Cure8 news brief
A subcutaneous induction option means some adults with moderate–severe Crohn’s disease can begin risankizumab treatment at home rather than needing an IV infusion visit, potentially increasing convenience and access. The label language change on TB testing gives clinicians more flexibility in pre-treatment assessment.
Adults with moderately to severely active Crohn’s disease; patients considering or currently on biologic therapy; gastroenterologists and infusion-center clinicians; IBD nurse specialists and care teams.
AbbVie announced FDA approval of a fully subcutaneous induction regimen for SKYRIZI (risankizumab-rzaa) in adults with moderately to severely active Crohn’s disease, based on Phase 3 AFFIRM trial results.
The approved subcutaneous induction uses an on-body injector (OBI) pack with 720 mg doses at Weeks 0, 2, 4, and 8, allowing patients to start treatment at home and then continue maintenance dosing with an OBI every eight weeks.
The previously available intravenous induction (600 mg at Weeks 0, 4, and 8) remains an option before transitioning to maintenance at Week 12. The FDA also updated SKYRIZI’s prescribing information to advise clinicians to consider TB evaluation based on clinical judgment, removing a prior requirement for mandatory TB testing.
This is a regulatory approval announcement summarizing FDA action and trial-backed efficacy for induction endpoints. The description of dosing and safety-label language comes from AbbVie’s release as reported by RTTNews; patients should discuss with their clinician whether the subcutaneous pathway is appropriate for their individual care.
The article does not provide detailed safety or comparative effectiveness data beyond the AFFIRM trial meeting its co-primary endpoints.
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.
An FDA approval of a subcutaneous induction option for risankizumab means adults with moderate-to-severe Crohn's disease can start treatment at home using an on-body injector, which may make starting therapy more...
An at‑home subcutaneous induction option for Skyrizi could make starting this IL‑23 inhibitor easier for many adults with moderate‑to‑severe Crohn’s disease, reducing the need for clinic infusions and possibly improving...
This change may make starting Skyrizi easier and more convenient by allowing induction to be done at home rather than IV infusions in a clinic. It expands options among IL‑23 p19 inhibitors for people with moderate to...
