Cure8 news brief
This change may make starting Skyrizi more convenient for adults with Crohn's disease by allowing subcutaneous induction at home using an on‑body injector, rather than requiring clinic IV infusions. It also represents an FDA regulatory update expanding how an already‑approved biologic may be delivered.
Adults with moderately to severely active Crohn's disease; patients considering or using Skyrizi/risankizumab; clinicians who prescribe biologics; researchers and developers of drug delivery devices.
The approval is based on phase 3 AFFIRM, which randomized 274 adults and reported higher week‑12 clinical remission (56% vs 30%) and endoscopic response (43% vs 15%) versus placebo for the subcutaneous OBI induction regimen.
The approved subcutaneous induction is 720 mg delivered by OBI at weeks 0, 2, 4, and 8; IV induction (600 mg at weeks 0, 4, and 8) remains an option. Maintenance with OBI every eight weeks begins at week 12. Label updates also include tuberculosis evaluation guidance and liver monitoring language.
What to watch: The published summary notes that safety conclusions come from the sponsor's report, subgroup sizes (especially advanced‑therapy‑naive patients) were small, and extension/longer‑term data were not reported in the article.
The device presentations listed in the label raise questions about how the 720 mg assembly is administered from available cartridge sizes; the release did not provide manufacturing or supply details.
The efficacy and safety summaries reported in the article are based on AbbVie's AFFIRM phase 3 data and company materials; independent peer‑reviewed publications or longer‑term safety data were not presented in the article. The article notes some subgroup sample sizes were small and that some patient‑reported device satisfaction data come from company surveys.
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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