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The FDA has expanded approval of risankizumab (Skyrizi) to include a subcutaneous induction regimen for adults with moderate to severe Crohn's disease — meaning patients can now start treatment at home instead of heading to an infusion center. The phase 3 AFFIRM trial showed nearly twice as many patients achieved clinical remission at week 12 compared to placebo, with a strong safety profile to boot.
The FDA has expanded its approval of risankizumab (Skyrizi, AbbVie) to include a subcutaneous induction regimen for adults with moderately to severely active Crohn's disease. Previously, patients had to receive IV induction at a clinical site before transitioning to subcutaneous maintenance therapy. Now, they can start treatment from home using an on-body injector induction pack — a meaningful shift in convenience and access.
The approval was backed by data from the phase 3 AFFIRM trial, which enrolled 289 adults with moderate to severe Crohn's disease. Patients were randomized 2:1 to receive 720 mg subcutaneous risankizumab or placebo at baseline and at weeks 2, 5, and 8. The drug significantly outperformed placebo on both co-primary endpoints at week 12, and results held strong through week 24 in maintenance.
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Why it matters: Requiring IV infusions for induction can be a real barrier — especially for patients in rural areas or those who struggle to access infusion centers. Subcutaneous induction puts the start of treatment in patients' hands, potentially improving early disease control and reducing the risk of surgery or complications down the line.
