CAMBRIDGE, Mass. — Takeda said new Phase 3 trial results show that ENTYVIO (vedolizumab) may offer a viable treatment option for children and adolescents with moderate to severe ulcerative colitis, a population with limited approved therapies.
Data from the global Phase 3 KEPLER study found that nearly half of pediatric patients who responded to induction therapy achieved clinical remission after one year of treatment. The results were presented at the 21st Congress of the European Crohn’s and Colitis Organisation.
The KEPLER trial evaluated intravenous vedolizumab in patients ages 2 to 17 with moderately to severely active ulcerative colitis who had not responded adequately to conventional treatments such as steroids and immunomodulators, or to tumor necrosis factor (TNF) antagonists. Of the 120 patients enrolled, 93 who achieved a clinical response during a 14-week open-label induction period were randomized to receive either a low or high maintenance dose of vedolizumab every eight weeks.
Among those randomized patients, 47.3 percent achieved the primary endpoint of clinical remission at Week 54. More than one-third of patients were in remission at Week 14, and 29 percent achieved sustained clinical remission at both Weeks 14 and 54.
Safety findings in the pediatric population were generally consistent with the established safety profile of vedolizumab in adults, according to the company. The most commonly reported treatment-emergent adverse events included upper respiratory infections, worsening ulcerative colitis, and fever. No new safety signals were identified during the study.
“Ulcerative colitis is a life-altering diagnosis for young patients and their families, often leaving them searching for effective options,” said Ramalingam Arumugam, M.D., a study investigator and pediatric gastroenterologist at MNGI Digestive Health in Minnesota. He said the data showed clinically meaningful improvements in a difficult-to-treat population and suggested vedolizumab could become an important option for pediatric patients.
Takeda said the results highlight a potential opportunity to expand the use of ENTYVIO beyond adults, where the therapy is already widely used. The company plans to submit marketing applications in the United States, the European Union, and other markets seeking approval of intravenous ENTYVIO for children and adolescents ages 2 to 17 with moderately to severely active ulcerative colitis.
Ulcerative colitis is a chronic inflammatory disease of the gastrointestinal tract and one of the two most common forms of inflammatory bowel disease. Treatment options for pediatric patients remain more limited than for adults, particularly for those who do not respond to standard therapies.
Takeda said the KEPLER study builds on more than a decade of research into vedolizumab and reflects its ongoing efforts to expand evidence-based treatment options across the full spectrum of inflammatory bowel disease, including younger and more vulnerable patient populations.
