FDA Approves Stelara for Pediatric Ulcerative Colitis; Vedolizumab Shows Remission in KEPLER Trial

The U.S. Food and Drug Administration has approved Stelara (ustekinumab) injection for the treatment of moderately to severely active ulcerative colitis (UC) in pediatric patients aged 2 years old and older. Separately, Takeda announced positive data from the pivotal Phase 3 KEPLER trial showing that intravenous ENTYVIO (vedolizumab) achieved clinical remission in nearly half of pediatric patients with moderate-to-severe UC at one year.

Stelara is the first approved therapeutic monoclonal antibody that does not target human tumor necrosis factor alpha (TNFα) for the two main forms of pediatric inflammatory bowel disease. On April 15, 2026, Stelara was approved for the treatment of moderately to severely active Crohn’s disease in pediatric patients aged 2 years old and older. The safety and effectiveness of Stelara for UC was supported by evidence from adequate and well-controlled studies in adult subjects with UC, pharmacokinetic and safety data from pediatric subjects with Crohn’s disease aged 2 to 17 years, and additional safety, efficacy, and pharmacokinetic data from a 52-week study in 112 pediatric subjects with UC aged 3 to 17 years. The most common adverse reactions in pediatric patients with UC receiving Stelara are nasopharyngitis, headache, abdominal pain, influenza, fever, diarrhea, sinusitis, fatigue, and nausea. Stelara received Orphan Drug Designation for this indication, and approval was granted to Janssen Biotech, Inc.

The KEPLER Phase 3 study evaluated intravenous vedolizumab in children and adolescents aged 2 to 17 years with moderate-to-severe UC who had an inadequate response to conventional therapies, including corticosteroids, immunomodulators, and TNF antagonists. The study enrolled 120 treated patients, with 93 randomized to maintenance dosing after demonstrating a clinical response during the induction phase. Of these 93 patients:

• Nearly half (47.3%) achieved the primary endpoint of clinical remission at Week 54.
• More than one-third (34.7%) achieved clinical remission at Week 14.
• Greater than 1 in 4 (29%) attained sustained clinical remission at both Weeks 14 and 54.

Efficacy was observed across treatment-experienced subgroups, including patients previously exposed to TNF antagonists and corticosteroids. The KEPLER trial used a weight-tiered dosing strategy to achieve consistent therapeutic exposure across a broad pediatric age and weight range. The safety profile of vedolizumab in trial participants was generally consistent with its established safety profile in adults, with no new safety signals identified. The most frequently occurring treatment-emergent adverse events (≥10%) reported with vedolizumab in the KEPLER study were upper respiratory infection (30%), ulcerative colitis disease worsening (17.5%), and pyrexia (12.5%).

The results were presented at the 21st Congress of the European Crohn’s and Colitis Organisation (ECCO). Vedolizumab is marketed under the trade name ENTYVIO. Takeda plans to submit marketing applications in the United States, the European Union and other markets for intravenous ENTYVIO for the treatment of moderately to severely active ulcerative colitis in children and adolescents ages 2-17.