice chairman and president, AbbVie. “We are dedicated to providing options that can help more patients living with psoriatic arthritis reach their treatment goals.”
In the Phase 3 KEEPsAKE-1 and KEEPsAKE-2 studies, SKYRIZI demonstrated significant improvements in disease activity (as measured by ACR20 response and minimal disease activity), skin clearance (as measured by at least a 90 percent improvement in Psoriasis Area Severity Index [PASI 90]) and physical function (as measured by the Health Assessment Questionnaire Disability Index [HAQ-DI]) at week 24 versus placebo. In both studies, significantly more patients treated with SKYRIZI achieved the primary endpoint of ACR20 response at week 24 versus placebo. The safety profile of SKYRIZI in these studies was generally consistent with the safety profile of SKYRIZI in plaque psoriasis, with no new safety risks observed.