Cure8 news brief
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.
The decision is supported by phase 3 AFFIRM trial results showing improved short-term remission and endoscopic response versus placebo.
Adults with Crohn’s disease considering biologic therapy, patients already using or considering Skyrizi, gastroenterologists and infusion/clinic staff, and clinicians counseling on induction options.
This FDA decision changes how Skyrizi treatment can be started (subcutaneous OBI induction at home) rather than who is eligible — it does not broaden or narrow the labeled patient population. The approved subcutaneous induction dose is 720 mg via the OBI induction pack at weeks 0, 2, 4, and 8; maintenance begins at week 12 with OBI every eight weeks.
The AFFIRM trial showed higher remission and endoscopic response rates at week 12 for the overall population and larger effects in patients who were advanced-therapy–naive; subgroup sizes were smaller and p-values reported apply to the total population.
Practical points: the FDA also updated labeling across indications to suggest clinicians consider tuberculosis evaluation based on judgment (no mandatory testing) and retained liver monitoring guidance for Crohn’s disease. The safety summary reported in the announcement is company-reported and extension data were not provided in this release.
Results and safety statements in the article rely on the sponsor’s (AbbVie) reporting of AFFIRM; subgroup findings were based on smaller numbers and p-values were reported for the total population. The approval changes the induction route but does not remove the IV induction option. Label updates recommend clinician judgment for TB evaluation and keep liver monitoring guidance.
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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