Cure8 news brief
Endoscopic remission (visual healing) is linked to better long-term outcomes in Crohn's disease. An approved subcutaneous induction option could make risankizumab easier to use outside infusion settings.
Adults with Crohn's disease, people considering or using biologics, gastroenterologists, and researchers interested in IL-23 inhibitors and Crohn's disease induction therapies.
This RTTNews piece summarizes AFFIRM, a randomized, double-blind Phase 3 trial of subcutaneous risankizumab for induction in adults with moderate-to-severe Crohn's disease.
At Week 24, the article reports 35.8% endoscopic remission and 36.6% ulcer-free endoscopy with skyrizi versus 9.1% for placebo; higher rates were seen in patients without prior advanced therapy. The trial’s co-primary endpoints previously showed Week 12 superiority for clinical remission and endoscopic response.
Practical takeaway: The story describes endoscopic outcomes (visual healing on endoscopy) rather than new safety or long-term effectiveness data, and it notes the findings were presented at a scientific meeting and are being used to support a regulatory filing for a subcutaneous induction regimen.
This article is a news summary of a Phase 3 trial presentation at a professional meeting; it does not provide full trial methods, safety details, or peer-reviewed publication of the complete dataset. The reported endoscopic measures come from the AFFIRM trial as presented at ACG 2026.
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...
New Phase 3 and long‑term analyses presented at ACG 2026 report that risankizumab and upadacitinib showed disease control in patients with moderate‑to‑severe IBD, including difficult‑to‑treat Crohn’s disease. These...
If you have moderate to severe Crohn’s disease, this study suggests some patients who don’t respond to initial risankizumab induction may still benefit from a longer induction period, including improved symptoms and...
