Cure8 news brief
New Phase 3 data suggest subcutaneous risankizumab (Skyrizi) can achieve meaningful endoscopic remission and ulcer-free endoscopy rates in adults with active Crohn's disease, including higher responses in patients without prior advanced therapy — results that could affect treatment options if regulators approve the subcutaneous regimen.
Adults with Crohn's disease (especially those considering biologic options), patients currently on or considering biologic therapy, gastroenterologists, and IBD researchers.
AbbVie presented AFFIRM Phase 3 data indicating that subcutaneous risankizumab produced higher rates of endoscopic remission and ulcer-free endoscopy than placebo at Week 12 and Week 24; Week 24 endoscopic remission was reported as 35.8% with skyrizi versus 9.1% for placebo.
The analysis included adults who responded in induction and entered maintenance; safety through Week 24 was described as consistent with the established profile and no new safety signals were identified.
The company noted higher Week 24 remission and ulcer-free rates in patients who had not previously received advanced therapies (reported as 45.1% and 49.0%, respectively). The subcutaneous induction regimen is under regulatory review by the FDA and EMA.
Keep reading the original presentation or peer-reviewed publications for full methods and detailed safety data before drawing conclusions for individual treatment decisions.
Data were presented at a conference (ACG 2026) and reported by a business/medical news outlet. The article summarizes company-reported Phase 3 AFFIRM trial results; consult the full conference presentation or peer-reviewed publication for complete trial design, statistical analysis, and safety details.
The subcutaneous regimen is under regulatory review — not yet an approved label change at the time of reporting.
Review the original publication for the complete reporting, methods, and context.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
A new subcutaneous option for risankizumab (SKYRIZI) showed higher rates of endoscopic remission and ulcer-free endoscopy versus placebo in a Phase 3 Crohn's disease trial, which could expand at-home biologic options if...
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