FDA lets Crohn's patients start Skyrizi at home with injections instead of IV infusions

The US Food and Drug Administration on 23 October 2026 approved a subcutaneous (under-the-skin) induction regimen of Skyrizi (risankizumab-rzaa) from AbbVie for adults with moderately to severely active Crohn’s disease, the company announced.

What changes

Until now, starting Skyrizi for Crohn’s required intravenous infusions. Patients can now begin at home with 720 mg delivered by a wearable on-body injector at weeks 0, 2, 4 and 8, then continue with the same device every eight weeks. The IV start (600 mg at weeks 0, 4 and 8) remains available. Skyrizi blocks the inflammatory signalling protein IL-23.

The evidence: AFFIRM

• AFFIRM was a phase 3, randomised, double-blind, placebo-controlled trial in 274 adults (2:1 drug to placebo); 65% had already failed advanced therapies.
• At week 12, according to AbbVie, 56% on Skyrizi were in clinical remission vs 30% on placebo, and 43% vs 15% had an endoscopic response.
• Results were strongest in patients new to advanced therapy (74% vs 27% remission) and weaker in those who had failed biologics or JAK inhibitors (45% vs 31%).
• AbbVie reports no new safety risks. The FDA also updated the label so doctors can use clinical judgment on whether tuberculosis testing is needed before treatment.

Limitations

The figures come from AbbVie’s announcement and the label, not a peer-reviewed publication we could review, and the placebo-controlled phase lasted only 12 weeks. Subgroup comparisons involve small numbers (for example 65 vs 33 treatment-naïve patients), and long-term comparisons with IV induction or other drugs are not available. Treatment choices should be discussed with a gastroenterologist.