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Jump to Key Points The US FDA has approved the interleukin-12/23 inhibitor Stelara (ustekinumab, Janssen Biotech) for children as young as 2 years of age with moderately to severely active ulcerative colitis (UC).
The FDA approved Stelara for children as young as 2 years with moderate-to-severe Crohn's disease (CD) in April — making it the first approved therapeutic monoclonal antibody that does not target human TNF alpha for the two main forms of pediatric inflammatory bowel disease, the FDA said in a statement.
The safety and effectiveness of Stelara in children with UC was supported by evidence from studies in adults with UC, pharmacokinetic and safety data from children as young as 2 years with CD, as well as additional data from the phase 3 UNIFI Jr study, which enrolled 112 children aged 3-17 years with moderate-to-severe UC.
At week 52 in the UNIFI Jr study, 32 of 79 (40.5%) clinical responders achieved clinical remission and 52 (65.8%) achieved symptomatic remission.
- FDA approved ustekinumab for pediatric UC age ≥2 years.
- Indicated for moderately to severely active ulcerative colitis.
- Approval supported by adult UC data + pediatric CD PK/safety + UNIFI Jr.
- UNIFI Jr: 40.5% clinical remission; 65.8% symptomatic remission at week 52.
- Regimen: IV induction, then SC maintenance; safety similar to adult trials.
Stelara was administered as a single intravenous induction dose followed by subcutaneous maintenance therapy, with a safety profile consistent with that seen in adult trials.
The most common adverse reactions in children with UC receiving Stelara are nasopharyngitis, headache, abdominal pain, influenza, fever, diarrhea, sinusitis, fatigue, and nausea.
Full prescribing information is available online.
