AbbVie’s Phase 3 AFFIRM Study Achieves Week-12 Crohn’s Remission and 0.5% SAE Rate
AbbVie reported that its Phase 3 AFFIRM study of risankizumab subcutaneous induction achieved significantly higher Crohn’s Disease Activity Index remission and endoscopic response rates at week 12 versus placebo. The safety profile remained consistent, with serious adverse events at 0.5% compared to 3.1% for placebo.
1. Trial Design and Efficacy Results
The Phase 3 AFFIRM study randomized adult patients with moderately to severely active Crohn’s disease to risankizumab subcutaneous induction versus placebo. At week 12, significantly higher proportions of risankizumab patients achieved Crohn’s Disease Activity Index clinical remission and endoscopic response compared to placebo.
2. Safety and Tolerability
During the 12-week double-blind period, risankizumab’s safety profile remained consistent with no new risks identified. Serious adverse events occurred in 0.5% of risankizumab patients versus 3.1% on placebo, with upper respiratory tract infection, abdominal pain and arthralgia as the most common adverse events.
3. Next Steps and Commercial Implications
Positive topline AFFIRM results support AbbVie’s plans for regulatory submission in Crohn’s disease, potentially expanding its immunology portfolio. Analysts will watch timing of filings and projected market uptake, where risankizumab could compete with other IL-23 inhibitors in a multi-billion-dollar gastroenterology market.