AbbVie Presents New Phase 3 AFFIRM Data Showing Clinical and Endoscopic Outcomes With Subcutaneous SKYRIZI® (risankizumab-rzaa) in Patients With Moderately to Severely Active Crohn's Disease
Key Highlights
- ➤SKYRIZI SC achieved 35.8% week-24 endoscopic remission overall
- ➤SKYRIZI SC achieved 36.6% week-24 ulcer-free endoscopy overall
- ➤Advanced therapy-naïve patients reached 45.1% endoscopic remission
- ➤Advanced therapy-naïve patients reached 49.0% ulcer-free endoscopy
- ➤FDA and EMA are reviewing subcutaneous induction applications
Expert Statements
Kori Wallace, M.D., Ph.D., Vice president, global head of immunology clinical development, AbbVie
“Controlling underlying inflammation can limit the amount of time people living with Crohn's disease spend experiencing debilitating flares”
Kori Wallace, M.D., Ph.D., Vice president, global head of immunology clinical development, AbbVie
“The findings reported in AFFIRM are important because not only were the endoscopic outcomes higher with SKYRIZI, but they were achieved after induction, demonstrating the potential of subcutaneous SKYRIZI for helping patients achieve disease control early in their treatment journey.”
Millie D. Long, M.D., MPH, Chief, division of gastroenterology and hepatology, University of North Carolina at Chapel Hill, and lead investigator of AFFIRM
“In clinical practice, we're making treatment decisions for patients at very different points in their disease, from those starting their first advanced therapy to those who have already cycled through several,”
Millie D. Long, M.D., MPH, Chief, division of gastroenterology and hepatology, University of North Carolina at Chapel Hill, and lead investigator of AFFIRM
“Seeing the endoscopic improvements in both advanced therapy-naïve and treatment-experienced patients observed in AFFIRM gives clinicians meaningful evidence to inform decisions across the treatment journey.”
AbbVie Presents New Phase 3 AFFIRM Data Showing Clinical and Endoscopic Outcomes With Subcutaneous SKYRIZI® (risankizumab-rzaa) in Patients With Moderately to Severely Active Crohn's Disease PR Newswire
* Higher rates of endoscopic remission and ulcer-free endoscopy were observed following subcutaneous SKYRIZI(® )(risankizumab-rzaa)treatment versus placebo(i) * Results build on previously reported week 12 findings in which SKYRIZI achieved superiority in the co-primary endpoints of clinical remission and endoscopic response versus placebo * These data support the application to the U.S. Food and Drug Administration seeking approval of a subcutaneous induction dosing regimen for SKYRIZI for patients with moderately to severely active Crohn's disease NORTH CHICAGO, Ill., Oct. 13, 2026 /PRNewswire/ -- AbbVie today announced new findings from the Phase 3 AFFIRM study evaluating a new option for induction treatment with SKYRIZI(®) (risankizumab-rzaa) in adults with moderately to severely active Crohn's disease (CD). Presented at the American College of Gastroenterology 2026 Annual Scientific Meeting, the findings build on the previously reported efficacy results of subcutaneous (SC) SKYRIZI(®) treatment, showing new endoscopic remission(ii) and ulcer-free endoscopy(iii )outcomes for patients receiving SKYRIZI subcutaneously.(i)
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