Cure8 news brief
This expands how risankizumab (an IL-23 inhibitor) can be started for adults with moderate-to-severe Crohn’s disease, allowing fully at-home, self-administered induction. That may make initiation easier and reduce clinic visits for many patients.
Adults with moderately to severely active Crohn’s disease; patients considering or currently on biologic therapy; gastroenterologists and IBD clinicians; caregivers involved in medication administration.
The FDA approved a subcutaneous (SC) induction regimen of risankizumab-rzaa (Skyrizi) for adults with moderately to severely active Crohn’s disease based on phase 3 AFFIRM trial results. The approved SC induction dose is 720 mg delivered via on-body injector (OBI) at weeks 0, 2, 4, and 8, with maintenance beginning at week 12 using the OBI every 8 weeks.
The AFFIRM trial met co-primary endpoints: higher clinical remission and endoscopic response with SC risankizumab versus placebo at week 12. Safety findings were consistent with the known risankizumab profile; labeled warnings include hypersensitivity, infections, and hepatotoxicity, and liver testing is recommended.
A concurrent label change allows clinicians to use clinical judgment to decide on pre-treatment TB evaluation rather than requiring routine TB testing. What changed: patients can now start risankizumab induction at home with a self-administered SC regimen instead of IV-only induction, though IV induction remains an option.
This may increase convenience and reduce the need for clinic visits during induction. Practical notes: the approval and the label update are regulatory facts from AbbVie and the FDA; the AFFIRM trial text provided the efficacy and safety summaries cited by the company.
For people starting therapy, liver testing and awareness of labeled risks are part of the prescribing information; discuss monitoring and TB screening with your clinician.
The summary is based on the HCPLive article reporting AbbVie’s announcement and FDA approval grounded in the phase 3 AFFIRM trial. AFFIRM was a randomized, double-blind, placebo-controlled trial; reported efficacy and safety summaries are from the article and AbbVie. The label update about TB testing leaves the decision to clinical judgment.
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.
This gives adults with moderately to severely active Crohn’s disease a new at-home way to start Skyrizi treatment instead of needing an IV infusion, which can make initiation more convenient and fit into daily life.
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...
A subcutaneous induction option for SKYRIZI could let people with Crohn’s start and continue treatment with injections instead of beginning with an IV infusion, which may affect convenience, time in clinic, and infusion...
