August 31, 2026
1 min read
Key takeaways:
- The FDA approved ustekinumab for pediatric patients with moderate to severe ulcerative colitis.
- The non-TNF-targeting monoclonal antibody is now indicated for both pediatric Crohn’s disease and UC.
The FDA has approved Stelara injection for the treatment of moderately to severely active ulcerative colitis in children aged 2 years and older, expanding the drug’s use for both major forms of pediatric IBD.
The decision follows the FDA’s approval of Stelara (ustekinumab, Janssen) in April for children aged 2 years and older with Crohn’s disease. Ustekinumab is the first non-TNF-targeting monoclonal antibody to be approved for both pediatric CD and UC.
The FDA has approved Stelara injection for the treatment of moderately to severely active ulcerative colitis in children aged 2 years and older, expanding the drug’s use for both major forms of pediatric IBD.
The FDA based its decision on pharmacokinetic and safety data from trials of adult patients with UC and pediatric patients aged 2 to 17 years with CD, as well as the 52-week UNIFI Jr. trial of children aged 3 to 17 years with moderately to severely active UC.
That trial included 112 patients (median age, 14 years; 54.5% girls; 60.7% biologic-naive), who received a single induction dose of IV ustekinumab. Seventy-nine children achieved clinical response at week 8.
Of those induction responders, 40.5% achieved clinical remission at week 52, 65.8% were in symptomatic remission and 40.5% experienced endoscopic improvement. In addition, 40.5% were corticosteroid-free for at least 90 days and 36.7% had histologic-endoscopic mucosal improvement.
Nearly half (47.2%) of those without prior biologic failure achieved remission vs. 26.9% with previous biologic failure.
“Ustekinumab induction and maintenance therapy was effective in treating pediatric patients aged 2 to [younger than] 18 years with moderate to severe pediatric UC,” the study authors wrote. “Ustekinumab was well-tolerated with no new safety signals.”
According to the FDA, common side effects of ustekinumab in this patient population include nasopharyngitis, headache, abdominal pain, influenza, fever, diarrhea, sinusitis, fatigue and nausea.
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