Takeda has presented data from a post-hoc analysis showing signs of early symptomatic improvement in patients with ulcerative colitis or Crohn’s disease taking Entyvio.
In two post-hoc analyses of data from the Phase III GEMINI trial, presented at the World Congress of Gastroenterology (WCOG) in Orlando, Florida, in patients with UC and CD symptomatic improvements were evaluated with Entyvio (vedolizumab) at weeks 2, 4 and 6, specifically in Mayo Clinic subscores of rectal bleeding and stool frequency in UC, and patient-reported outcome subscores in CD such as abdominal pain and number of liquid or very soft stools.
In patients who reported improvements, the greatest differences from placebo were observed in biologic-naïve patients versus the overall treatment group, some as early as week 2, the firm noted.
“The resolution of patient-reported symptoms for both ulcerative colitis and Crohn’s disease examined in these analyses signifies important treatment goals for patients and key indicators for response to treatment for physicians,” noted Brian Feagan director of Robarts Clinical Trials at Robarts Research Institute, Western University, London, Ontario, Canada, and lead author of both abstracts.
“The results support Entyvio’s value as a therapy for ulcerative colitis and Crohn’s disease with a recognised safety profile and short-and long-term efficacy”.
Enytvio is a novel alpha-4 beta-7 integrin antagonist with a different mode of action to other therapies in that it suppresses immune activity only in the gut as opposed to across the whole body, which experts see as “a step change” in the management of the condition.
The data “underscore the efficacy of Entyvio and its importance as an option for early symptomatic improvement in ulcerative colitis and Crohn’s disease treatment after other treatments fail, particularly in those patients who have not yet received a biologic,” Feagan added.