AbbVie has 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 and ulcer-free endoscopy outcomes for patients receiving SKYRIZI subcutaneously.

After treatment with SKYRIZI, 35.8 percent of patients achieved endoscopic remission, or the healing of the intestinal lining with little to no visible inflammation.

Across subgroups, 36.6 percent of patients who had ulcers at the start of the study achieved the complete absence of ulcers, known as ulcer-free endoscopy, after induction and maintenance treatment.

Among advanced therapy-naïve patients, rates were higher, with 45.1 percent achieving endoscopic remission and 49 percent achieving ulcer-free endoscopy, representing the highest rates observed across the evaluated subgroups.

Evaluating SC SKYRIZI against stringent endoscopic outcomes demonstrates its potential to help CD patients achieve deeper control of underlying inflammation with a fully patient-administered regimen. SC induction with SKYRIZI for adults with moderately to severely active CD is currently under regulatory review with the US Food and Drug Administration (FDA) and European Medicines Agency (EMA).

Kori Wallace, MD, PhD, Vice President, Global Head of Immunology Clinical Development, AbbVie, said, "Controlling underlying inflammation can limit the amount of time people living with Crohn's Disease spend experiencing debilitating flares. 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."

AFFIRM included patients with longstanding, difficult-to-treat CD; 65 percent had previously experienced an inadequate response to advanced therapies. Patients had lived with the disease for an average of over 7 years and had substantial intestinal inflammation at study entry.

Millie D Long, MD, MPH, Chief, Division of Gastroenterology and Hepatology, University of North Carolina, Chapel Hill, and lead investigator of AFFIRM, said, "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. 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."

Safety findings through week 24 were consistent with the known safety profile of risankizumab, with lower rates of Treatment-Emergent Adverse Events (TEAEs) observed in the risankizumab treatment groups versus placebo during both induction and maintenance. Rates of Adverse Events (AEs) of special interest remained low, and no new safety signals were identified.