Cure8 news brief
An at-home Skyrizi induction option can make starting risankizumab more convenient and reduce infusion-center visits for many adults with Crohn's disease. The approval is based on a phase 3 trial showing higher short-term remission and endoscopic response versus placebo.
Adults with moderately to severely active Crohn's disease, patients considering or already on biologic therapy, gastroenterologists, and infusion-clinic staff.
The FDA approved a subcutaneous at-home induction schedule of risankizumab given with an on-body injector (720 mg total across induction at weeks 0, 2, 4, 8), followed by maintenance every eight weeks starting at week 12.
AFFIRM was a randomized, double-blind, placebo-controlled phase 3 trial (n=274) where 56% of treated patients reached clinical remission at week 12 versus 30% on placebo; endoscopic response was 43% vs 15%. The trial included many patients who had already failed advanced therapies.
Safety and monitoring information in the article is drawn from AbbVie's summary and the updated prescribing information: clinicians should check liver tests during induction, and consider tuberculosis testing based on clinical judgment.
The article notes AbbVie's conclusion of no new safety signals but also that some safety and satisfaction data come from company sources. Practical points: the IV induction option remains available (600 mg at weeks 0, 4, 8).
The AFFIRM trial compared subcutaneous risankizumab to placebo and did not directly compare at-home subcutaneous induction to IV induction, so the article's data do not show whether one route is more effective than the other.
The article summarizes company-released AFFIRM trial results and AbbVie's statements; some satisfaction and comparator data are company-reported and not independently verified. AFFIRM compared subcutaneous risankizumab to placebo, not directly to IV induction, and reported only 12-week induction outcomes.
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.
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