Cure8 news brief
Positive phase 3 results for a subcutaneous risankizumab induction regimen may expand access to an IL‑23 p19 therapy option that avoids IV induction and showed strong short-term remission and endoscopic response rates in this study.
Adults with moderate-to-severe Crohn's disease, patients considering biologic/advanced therapy, clinicians who treat IBD, and researchers following IL-23–targeting drugs.
The AFFIRM study enrolled adults with moderate-to-severe Crohn’s disease (CDAI 220–450) who had prior intolerance or inadequate response to conventional therapies; about a third had prior advanced therapy and many had inadequate response to advanced therapy.
Participants received 720 mg subcutaneous risankizumab at baseline and at weeks 2, 4 and 8, with continued blinded maintenance dosing for responders at weeks 12 and 20. At the prespecified week 12 primary endpoints, risankizumab showed significantly higher rates of clinical remission and endoscopic response compared with placebo.
Week 24 rates of remission and endoscopic outcomes were reported as numerically higher in the treatment arm; safety and adverse event rates were similar between groups and consistent with the drug’s established profile.
This Healio report summarizes a presentation at the ACG Annual Meeting and cites investigator comments; full peer-reviewed publication or regulatory updates were not included in the article.
This article summarizes a conference presentation (ACG Annual Meeting) and not a peer-reviewed full publication. The study population included many patients with prior treatment failure, and while week 12 results were statistically significant, week 24 results were reported as numerical improvements.
Regulatory labeling currently specifies IV induction for risankizumab; this trial tested a subcutaneous induction strategy.
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.
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.
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...
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...
