AbbVie Inc. reported positive topline results from the Phase 3 randomized, placebo-controlled, double-blind AFFIRM study evaluating subcutaneous induction dosing of risankizumab (SKYRIZI) versus placebo in adults with moderately to severely active Crohn’s disease. At week 12, the risankizumab group achieved higher rates of CDAI clinical remission (55% vs. 30%) and endoscopic response (44% vs. 14%) compared with placebo. AbbVie said the safety profile was consistent with the known profile in Crohn’s disease, with upper respiratory tract infection, abdominal pain and arthralgia reported as the most common adverse events. The company stated that full results will be published in an upcoming medical journal and shared at future medical congresses.

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