AbbVie's under-the-skin Skyrizi induction lifts Crohn's endoscopic remission to 35.8%

AbbVie presented new endoscopic results from AFFIRM, its Phase 3 study of an under-the-skin induction regimen for Skyrizi (risankizumab) in adults with moderately to severely active Crohn's disease, at the American College of Gastroenterology 2026 meeting, announcing them on 13 October ¹. Subcutaneous induction is under review at both the FDA and the European Medicines Agency ¹.

What the trial found

AFFIRM is a global, randomised, double-blind, placebo-controlled study that assigned 289 patients 2:1 to subcutaneous risankizumab or placebo ¹. The population was hard to treat: 65% had already had an inadequate response to advanced therapies, and patients had lived with Crohn's disease for more than seven years on average ¹. AbbVie had already reported that the drug beat placebo on both co-primary endpoints at week 12, clinical remission and endoscopic response ¹.

The new data go further, to endoscopic remission (a central reader's SES-CD score of 4 or less) and ulcer-free endoscopy ¹. At week 12, 27.7% of the risankizumab group reached endoscopic remission against 10.2% on placebo, and 26.2% were ulcer-free against 10.2% ¹. By week 24 the figures were 35.8% for endoscopic remission and 36.6% for ulcer-free endoscopy, against 9.1% for placebo in both cases ¹.

The gap between patient groups is wide. Among patients new to advanced therapy, week 24 endoscopic remission reached 45.1% and ulcer-free endoscopy 49.0%; among those who had failed at least one advanced therapy, the equivalent rates were 30.1% and 28.9% ¹. At week 12, the treatment-experienced group reached 18.5% endoscopic remission, compared with 44.8% in the therapy-naive group ¹.

AbbVie said safety through week 24 matched the known profile of risankizumab, with fewer treatment-emergent adverse events on the drug than on placebo in both induction and maintenance, and no new safety signals ¹.

What it means for the market

The commercial question is the route of induction. Skyrizi is already approved for Crohn's disease, and the filings with the FDA and EMA seek approval for a subcutaneous induction regimen that AbbVie describes as fully patient-administered ¹. If regulators agree, induction would no longer need an intravenous start, which matters to infusion capacity in hospitals and to how payers and health systems set up the pathway. The sources give no decision dates and no pricing.

For prescribers, the split by prior treatment is the more useful part of the dataset. "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," said Millie D. Long of the University of North Carolina at Chapel Hill, AFFIRM's lead investigator ¹. Kori Wallace, AbbVie's global head of immunology clinical development, pointed to outcomes being reached "after induction" ¹. The near halving of response in patients who had already cycled through advanced therapies is the figure competitors in the IL-23 class and health technology assessors are likely to look at hardest.

Caveats

These results come from the company's own announcement of a conference presentation, not a peer-reviewed paper ¹. Results beyond week 12 were measured only in patients who had a clinical response during induction and went on to maintenance, so the week 24 rates describe a selected group rather than everyone randomised ¹. Subgroup comparisons were not presented as formally tested. A 52-week open-label extension, in which all patients receive the approved maintenance treatment, is still part of the study design ¹.