- The KEPLER Phase 3 study involved 120 pediatric patients with ulcerative colitis.
- Vedolizumab achieved 47.3% clinical remission at 54 weeks.
- Safety profile was consistent with adult use, with no new safety signals.
- Takeda plans to submit marketing applications for ENTYVIO in multiple regions.
Study Overview
The KEPLER Phase 3 study evaluated the efficacy and safety of vedolizumab in pediatric patients aged 2 to 17 with moderately to severely active ulcerative colitis. These patients had previously shown inadequate responses to conventional treatments or TNF antagonists.
Key Findings
Results indicated that 47.3% of the randomized patients achieved clinical remission at 54 weeks. Additionally, 34.7% of patients reached clinical remission at 14 weeks, and 29% maintained remission at both Weeks 14 and 54.
Safety Profile
The safety profile of vedolizumab in the study was consistent with its established profile in adults, with no new safety signals identified. Common treatment-emergent adverse events included upper respiratory infection (30%), worsening ulcerative colitis (17.5%), and pyrexia (12.5%).
Future Plans
Takeda intends to submit marketing applications for intravenous ENTYVIO for treating moderately to severely active ulcerative colitis in children and adolescents in the United States, the European Union, and other markets.
