Takeda Pharmaceuticals recently presented positive five-year results of an eight-year clinical trial (NCT00790933) evaluating the long-term safety of Entyvio (vedolizumab) in patients with active ulcerative colitis and Crohn’s disease, two of the most common inflammatory bowel diseases (IBDs).
Interim findings of the GEMINI Phase 3 trial, which began in May 2009 and is expected to be complete in July 2017, indicate that patients responding to long-term treatment with Entyvio exhibited clinical response and remission. Patients also improved their health-related quality of life.
The data was presented at the 12th Congress of European Crohn’s and Colitis Organization (ECCO) Feb. 15-18 in Barcelona, Spain.
Entyvio was approved by the U.S. Food and Drug Administration in 2014 for adults with moderate to severe Crohn’s disease (CD) and ulcerative colitis (UC).
Patients with either Crohn’s disease or ulcerative colitis were evaluated for their clinical response to Entyvio treatment. In CD, clinical response was defined as a reduction in the Harvey-Bradshaw Index of at least 3 points from baseline, and for UC, clinical response was a reduction in the partial Mayo score of at least 2 points and more than a 25% change from baseline. Additionally, patients should exhibit a decrease in rectal bleeding subscore.
Clinical remission was defined in CD patients as a Harvey-Bradshaw Index equal or less than 4, while in UC, clinical remission was defined as a partial Mayo score equal to or less than 2 with no individual subscore higher than 1.
Of the 63 patients with moderate to severely active UC assessed in the analyses, 98% achieved clinical response, and 90% of the patients entered clinical remission after five years of treatment with Entyvio.
Also, among the 61 CD patients with moderate to severely active disease, 95% experienced clinical response, and 89% achieved clinical remission after five years of continued Entyvio treatment.
All participating patients also showed improvements in health-related quality of life determined by the IBD Questionnaire (IBDQ) and Euro Quality of Life-5D visual analogue scale (EQ-5D VAS). Safety analysis of five-year Entyvio treatment showed no new concerns compared to the previous analysis performed after three years of treatment.
“These latest findings underscore the consistent safety profile and effectiveness of vedolizumab [Entyvio] as a long-term treatment option for adults with moderate to severely active ulcerative colitis and Crohn’s disease,” Prof. Dr. Severine Vermeire of the University Hospitals Leuven in Belgium said in a press release.
“It is encouraging that the data continue to show the potential benefit of vedolizumab use for people impacted by one of these two chronic diseases,” he added.