SKYRIZI Achieves 35.8% Remission in AFFIRM Crohn’s Trial

AbbVie reported new Phase 3 AFFIRM findings on October 13, 2026, evaluating subcutaneous (SC) risankizumab (SKYRIZI) as an induction treatment for adults with moderately to severely active Crohn’s disease. Presented at the American College of Gastroenterology 2026 Annual Scientific Meeting, the findings add Week 24 endoscopic remission and ulcer-free endoscopy outcomes to previously reported Week 12 results.

At Week 12, risankizumab demonstrated superiority over placebo for both co-primary endpoints. Clinical remission, defined as a Crohn’s Disease Activity Index (CDAI) score below 150, was achieved by 55.0% of patients receiving risankizumab, compared with 29.6% receiving placebo (p < 0.0001). Endoscopic response occurred in 44.0% and 14.3% of patients, respectively (p < 0.0001).

AFFIRM (NCT06063967) is a global, randomized, double-blind, placebo-controlled Phase 3 study. A total of 289 patients were randomized in a 2:1 ratio to receive subcutaneous risankizumab or placebo. Approximately 65% of participants had previously experienced an inadequate response to advanced therapies, and patients had lived with Crohn’s disease for an average of more than seven years.

Endoscopic Remission Improved Through Week 24

At Week 12, endoscopic remission was observed in 27.7% of patients receiving subcutaneous risankizumab, compared with 10.2% receiving placebo. By Week 24, the respective rates were 35.8% and 9.1%.

Endoscopic remission was defined as a Simple Endoscopic Score for Crohn’s Disease (SES-CD) of 4 or lower, a reduction of at least two points from baseline, and no individual variable subscore greater than 1.

Ulcer-free endoscopy also favoured risankizumab. Among patients with ulcers at baseline, 36.6% receiving risankizumab achieved an ulcerated surface subscore of zero at Week 24, compared with 9.1% receiving placebo. At Week 12, the corresponding overall rates were 26.2% and 10.2%.

These findings show higher reported endoscopic remission and ulcer-free endoscopy rates with risankizumab. However, the Week 24 results require consideration of the study’s treatment design. The initial placebo-controlled period ran from baseline to Week 12. During the subsequent period, patients received blinded or open-label treatment according to their clinical response at Week 12. Week 24 outcomes therefore should not be interpreted as a simple continuation of the original placebo-controlled comparison in an unchanged population.

Prior Treatment Exposure and Endoscopic Outcomes

Subgroup analyses showed numerically higher Week 24 endoscopic remission rates among advanced therapy-naïve patients than among those with prior advanced therapy failure.

Among advanced therapy-naïve patients, 45.1% achieved endoscopic remission with risankizumab, compared with 6.7% receiving placebo. Ulcer-free endoscopy rates in this subgroup were 49.0% and 6.7%, respectively.

Among patients with prior failure of at least one advanced therapy, endoscopic remission was reported in 30.1% of those receiving risankizumab and 10.3% receiving placebo. The corresponding ulcer-free endoscopy rates were 28.9% and 10.3%.

The findings indicate that endoscopic improvement was observed in both subgroups, with numerically higher rates among patients without prior advanced therapy failure. However, the reported differences do not establish that treatment history caused the variation in outcomes. The announcement does not provide subgroup-specific statistical testing or confidence intervals to establish the significance of these comparisons.

Safety and Mechanism of Action

Through Week 24, safety findings were consistent with the known safety profile of risankizumab. AbbVie reported lower rates of treatment-emergent adverse events in the risankizumab groups than in the placebo groups during induction and maintenance. Rates of adverse events of special interest were low, and no new safety signals were identified. These are sponsor-reported findings, and the announcement does not provide a complete numerical breakdown of adverse events across all treatment periods.

Risankizumab is an interleukin-23 (IL-23) inhibitor that selectively binds the p19 subunit of IL-23, a cytokine involved in inflammatory processes associated with immune-mediated diseases. By inhibiting this pathway, risankizumab targets an important component of the inflammatory response in Crohn’s disease.

Regulatory Status

SKYRIZI is already approved in the United States for adults with moderately to severely active Crohn’s disease using an intravenous (IV) induction regimen followed by subcutaneous maintenance. The AFFIRM study evaluates an alternative induction approach using subcutaneous administration, with the aim of enabling an all-subcutaneous treatment regimen.

AbbVie submitted a supplemental regulatory application to the U.S. Food and Drug Administration on April 27, 2026, followed by an application to the European Medicines Agency on August 27, 2026. Both submissions seek approval for subcutaneous induction in adults with moderately to severely active Crohn’s disease. As reported on October 13, 2026, the proposed regimen remained under regulatory review.

Clinical Interpretation

Overall, AFFIRM adds evidence on the endoscopic outcomes associated with subcutaneous risankizumab induction and subsequent treatment. The Week 12 results demonstrated superiority over placebo for both co-primary endpoints, while the Week 24 findings showed higher reported rates of endoscopic remission and ulcer-free endoscopy with risankizumab. The numerically higher endoscopic remission rate among advanced therapy-naïve patients is a notable subgroup finding, but interpretation must account for prior treatment exposure and the response-dependent treatment design after Week 12.

The findings support AbbVie’s regulatory application for subcutaneous induction. They do not, by themselves, establish how this regimen compares with other induction strategies.

Reference

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, Abbvie, 13 October 2026

A Study to Assess Adverse Events and Change in Disease Activity of Risankizumab Subcutaneous Induction Treatment for Moderately to Severely Active Crohn’s Disease. (AFFIRM), ClinicalTrials.gov ID NCT06063967