Five year data show 95%-plus clinical response in UC, CD for Entyvio

Japanese drug major Takeda Pharmaceutical (TYO: 4502) has presented positive interim findings from the ongoing, open-label GEMINI long-term safety (LTS) study at the 12th Congress of European Crohn's and Colitis Organization (ECCO) in Barcelona, Spain, February 15-18, 2017.

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 (which Takeda markets und the trade name Entyvio) 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.

The LTS study is an ongoing open-label prospective study investigating the long-term safety of vedolizumab in moderate to severely active inflammatory bowel disease (IBD). 146 patients with CD were enrolled from GEMINI II and 154 patients with UC were enrolled from GEMINI I. This interim analysis reports clinical effectiveness evaluated at five years. 58 patients with CD and 54 patients with UC had discontinued therapy before the data cut-off, (11 [19%] and 19 [35%] patients discontinuing respectively due to lack of benefit). 27 CD patients and 37 UC patients had not reached the five year assessment time point in the study.61 patients with CD and 63 patients with UC were evaluated in the analysis.