GEMINI long-term safety study of Entyvio (vedolizumab) shows benefits in ulcerative colitis and Crohn's disease- Takeda

Takeda Pharmaceutical announced interim findings from the ongoing, open-label GEMINI long-term safety (LTS) study of Entyvio (vedolizumab). Data presented from two five-year interim analyses of effectiveness and safety in patients with moderate to severely active ulcerative colitis (UC) and Crohn's disease (CD) indicated that long-term treatment of vedolizumab in responders was associated with long-term clinical response and remission, in addition to health-related quality of life (HRQL) improvements for patients over a five-year period. This interim analysis showed that for the 63 observed patients with moderate to severely active UC, 98% experienced clinical response, and 90% were in clinical remission after five years of continued vedolizumab treatment. For the 61 observed patients with moderate to severely active CD, 95% experienced clinical response and 89% were in clinical remission after five years of continued vedolizumab treatment.

The safety profile was consistent with that previously observed in a three-year interim analysis of the LTS study in patients with moderate to severely active UC and CD. Data were presented during the 12th Congress of European Crohn's and Colitis Organisation (ECCO) in Barcelona, Spain, February 15-18, 2017.