AbbVie SKYRIZI Phase 3 AFFIRM Delivers 55% Remission and 44% Endoscopic Response
Phase 3 AFFIRM data in 289 adults showed SKYRIZI subcutaneous induction delivered 55% clinical remission and 44% endoscopic response at week 12 versus 30% and 14% on placebo (p<0.0001). Safety profile matched known data with serious adverse events in 0.5% of treated patients versus 3.1% on placebo.
1. AFFIRM Trial Design and Patient Population
The AFFIRM study randomized 289 adults with moderately to severely active Crohn’s disease in a 2:1 ratio to receive SKYRIZI subcutaneous induction or placebo. Sixty-five percent of participants had failed at least one advanced therapy, with 50% having failed two or more prior treatments.
2. Efficacy Outcomes
At week 12, 55% of patients on SKYRIZI achieved Crohn’s Disease Activity Index clinical remission versus 30% on placebo, while 44% achieved endoscopic response compared to 14% with placebo (p<0.0001 for both endpoints). Among Week 12 responders who continued into maintenance, 67% reached remission and 57% maintained endoscopic response at week 24.
3. Safety Profile and Next Steps
The safety profile for SKYRIZI induction was consistent with prior Crohn’s data, with serious adverse events in 0.5% of treated patients versus 3.1% on placebo and common events including upper respiratory infections and abdominal pain. AbbVie plans regulatory submissions for Crohn’s disease label expansion and will present full results in upcoming medical congresses.