Takeda has reported positive results from the pivotal Phase 3 KEPLER trial evaluating ENTYVIO (vedolizumab) intravenous therapy in children and adolescents aged 2 to 17 years with moderately to severely active ulcerative colitis who had not responded adequately to conventional treatments and/or tumor necrosis factor (TNF) antagonists. The data were presented at the 21st Congress of the European Crohn’s and Colitis Organisation (ECCO).
The global, randomized, double-blind, multicenter study enrolled 120 pediatric patients who all received open-label vedolizumab IV during a 14‑week induction period. Ninety‑three patients who achieved a clinical response at Week 14 were randomized to low‑dose (n=47) or high‑dose (n=46) maintenance therapy every eight weeks for 40 weeks. Nearly half (47.3%) of these randomized participants met the primary endpoint of clinical remission at Week 54, while 34.7% achieved clinical remission at Week 14 and 29% maintained remission at both Weeks 14 and 54.
The safety profile of vedolizumab in KEPLER was generally consistent with its established profile in adults, with no new safety signals observed. The most frequently reported treatment‑emergent adverse events (≥10%) were upper respiratory infection (30%), ulcerative colitis worsening (17.5%), and pyrexia (12.5%). Vedolizumab is currently approved in adults with moderately to severely active ulcerative colitis and Crohn’s disease and is available in more than 80 countries for intravenous use and more than 50 countries for subcutaneous use.
Takeda plans to submit marketing applications in the United States, European Union and other markets seeking approval of intravenous ENTYVIO for children and adolescents aged 2 to 17 years with moderately to severely active ulcerative colitis.
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