The recent STELARA FDA approval marks a major milestone for families managing a challenging and chronic gastrointestinal condition. On April 15, 2026, the U.S. Food and Drug Administration (FDA) officially sanctioned STELARA® (ustekinumab) for the treatment of patients two years of age and older dealing with moderately to severely active Crohn’s disease (CD).
Nearly one million people live with Crohn’s disease in the United States, and up to 25% of those individuals are diagnosed during childhood. Pediatric Crohn’s disease is frequently more aggressive than adult-onset CD. It increases the risk of lifelong complications and severe growth impairment during a child’s most critical developmental years.
You can read more about the impact of the condition on children at the Crohn’s & Colitis Foundation. To read more about our ongoing commitment to immune therapies, visit our Immunology Research Updates page.
Learn More: STELARA® (ustekinumab) for Pediatric Crohn’s Disease: Johnson & Johnson Files for FDA Approval
Clinical Data from the Phase 3 UNITI-Jr Study
The STELARA FDA approval was heavily supported by clinical data gathered from the Phase 3 UNITI-Jr study (NCT04673357). This comprehensive 52-week, multicenter, open-label interventional study evaluated the safety, efficacy, and pharmacokinetics of STELARA. The trial was split into an 8-week induction phase and a 44-week maintenance phase.
The adverse reaction profile observed in these pediatric subjects was found to be similar to that reported in adult clinical trials for Crohn’s disease. Below are tables summarizing the clinical safety data regarding common adverse reactions (occurring in at least 10% of pediatric patients) observed during both phases of the trial:
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Adverse Reactions During the Induction Phase (8 Weeks)
| Adverse Reaction | Percentage of Pediatric Patients Affected |
| Upper respiratory tract infection | 13% |
Adverse Reactions During the Maintenance Phase (44 Weeks)
| Adverse Reaction | Percentage of Pediatric Patients Affected |
| Upper respiratory tract infection | 17% |
| COVID-19 | 17% |
| Headache | 10% |
