Shots:

• The submission is based on two P-III studies KEEPsAKE-1 & -2 studies involves assessing Skyrizi (150mg) vs PBO in adult patients with active PsA who had an inadequate response or intolerant to biologic therapy and/or non-biologic DMARDs respectively
• The 1EP and 2EP of both studies showed ACR20 response @24wks.- improvements in disease activity- skin clearance- 90% improvement in PASI 90 & physical function as measured by HAQ-DI
• The safety profile was generally consistent with the known profile of Skyriz in psoriasis patients- with no new safety risks observed. Skyrizi is an IL-23 inhibitor- being developed in collaboration with Boehringer Ingelheim

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