AbbVie reports positive Phase 3 Crohn’s disease data for subcutaneous Skyrizi
AbbVie reported new Phase 3 AFFIRM results for subcutaneous SKYRIZI in adults with moderately to severely active Crohn’s disease on October 13, 2026. At week 24, 35.8% of treated patients achieved endoscopic remission versus 9.1% on placebo, while 36.6% achieved ulcer-free endoscopy. The findings were presented at the American College of Gastroenterology 2026 Annual Scientific Meeting and support AbbVie’s application for subcutaneous induction approval, which remains under review by the FDA and EMA.
Why it matters
The data provide evidence for a potential patient-administered induction option in Crohn’s disease, but the expanded use is not yet approved. AbbVie’s application remains subject to FDA and EMA review.
Key facts
- 1AFFIRM included 289 patients in a global, randomized, placebo-controlled Phase 3 study. news.abbvie.com
- 2At week 24, endoscopic remission occurred in 35.8% of patients receiving subcutaneous SKYRIZI and 9.1% of those receiving placebo. stocktitan.net
- 3At week 24, ulcer-free endoscopy was reported for 36.6% of the overall SKYRIZI group versus 9.1% of the placebo group. stocktitan.net
- 4Among patients without prior advanced-therapy failure, week-24 rates were 45.1% for endoscopic remission and 49.0% for ulcer-free endoscopy. stocktitan.net
- 5Subcutaneous induction for Crohn’s disease is under regulatory review by the U.S. Food and Drug Administration and the European Medicines Agency. news.abbvie.com
Summary written by AlphAI AI Desk from 6 of 6 sources. Not investment advice. Figures are as stated by the linked sources.