AbbVie Announces Phase 3 AFFIRM Trial Data: Skyrizi Achieves 35.8% Endoscopic Remission in Crohn’s Disease

AbbVie Inc. announced new Phase 3 AFFIRM trial data demonstrating endoscopic remission and ulcer-free endoscopy outcomes with subcutaneous Skyrizi in adults with active Crohn’s disease. The findings were presented at the American College of Gastroenterology 2026 Annual Scientific Meeting and build on previously reported positive Week 12 results showing superiority in the co-primary endpoints of clinical remission and endoscopic response versus placebo.

Crohn’s disease is a chronic inflammatory bowel condition causing gastrointestinal inflammation, which can lead to persistent diarrhea, abdominal pain, and complications requiring surgical intervention.

Skyrizi (risankizumab-rzaa) is an interleukin-23 (IL-23) inhibitor that selectively binds to the p19 subunit of IL-23, a cytokine involved in inflammatory pathways. The therapy is already approved for Crohn’s disease and other immune-mediated conditions.

The Phase 3 AFFIRM trial randomized 289 adults with moderately to severely active Crohn’s disease in a 2:1 ratio to receive subcutaneous Skyrizi or placebo. The co-primary endpoints were clinical remission and endoscopic response at Week 12.

At Week 12, endoscopic remission was achieved by 27.7% of patients receiving Skyrizi, compared with 10.2% in the placebo group. Ulcer-free endoscopy was reported in 26.2% of Skyrizi-treated patients versus 10.2% receiving placebo.

At Week 24, endoscopic remission reached 35.8% with Skyrizi, compared with 9.1% for placebo. Ulcer-free endoscopy was reported in 36.6% of Skyrizi recipients versus 9.1% with placebo.

Among patients who had not previously received advanced therapies, Week 24 endoscopic remission and ulcer-free endoscopy rates were 45.1% and 49.0%, respectively.

Efficacy outcomes beyond Week 12 were evaluated in patients who achieved a clinical response during induction and subsequently entered the maintenance phase. Safety findings through Week 24 were consistent with the established risankizumab profile, and no new safety signals were identified.

Subcutaneous induction treatment with Skyrizi for Crohn’s disease is currently under regulatory review by the U.S. Food and Drug Administration and the European Medicines Agency.

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