Subcutaneous risankizumab (Skyrizi) produced endoscopic remission in 35.8% of patients with moderately to severely active Crohn's disease at week 24 versus 9.1% on placebo in the Phase III AFFIRM study, presented at the American College of Gastroenterology 2026 Annual Scientific Meeting. The data accompany regulatory applications for the subcutaneous induction regimen, which is under review at the FDA and the EMA, with AbbVie submitting the EMA application in August 2026.
The 289-patient, placebo-controlled trial randomized adults 2:1; 65% had previously failed at least one advanced therapy. Week 24 endoscopic remission was 45.1% versus 6.7% in advanced therapy-naïve patients and 30.1% versus 10.3% in advanced therapy inadequate responders. No p-values or confidence intervals were reported, and week 24 figures derive from patients who achieved clinical response during induction rather than the full randomized population. Safety was described as consistent with the known risankizumab profile, with no new signals identified; no numerical adverse event rates were disclosed.
The findings build on AFFIRM's previously reported week 12 results, announced in March 2026, when subcutaneous risankizumab met both co-primary endpoints of CDAI clinical remission and endoscopic response versus placebo. AbbVie submitted its US regulatory application for subcutaneous induction in April 2026, followed by an EU application in August.