SKYRIZI shows strong endoscopic outcomes in Phase III Crohn’s disease study

AbbVie has reported new Phase III findings showing that subcutaneous SKYRIZI, also known as risankizumab, produced meaningful endoscopic improvements in adults with moderately to severely active Crohn’s disease.

The results come from the AFFIRM study and were presented at the 2026 American College of Gastroenterology Annual Scientific Meeting.

The latest analysis builds on previously reported week 12 data in which subcutaneous SKYRIZI met both co-primary endpoints of clinical remission and endoscopic response compared with placebo.

New findings focused on deeper measures of disease control, including endoscopic remission and complete absence of ulcers.

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

Among patients who had ulcers at the beginning of the study, 36.6% achieved ulcer-free endoscopy following induction and maintenance treatment.

Higher response rates were observed among patients who had not previously received advanced therapy.

In this subgroup, 45.1% achieved endoscopic remission and 49.0% achieved ulcer-free endoscopy.

AbbVie said these were the highest rates recorded across the evaluated patient subgroups.

The company said the results support the potential for a fully subcutaneous treatment pathway that could allow patients to administer both induction and maintenance therapy themselves.

Subcutaneous induction with SKYRIZI is currently under regulatory review by the U.S. Food and Drug Administration and European Medicines Agency for adults with moderately to severely active Crohn’s disease.

Kori Wallace, MD, PhD, Vice President and Global Head of Immunology Clinical Development at AbbVie, said controlling underlying inflammation is an important treatment objective because it can reduce the burden of disease flares.

She said the AFFIRM findings suggest subcutaneous SKYRIZI may help patients achieve early and deeper disease control.

The study included a population with long-standing and difficult-to-treat Crohn’s disease.

Around 65% of patients had previously experienced an inadequate response to advanced therapies.

Participants had been living with Crohn’s disease for an average of more than seven years and entered the study with substantial intestinal inflammation.

Millie D. Long, MD, MPH, Chief of the Division of Gastroenterology and Hepatology at the University of North Carolina at Chapel Hill and lead investigator of AFFIRM, said the study provides evidence across patients at different stages of their treatment journey.

She noted that improvements were observed both in people receiving their first advanced therapy and in patients who had already received several previous treatments.

The findings add to AbbVie’s regulatory applications seeking approval of a subcutaneous induction regimen for SKYRIZI in Crohn’s disease.

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Related Topics and Keywords

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