AbbVie Reports Phase 3 Results for Subcutaneous SKYRIZI in Crohn's Disease
AbbVie released Phase 3 AFFIRM findings for subcutaneous SKYRIZI as induction therapy in adults with moderate-to-severe Crohn's disease. At week 12, endoscopic remission was 27.7% with the drug versus 10.2% with placebo, and ulcer-free endoscopy was 26.2% versus 10.2%. Week 24 rates among induction responders were 35.8% versus 9.1% and 36.6% versus 9.1%, while the subcutaneous induction regimen remains under regulatory review.
AbbVie's Phase 3 AFFIRM trial assessed an injectable form of risankizumab-rzaa given under the skin to adults with moderate-to-severe Crohn's disease. The company reported that the trial had already met its two main 12-week goals, with the active treatment outperforming placebo.
At 12 weeks, endoscopic remission and ulcer-free endoscopy were roughly two to three times more common with the drug than placebo. At 24 weeks, among induction responders who continued into maintenance, those rates remained higher. Patients without earlier advanced therapy failure showed the strongest 24-week results. Safety findings through 24 weeks showed fewer adverse events than placebo and no new signals. The subcutaneous induction use is still being reviewed by U.S. and European regulators.
If regulators clear subcutaneous SKYRIZI for induction, adults with moderate-to-severe Crohn's disease could gain another treatment option, and clinicians may have more flexibility when planning care. Caregivers and health systems might also feel effects through treatment scheduling, coverage decisions, and cost negotiations. The trial results may shape AbbVie's competitive position in inflammatory bowel disease, but real-world benefit will depend on approval terms, payer access, and how the data compare with existing therapies.