Skyrizi phase III results demonstrate improvements in disease activity across joint and skin symptoms among psoriatic arthritis patients.- AbbVie

AbbVie announced positive top-line results from two Phase III studies in adults with active psoriatic arthritis, KEEPsAKE-1 and KEEPsAKE-2 , showing that significantly more patients treated with risankizumab (150 mg) achieved the primary endpoint of ACR20 response at week 24 versus placebo. In KEEPsAKE-1 and KEEPsAKE-2, 57 and 51 percent of patients receiving risankizumab achieved ACR20 response at week 24, respectively, versus 34 and 27 percent receiving placebo (p<0.001). results of ranked secondary endpoints showed significant improvements in skin clearance (as measured by at least a 90 percent improvement in psoriasis area severity index [pasi 90]), physical function (as measured by the health assessment questionnaire disability index [haq-di]) and minimal disease activity (mda) at week 24. these two phase iii studies evaluated risankizumab in adult patients with active psoriatic arthritis, and included patients who had responded inadequately or were intolerant to biologic therapy and or non-biologic disease-modifying anti-rheumatic drugs (dmards). about keepsake-1 and keepsake-: keepsake-1 and keepsake-2 are both phase iii, multicenter, randomized, double-blind, placebo-controlled studies designed to evaluate the safety and efficacy of risankizumab in adult patients with active psoriatic arthritis. keepsake-1 evaluated risankizumab in patients who had an inadequate response or intolerance to at least one dmard. keepsake-2 evaluated risankizumab in patients who had an inadequate response or intolerance to biologic therapy and or dmards. patients were randomized to risankizumab 150 mg or placebo followed by risankizumab 150 mg at week 24. the primary endpoint for both studies was the achievement of acr20 response at week 24 from the treatment with the study medication. ranked secondary endpoints included change from baseline in haq-di, as well as the achievement of pasi 90 and mda at week 24. other secondary endpoints included acr50 and acr70 (not controlled for multiplicity) at week 24. the studies are ongoing, and the long-term extension remains blinded to evaluate the long-term safety, tolerability and efficacy of risankizumab in patients who have completed the placebo-controlled period. more information on these trials can be found at ww.clinicaltrials.gov (keepsake-1: nct03675308; keepsake-2: nct03671148).>