FDA Approves Stelara for Pediatric Ulcerative Colitis

The FDA approved ustekinumab (Stelara) for moderately to severely active ulcerative colitis (UC) in pediatric patients 2 years of age and older. The approval builds on an existing pediatric indication for Crohn disease (CD), cleared earlier in 2026, making ustekinumab the first therapeutic monoclonal antibody that does not target TNFα approved for both major forms of pediatric IBD.¹

Trial Data and Safety Findings

The FDA based its decision on evidence from adequate and well-controlled studies of ustekinumab in adults with UC, together with pharmacokinetic and safety data from pediatric patients with CD aged 2 to 17 years.¹

Additional efficacy, safety, and pharmacokinetic data came from a 52-week study of 112 pediatric patients with UC aged 3 to 17 years.¹

The most frequently reported adverse reactions among pediatric patients with UC included nasopharyngitis, headache, abdominal pain, influenza, fever, diarrhea, sinusitis, fatigue, and nausea.¹

Understanding Pediatric Ulcerative Colitis

UC is a lifelong condition that causes inflammation and ulcers inside the colon, and it ranks as 1 of the 2 most common forms of inflammatory bowel disease (IBD) alongside CD.² UC is confined to the colon, whereas CD typically affects the small intestine and colon but can involve other portions of the gastrointestinal tract.³

UC affects up to 1 in 250 people in North America and Europe, with an estimated 900,000 people living with the condition in the United States, according to Cleveland Clinic.² The Children's Hospital of Philadelphia (CHOP) notes that although most patients are diagnosed in their mid-30s, the condition is becoming increasingly common in children, and it affects male and female patients equally.⁴

In children, common symptoms include bloody diarrhea, abdominal pain, urgent bowel movements, poor appetite, weight loss, and fatigue. Further, some children also experience skin rashes or joint pain. The disease follows a chronic pattern of flares and remission and can significantly affect a child's quality of life, which is why CHOP's multidisciplinary care team includes psychologists and social workers for long-term management.⁴

Pediatric IBD diagnoses have continued to climb more broadly. Children younger than 18 years account for 20% to 25% of patients who present with IBD, and the incidence of CD alone among children ranges from 2.5 to 11.4 cases per 100,000, according to a 2018 review published in Clinics in Colon and Rectal Surgery.⁵

What the Approval Means for Pharmacists

Before this approval, standard management of UC spanned aminosalicylates, corticosteroids, immunosuppressants, biologics, and JAK inhibitors, with roughly 30% of patients eventually requiring surgery such as proctocolectomy with an ileal pouch or ileostomy.²

CHOP's pediatric protocol layers medication, nutrition support, and surgery, noting that procedures such as J-pouch reconstruction or bowel resection can offer children long-term relief from UC, a durability not typically seen with surgery for CD.⁴

For pharmacists, the ustekinumab expansion adds a nonTNF biologic option earlier in the treatment algorithm for young patients with UC, alongside its established role in pediatric CD. Community and specialty pharmacists counseling these families should be prepared to discuss the reported adverse reaction profile, including gastrointestinal effects such as abdominal pain, diarrhea, and nausea, along with infection-related effects such as nasopharyngitis, influenza, and sinusitis.¹

REFERENCES

1. US Food and Drug Administration. FDA approves Stelara for pediatric ulcerative colitis. FDA. August 28, 2026. Accessed August 31, 2026. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-stelara-pediatric-ulcerative-colitis

2. Cleveland Clinic. Ulcerative colitis. Cleveland Clinic. Accessed August 31, 2026. https://my.clevelandclinic.org/health/diseases/10351-ulcerative-colitis

3. Yale Medicine. Pediatric Crohn's disease. Yale Medicine. Accessed August 31, 2026. https://www.yalemedicine.org/conditions/pediatric-crohns-disease

4. Children's Hospital of Philadelphia. Ulcerative colitis in children. CHOP. Accessed August 31, 2026. https://www.chop.edu/conditions-diseases/ulcerative-colitis-in-children

5. von Allmen D. Pediatric Crohn's Disease. Clin Colon Rectal Surg. 2018;31(2):80-88. doi:10.1055/s-0037-1609022