Vedolizumab may offer a new hope for people with mild to severe inflammatory bowel disease now that two large clinical trials have demonstrated the drug’s effectiveness against both Crohn’s disease and ulcerative colitis.
Few treatment options exist for the millions of people across the world with Crohn’s disease and ulcerative colitis. Both conditions are autoimmune diseases that are triggered when the immune system runs amok, either due to exposure to microbes or an environmental substance, and begins harming a person’s healthy digestive tissue.
"Inflammatory bowel disease causes severe ongoing bouts of illness that adversely affect a patient's quality of life at home and work," said Dr. William Sandborn, lead author of the Crohn's study and director of the Inflammatory Bowel Disease Center at the University of California San Diego.
"These latest findings will potentially lead to a new drug therapy that will improve a patient's overall lifestyle."
In 1,000-person, year-long trial for Crohn’s disease, about twice as many patients — 39 percent — went into clinical remission using vedolizumab versus 21 percent in the placebo group. The drug was intravenously administered once every two months.
The results were even better for the 900-patient trial for ulcerative colitis, with 41 percent going into remission with the drug versus 15 percent with placebo.
Vedolizumab works like roadblock by blocking the transit of specific immune cells — leukocytes — that are trying to access the digestive tract and cause inflammation. The leukocytes are still allowed access to other parts of the body, unlike in many of the current treatments, meaning vedolizumab should, in theory, display fewer side effects.
One of the most common side effects with some current therapies is PML — or progressive multifocal leukoencephalopathy — which is caused by the opportunistic JC virus. This microbe is carried by most people and is usually harmless, but takes advantage in patients with drug-weakened immune systems.
None of the 1,900 patients in both trials developed PML. The rate of adverse events, such as headaches, nausea, fatigure, was similar between placebo and vedolizumab groups, although a higher percentage of runny noses was noted in the Crohn’s report.
Both investigations were part of the GEMINI study, a 15-year collaborative project involving hospitals in 40 nations and 2,700 patients.
"The publication of these study findings are important since the results support the potential for vedolizumab, if approved, to help manage symptoms in some patients for whom previous treatments have failed," said Dr. Brian Feagan, head of the ulcerative colitis study.
"The data from the GEMINI program suggest that vedolizumab may provide people living with Crohn’s disease and ulcerative colitis an additional option for inducing and maintaining clinical remission," Feagan continued.
Takeda Pharmaceuticals, which developed vedolizumab and funded the trial, has applied to the U.S. Food and Drug Administration and the European Medicines Agency for approval to treat patients with moderate to severe versions of both inflammatory bowel diseases.
Sources: Sandborn WJ, Feagan BG, Paul Rutgeerts P, et al. Vedolizumab as Induction and Maintenance Therapy for Crohn’s Disease. The New England Journal of Medicine. 2013.
Feagan BG, Rutgeerts P, Sands BE, et al. Vedolizumab as Induction and Maintenance Therapy for Ulcerative Colitis. The New England Journal of Medicine. 2013.