Takeda’s Phase 3 KEPLER Trial Shows ENTYVIO Achieves Remission, Demonstrates Efficacy And Safety In Pediatric Ulcerative Colitis

Takeda has announced positive results from its pivotal Phase 3 KEPLER trial evaluating ENTYVIO® (vedolizumab) in children and adolescents aged 2 to 17 with moderately to severely active ulcerative colitis (UC). The findings, presented at the European Crohn’s and Colitis Organisation (ECCO) Congress, demonstrate that vedolizumab may enable clinical remission in a pediatric population with limited treatment options. ENTYVIO is already established as a key therapy for adults with UC, and the KEPLER study expands understanding of its potential use in younger patients.

The trial enrolled 120 pediatric patients who had shown inadequate response to conventional therapies, including corticosteroids, immunomodulators, and/or tumour necrosis factor (TNF) inhibitors. All participants received open-label intravenous vedolizumab during a 14-week induction phase. Among them, 93 patients who achieved a clinical response at Week 14 were randomised to receive either low- or high-dose maintenance treatment every eight weeks.

“Ulcerative colitis is a life-altering diagnosis for young patients and their families, often leaving them searching for effective options. In the KEPLER study, we observed clinically meaningful improvements with vedolizumab in an especially difficult-to-treat patient population, children and adolescents who had failed on the current standard of care, including conventional therapies and/or tumour necrosis factor (TNF) antagonists,” said Ramalingam Arumugam, MD, study investigator and pediatric gastroenterologist at MNGI Digestive Health in Minnesota. “Study data showed nearly half of patients were in remission after one year and safety was generally consistent with vedolizumab’s profile in adults, suggesting that vedolizumab could become important in addressing pediatric UC in those 2 years of age and older.”