Vedolizumab’s safety profile was generally consistent with its known safety profile in adults
Takeda, a global pharmaceutical company, has shared encouraging results from the pivotal Phase 3 KEPLER trial, which evaluated ENTYVIO® (vedolizumab) for children and adolescents ages 2 to 17 with moderately to severely active ulcerative colitis. The study demonstrated that vedolizumab may help this young patient population achieve clinical remission, a significant development given the limited treatment options available for pediatric ulcerative colitis. The findings were presented at the 21st Congress of the European Crohn’s and Colitis Organisation, highlighting both the drug’s effectiveness and safety profile in younger patients. ENTYVIO, already a cornerstone therapy for adults with ulcerative colitis, continues to show potential to expand its benefits to children.
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Ramalingam Arumugam, MD, a pediatric gastroenterologist at MNGI Digestive Health and KEPLER study investigator, noted that ulcerative colitis is a challenging condition for children and their families, often leaving them with few treatment alternatives. He explained that the study showed meaningful improvements for patients who had not responded to standard care, including conventional therapies and tumor necrosis factor antagonists. Dr. Arumugam added that nearly half of the patients achieved remission after one year, and the safety profile was consistent with what has been observed in adults, suggesting that vedolizumab could play a key role in treating pediatric patients.
The KEPLER trial enrolled 120 children and adolescents with moderately to severely active ulcerative colitis who had an inadequate response to conventional treatments. Participants received intravenous vedolizumab during a 14-week open-label induction period. Of the 93 patients who achieved a clinical response at Week 14, 47 were randomized to low-dose and 46 to high-dose maintenance therapy every eight weeks. Results showed that 47.3 percent of participants reached clinical remission at Week 54, 34.7 percent achieved remission at Week 14, and 29 percent sustained remission at both Week 14 and Week 54. The safety profile was generally consistent with prior adult studies, with the most common treatment-emergent adverse events being upper respiratory infection, worsening of ulcerative colitis, and fever.
Awny Farajallah, MD, Takeda’s Chief Medical Officer, emphasized that children and adolescents with ulcerative colitis have long faced limited therapeutic choices. He stated that the KEPLER results are promising, reinforcing ENTYVIO’s established role in the treatment of ulcerative colitis and demonstrating potential benefits for patients as young as two years old. Dr. Farajallah added that the findings highlight Takeda’s ongoing commitment to evidence-based care and to supporting vulnerable patient populations in gastroenterology.
Takeda plans to submit marketing applications in the United States, the European Union, and other markets for intravenous ENTYVIO for children and adolescents with moderately to severely active ulcerative colitis.
The KEPLER study was a Phase 3, global, randomized, double-blind, multi-center trial evaluating intravenous vedolizumab in children ages 2 to 17 with inadequate response to steroids, immunomodulators, or tumor necrosis factor antagonists. The study featured a 14-week open-label induction period followed by a 40-week randomized maintenance phase comparing low and high doses based on patient weight. The primary endpoint was clinical remission at Week 54, defined by symptomatic improvement and minimal or no disease activity. Secondary endpoints included safety, sustained remission, endoscopic outcomes, dose escalation for loss of response, and long-term disease control.
The KEPLER results reinforce the potential of ENTYVIO to address the unmet needs of pediatric patients with ulcerative colitis while maintaining a safety profile consistent with adult use.
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