Takeda recently published interim data showing that Entyvio (vedolizumab) treatment continues to be beneficial for people with ulcerative colitis or Crohn’s disease, whether or not they were treated with TNF-blockers at an earlier date.
The study, “Long-term Efficacy of Vedolizumab for Ulcerative Colitis,” published in the Journal of Crohn’s and Colitis, also shows that patients who got better when Entyvio was dosed once every eight weeks also benefited from the treatment when the dosing was increased to once every four weeks.
Entyvio is an antibody that blocks the actions of the molecule alpha4beta7 in the gut mucosa. Entyvio prevents certain immune cells from infiltrating gut tissues.
The GEMINI LTS clinical trial (NCT00790933) is exploring long-term safety data of Entyvio use. It includes patients who have not been treated with the drug before and patients who completed or dropped out of the earlier studies, GEMINI I (NCT00783718) and GEMINI II (NCT00783692).
The GEMINI LTS trial is ongoing. The published data was collected from May 22, 2009 through June 27, 2013. The trial included 845 patients with ulcerative colitis from whom researchers assessed the treatment’s effectiveness.
At the end of the period, 532 patients were continuing treatment. Among 136 patients who had been followed for 104 weeks, 88% were in remission. Among the 73 patients followed for 152 weeks, 96% were in remission.
For 32 patients who withdrew from the every 8-week dose in GEMINI I before week 52, increased dosing to every four weeks led to remission in 28%. There was no difference between patients who had been treated with TNF-blockers earlier and those who had never been exposed to such drugs. TNF-blocking drugs are often used in more severe cases of inflammatory bowel disease.
In addition, patients reported better health-related quality of life as they continued Entyvio treatment.
“These latest findings, reflecting continuous use of vedolizumab for up to three years, are encouraging and provide additional information about the potential benefit for vedolizumab as a long-term treatment option for people with ulcerative colitis and Crohn’s disease,” Dr. Edward Loftus, professor of medicine at the Mayo Clinic in Rochester, Minnesota and first author of the study, said in a news release.