FDA expands Stelara approval to pediatric Crohn’s disease

FDA has approved Stelara (ustekinumab) for pediatric patients aged two years and older with moderately to severely active Crohn’s disease. The decision represents an expanded indication for the IL‑12/23 antagonist—already established in adult Crohn’s disease.

Up to 25% of Crohn’s disease cases are diagnosed during childhood, when disease severity and complications can impair growth and development. Expanding access to a non‑TNF biologic offers clinicians an additional mechanism of action for pediatric patients who may not respond to or tolerate existing therapies.

In the phase 3 UNITI‑Jr study of 101 pediatric patients with moderately to severely active Crohn’s disease, open‑label IV ustekinumab induction followed by randomized, double‑blind SC ustekinumab maintenance every 8 or 12 weeks demonstrated robust induction and maintenance efficacy. At week 8, 46.5% (47/101) of patients achieved clinical remission while 84.2% achieved a clinical response. Among patients in remission at week 8, 68.1% (32/47) maintained remission through week 52. Across all induction responders, 54.1% achieved clinical remission and 52.9% achieved corticosteroid‑free clinical remission at one year. Remission rates were higher in biologic‑naïve patients and were comparable across weight categories and maintenance dosing schedules (every 8 vs. every 12 weeks), indicating consistent efficacy across key subgroups.

During the induction phase of Crohn’s disease treatment in pediatric patients, the most frequently reported adverse reaction was upper respiratory tract infection (13%). In the maintenance phase, commonly reported adverse reactions included upper respiratory tract infection (17%), COVID‑19 (17%), and headache (10%).

Stelara is the only FDA-approved IL-12/23 antagonist and the first non-TNF biologic to treat adult and pediatric patients two years and older with moderately to severely active Crohn’s disease.

Sources:

Johnson & Johnson. (2026, May 1). Press release. Johnson & Johnson Announces FDA Approval of STELARA® for Pediatric Crohn’s Disease

De Greef, E, et al. (2026, March 10). J Crohns Colitis. Ustekinumab therapy for moderately to severely active pediatric Crohn's disease: UNITI Jr study safety and efficacy results in patients weighing at least 40 kg