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New Phase 3 AFFIRM Findings on SKYRIZI® in Crohn's Disease

AbbVie recently presented new data from the Phase 3 AFFIRM study, showcasing the effectiveness of SKYRIZI® (risankizumab-rzaa) as an induction treatment for adults suffering from moderately to severely active Crohn's disease (CD). As revealed during the American College of Gastroenterology's 2026 Annual Scientific Meeting, the results reaffirm the promising efficacy of this subcutaneous treatment option.

The study demonstrated notable enhancements in endoscopic remission and ulcer-free endoscopy rates among participants treated with SKYRIZI compared to a placebo. Specifically, 35.8% of patients achieved endoscopic remission — meaning their intestinal lining healed with minimal to no visible inflammation. In subgroup analyses, 36.6% of patients with ulcers at baseline achieved ulcer-free endoscopy after both induction and maintenance treatments. Impressively, among treatment-naïve patients, those statistics rose to 45.1% for endoscopic remission and 49.0% for ulcer-free status. This indicates that SKYRIZI's benefits extend across different patient demographics.

The efficacy seen in the AFFIRM study is particularly meaningful, as many individuals enrolled had experienced inadequate responses to prior advanced therapies. 65% had not found relief from previous treatments, highlighting the necessity for effective new options in this space. The average patient's struggle with Crohn's disease lasted over seven years, during which they endured significant intestinal inflammation and the associated burdens on their quality of life.

Dr. Kori Wallace from AbbVie emphasized the study's importance, mentioning how controlling inflammation can help patients reduce the duration and severity of disease flares. With these findings, the company is looking to gain approval from the U.S. Food and Drug Administration (FDA) for a subcutaneous induction regimen for SKYRIZI, which could play a critical role in early disease management for patients.

The AFFIRM study followed a stringent protocol assessing the safety and efficacy of SKYRIZI. In its design, patients were randomly allocated to receive either the SKYRIZI treatment or a placebo, allowing for clear comparisons of outcomes. The co-primary endpoints included Clinical Remission and endoscopic response rates at the 12-week mark, with additional assessments extending through week 24.

Notably, the safety findings through the 24-week period aligned with the expected safety profile of risankizumab. Adverse events were less frequent in the SKYRIZI group when compared to those receiving a placebo, and no new safety signals emerged, underscoring the treatment's tolerability.

Understanding Crohn's Disease

Crohn's disease remains a complex, chronic condition characterized by inflammation primarily in the gastrointestinal tract. Symptoms like severe abdominal pain and persistent diarrhea can severely impact patients' lives and often lead to complications requiring surgical intervention. The unpredictable nature of this condition not only causes physical pain but also engenders emotional and economic stress, reinforcing the need for innovative treatment approaches like SKYRIZI.

AbbVie is committed to revolutionizing care for immune-mediated conditions, continuing to invest in clinical research that addresses unmet patient needs. Through the ongoing study of SKYRIZI, the company aims to enhance the treatment landscape for Crohn's disease, ultimately helping thousands of sufferers manage their condition effectively. For more information about this trial and its findings, visit ClinicalTrials.gov and search for NCT06063967.

Conclusion

These recent results from the Phase 3 AFFIRM study showcase the significant promise of SKYRIZI as a treatment option for individuals with Crohn's disease. With the potential for better management of the disease through improved control of inflammation, further regulatory approvals could soon make this treatment broadly available. AbbVie’s ongoing commitment to immunology ensures that they will continue to advocate for better patient outcomes and quality of life, ultimately transforming how chronic conditions like Crohn's disease are managed.