The FDA has approved an under-the-skin induction regimen for AbbVie’s Skyrizi, allowing adults with moderately to severely active Crohn’s disease to begin treatment at home using an on-body injector.
The new regimen delivers 720 milligrams at weeks zero, two, four and eight. Maintenance treatment begins at week 12, with doses administered every eight weeks.
Patients retain the option of starting treatment intravenously, receiving 600 milligrams at weeks zero, four and eight before moving to maintenance injections.
The approval was supported by the Phase 3 AFFIRM trial, which compared subcutaneous Skyrizi with placebo in 274 patients. The study met its two primary goals: clinical remission and endoscopic response at week 12.
Overall, 56% of Skyrizi recipients achieved clinical remission, compared with 30% receiving placebo. Endoscopic response occurred in 43% and 15%, respectively. Both differences were statistically significant.
Among patients without prior advanced therapy failure, remission rates were 74% with Skyrizi and 27% with placebo. Endoscopic response rates in that subgroup were 60% and 15%.
The trial also met secondary endpoints for endoscopic remission and fatigue scores. AbbVie said the safety findings were generally consistent with Skyrizi’s established Crohn’s disease profile, with no new risks identified.
Separately, the FDA approved revised tuberculosis precautions across all approved Skyrizi indications. The updated prescribing information advises clinicians to consider tuberculosis evaluation before treatment based on clinical judgment, rather than requiring a test.
The new approval adds another induction route while retaining the existing intravenous treatment option.
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