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AbbVie Announces Positive Topline Results from Phase 3 AFFIRM Study Evaluating SKYRIZI® (Risankizumab) Subcutaneous Induction in Patients with Crohn's Disease
AbbVie (NYSE: ABBV) today announced positive topline results from the Phase 3, randomized, placebo-controlled, double-blind AFFIRM study evaluating the efficacy and safety of risankizumab (SKYRIZI®) subcutaneous (SC) induction treatment versus placebo in adult patients with moderately to severely active Crohn's disease (CD).1
About this update from Abbvie Inc.
[{"type":"list","items":[{"val":[{"type":"text","content":"In the Phase 3 AFFIRM study in adults with moderately to severely active Crohn's disease, risankizumab (SKYRIZI®) achieved superiority for the co-primary and ranked secondary endpoints at week 12 for induction delivered by subcutaneous (SC) injection versus placebo1","length":275,"tagName":"p"}]},{"val":[{"type":"text","content":"These data support strong efficacy of risankizumab in Crohn's disease while providing potential for an induction choice for patients1","length":142,"tagName":"p"}]},{"val":[{"type":"text","content":"The safety profile of risankizumab SC induction was consistent with its known profile in Crohn's disease, with no new safety risks observed1","length":149,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":566,"olType":false},{"type":"text","content":"NORTH CHICAGO, Ill., March 2, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced positive topline results from the Phase 3, randomized, placebo-controlled, double-blind AFFIRM study evaluating the efficacy and safety of risankizumab (SKYRIZI®) subcutaneous (SC) induction treatment versus placebo in adult patients with moderately to severely active Crohn's disease (CD).1","length":382,"tagName":"p"},{"type":"text","content":"The AFFIRM study results show significantly greater proportions of patients treated with risankizumab SC induction achieved the co-primary endpoints of Crohn's Disease Activity Index (CDAI) clinical remissiona (55% vs. 30%; p<0.0001) and endoscopic responseb (44% vs. 14%; p<0.0001) at week 12 compared to placebo.1 Among patients with clinical responsec after 12 weeks of risankizumab SC induction treatment followed by 12 weeks of maintenance, 67% achieved CDAI clinical remission at week 24 and 57% achieved endoscopic response at week 24.1","length":563,"tagName":"p"},{"type":"text","content":"This Phase 3 study enrolled a predominantly treatment-refractory population** (65%) with 50% of those patients having failed two or more advanced therapies and 23% having failed ustekinumab and 12% having failed a Janus kinase inhibitor (JAKi).1","length":245,"tagName":"p"},{"type":"text","content":""This study evaluated a difficult-to-treat Crohn's disease patient population, including a majority with a prior failure to advanced therapy, and thes...