Takeda presents long-term Entyvio data in CD and UC
pharmafile | March 21, 2016 | News story | Manufacturing and Production, Research and Development | Crohn's, Crohn's and Colitis, Entyvio, Takeda, ulcerative colitis
Japan’s Takeda has presented interim findings from the GEMINI Long-Term Safety (LTS) study of ulcerative colitis drug Entyvio (vedolizumab) at the 2016 European Crohn’s and Colitis Organisation (ECCO) meeting in Amsterdam today, showing patients enjoyed clinical improvements with approximately three years of treatment.
Findings from a second analysis of GEMINI LTS were also presented, and mucosal healing was observed in patients with Crohn’s disease (CD) or UC after long-term treatment with Entyvio.
Entyvio was approved as a gut-selective humanized monoclonal antibody in both the European Union and US in 2014. The drug’s approval now extends to 48 countries, across three continents.
Interim data from the open-label extension study GEMINI LTS, where eligible patients received Entyvio every four weeks, were analysed for 73 patients with moderately to severely active UC.
These patients had completed 152 weeks of cumulative treatment with Entyvio, having first received the drug either every eight weeks or every four weeks during the GEMINI I maintenance phase, after demonstrating an initial response at week six to two induction doses.
Remission was observed in 53% and 39% of patients for the eight-week and four-week treatment groups, respectively. Slightly higher remission rates (57% and 43%, respectively) were also observed in patients who were tumour necrosis factor-alpha (TNF) blocker naïve, compared with those who had experienced prior TNF blocker failure (48% and 29%, respectively).
“Interim findings revealed very encouraging levels of remission for patients with ulcerative colitis with approximately three years of treatment and also provided valuable insights about how treatment history may impact treatment success,” says Edward Loftus, Professor of medicine, Gastroenterology, Mayo Clinic.
“Achieving long-term remission is the treatment goal for all patients living with inflammatory bowel diseases, so it is essential that studies like this are conducted to help us understand the long-term efficacy and safety of the treatment options we prescribe.”
“The pivotal Phase III GEMINI clinical trial program was the largest ever conducted simultaneously in ulcerative colitis and Crohn’s disease, and continues to yield a great depth of information around the safety and efficacy of vedolizumab,” adds Dr Michael Smyth, global brand medical director, Gastroenterology, Takeda. “Takeda is committed to studying the long-term efficacy and safety of vedolizumab in order to equip the medical community with the best possible tools and data to address the needs of patients who are impacted with these diseases, which are chronic in nature and require long-term treatment.”
Joel Levy
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