Entyvio (vedolizumab) alleviated some of the early symptoms of patients with moderate to severe ulcerative colitis and Crohn’s disease, a new analysis of Phase 3 trial results indicates.
Takeda Pharmaceutical presented the additional findings of the GEMINI clinical trial program, which covered 2,400 patients, at the World Congress of Gastroenterology in Orlando, Oct. 13-18.
Two ulcerative colitis improvements that one poster presentation focused on were less rectal bleeding and fewer trips to the toilet to defecate — both indicators of remission. The title of the presentation was “Vedolizumab Demonstrates Early Symptomatic Improvement in Ulcerative Colitis: A GEMINI 1 Post hoc Analysis.”
Researchers randomly assigned patients with active ulcerative colitis to receive either Entyvio or a placebo at the start of the six-week trial and in the second week. The team assessed patients’ rectal bleeding and stool frequency at the start of the study and weeks 2, 4, and 6. They used Mayo Clinic rating scales for the symptoms.
The team paid particular attention to the symptoms in patients who had not been treated with a tumor necrosis factor antagonist. A TNF antagonist prevents the cytokine TNF from promoting inflammation and pain.
There was less rectal bleeding and stool frequency among Entyvio-treated patients than in the placebo group, researchers reported. The most significant improvements were seen in those who had never been treated with a TNF antagonist.
A second poster presentation dealt with Crohn’s disease patients’ response to Entyvio. It was titled “Vedolizumab Demonstrates Early Symptomatic Improvement in Crohn’s Disease (CD): A GEMINI 2 Post hoc Analysis.”
Researchers randomized patients to receive either Entyvio a placebo at the start of the six-week trial and at week 2. They evaluated changes in patients’ abdominal pain and number of liquid or very soft stools at the start of the study and at weeks 2, 4, and 6.
“Symptomatic improvements were achieved with vedolizumab as early as week 2,” the researchers wrote. As with the ulcerative colitis study, the biggest differences were seen in those who had never been treated with a TNF antagonist.
“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,” Dr. Brian Feagan, the lead author of both poster studies, said in a press release. “The results support Entyvio’s value as a therapy for ulcerative colitis and Crohn’s disease with a recognized safety profile and short-and long-term efficacy.”
“These post-hoc analyses from the GEMINI clinical trial program 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,” added Feagan, the director of clinical trials at the Robarts Research Institute at Western University in London, Canada.
“While patients require lifelong disease management, Takeda’s presentation of data evaluating early improvement in symptoms for those receiving Entyvio provides valuable clinical knowledge for the IBD community regarding treatment expectations,” said Dr. Karen Lasch, who heads the gastrointestinal therapy program at Takeda’s U.S. operation. “Takeda remains committed to contributing to research that helps patients and providers make informed treatment decisions and achieve treatment goals.”