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Promising Results from Phase 3 AFFIRM Trial of Skyrizi in Crohn's Disease Patients

On March 2, 2026, AbbVie (NYSE: ABBV) announced positive top-line results from the Phase 3 AFFIRM trial, which evaluated the efficacy and safety of subcutaneous administration of Skyrizi (risankizumab) in adults with moderate to severe active Crohn's disease. This randomized, placebo-controlled, double-blind study has provided new insights into potential treatment options for patients who struggle with this challenging condition.

Overview of the AFFIRM Trial

The AFFIRM study primarily included patients who had experienced treatment resistance; 65% of the enrolled participants had not responded to two or more advanced therapies. This subgroup underscores the importance of finding effective treatment options for individuals with limited choices. The trial assessed whether the subcutaneous administration of risankizumab could achieve superior results compared to placebo, particularly in terms of clinical remission and endoscopic improvement.

Key Findings

The results of the study revealed that patients treated with risankizumab achieved significantly higher rates of clinical remission based on the Crohn's Disease Activity Index (CDAI) after 12 weeks compared to those receiving placebo. Specifically, 55% of the risankizumab group reached clinical remission versus 30% in the placebo group (p<0.0001). Additionally, endoscopic improvement was noted in 44% of patients in the risankizumab group, compared to only 14% in the placebo group (p<0.0001).

Among those who continued with maintenance therapy, 67% achieved clinical remission at the 24-week mark, and 57% experienced endoscopic improvement after 24 weeks.

Safety Profile

The safety profile of risankizumab was consistent with existing data, with no new safety risks identified during the study. The most commonly reported adverse events in the risankizumab group included upper respiratory infections, abdominal pain, and joint pain. Remarkably, the rate of serious adverse events was significantly lower in the risankizumab group at 0.5%, compared to 3.1% in the placebo cohort.

Expert Commentary

Dr. Kori Wallace, AbbVie’s Vice President and Global Head of Immunology Clinical Development, emphasized the significance of these results, particularly considering the challenge of treating patients who have not responded to existing advanced therapies. He remarked, “The data reinforces that risankizumab can serve as a powerful and effective treatment option for patients, especially in achieving notable endoscopic improvements.”

Dr. Millie D. Long, Chief of the Division of Gastroenterology and Hepatology at the University of North Carolina at Chapel Hill and Lead Investigator of the AFFIRM trial, commented on the broader impact of the findings. She stated, “Crohn's disease is complex and often debilitating, affecting not just physical health, but quality of life. High rates of endoscopic improvement, especially among patients with a history of treatment failure, suggest that subcutaneous inductions of risankizumab might provide viable therapeutic options.”

Conclusion

The AFFIRM trial demonstrates the potential of risankizumab as a new treatment avenue for patients suffering from moderate to severe Crohn's disease, particularly those who have not found relief from traditional therapies. The results are set to be published in a medical journal and presented at upcoming medical conferences, marking a significant step forward in the management of this challenging condition.

For more information about risankizumab and its implications for Crohn's disease patients, refer to clinical trials and the product's detailed safety documentation. AbbVie continues to innovate towards improving treatment standards in immunology and gastroenterology, with a commitment to addressing pressing health challenges.