By VETTAPHARMA reporter: Takeda Pharmaceutical Company Limited released positive Phase III data from its KEPLER trial of ENTYVIO® (vedolizumab) in pediatric patients with moderately to severely active ulcerative colitis (UC), showing nearly half of evaluable patients achieved clinical remission at one year of treatment. The findings, presented at the 21st Congress of the European Crohn’s and Colitis Organization (ECCO), support potential label expansion of the biologic for children and adolescents aged 2–17 years.
The KEPLER study enrolled 120 pediatric patients whose disease remained active despite prior therapies. After a 14-week induction period with intravenous vedolizumab, 93 participants who responded were randomized into maintenance dosing cohorts. At Week 54, 47.3% of those randomized achieved the trial’s primary endpoint of sustained clinical remission. Secondary endpoints included 34.7% remission at Week 14 and 29% sustained remission at both Week 14 and Week 54.
Safety outcomes in the pediatric population were consistent with ENTYVIO’s established adult profile. No new safety signals emerged. The most frequent treatment-emergent adverse events (≥10%) reported were upper respiratory infection (30%), worsening of UC (17.5%), and pyrexia (12.5%).
In commentary accompanying the data release, investigators emphasized the clinical relevance of remission rates in a population with limited treatment options. Study leaders noted that remission at one-year underscores ENTYVIO’s potential to address unmet needs in pediatric UC.
Takeda plans to advance regulatory submissions in the United States, European Union, and other regions for intravenous ENTYVIO in pediatric UC, pending review by health authorities.
Source credit:
- Takeda Pharmaceutical Company Limited. (2026). Takeda highlights positive ENTYVIO® Phase 3 pediatric data at ECCO Congress showing sustained remission and potential expanded use in ulcerative colitis. Click here
