Cure8 news brief
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 regulators approve the induction regimen.
Adult Crohn's disease patients (including those new to advanced therapies and those who have tried prior biologics), gastroenterologists, and researchers tracking IL-23 inhibitors and administration-route developments.
This is a Phase 3 randomized, placebo-controlled study (AFFIRM) testing a subcutaneous dosing option of risankizumab for induction and maintenance in adults with moderate-to-severe Crohn's disease.
Reported week 12 and week 24 results showed higher percentages of patients achieving endoscopic remission and absence of ulcers with SKYRIZI compared with placebo, including higher rates in patients who were advanced-therapy naïve. Safety through 24 weeks was described as consistent with the known profile of risankizumab and without new safety signals.
These results are relevant because endoscopic healing is an objective measure of mucosal inflammation and is increasingly used as an important treatment goal beyond symptom control.
Data come from a company press release reporting Phase 3 AFFIRM results presented at the ACG 2026 meeting; peer-reviewed publication and regulatory review outcomes are pending. Endoscopic endpoints were centrally read; safety was summarized through 24 weeks as consistent with the known risankizumab profile.
Review the original publication for the complete reporting, methods, and context.
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