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We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com. Back to Healio 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\u2019s 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\u2019s use for both major forms of pediatric IBD. The decision follows the FDA\u2019s approval of Stelara (ustekinumab, Janssen) in April for children aged 2 years and older with Crohn\u2019s 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\u2019s 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. \u201cUstekinumab induction and maintenance therapy was effective in treating pediatric patients aged 2 to [younger than] 18 years with moderate to severe pediatric UC,\u201d the study authors wrote. \u201cUstekinumab was well-tolerated with no new safety signals.\u201d 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. Published by: Ask a clinical question and tap into Healio AI’s knowledge base.
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