Mount Sinai Researchers Examine a New Antibody Used to Treat Both Ulcerative Colitis and Crohn's Disease

The new findings appeared in the New England Journal of Medicine on August 22.

New York
 – September 3, 2013 /Press Release/  –– 

Researchers from the Icahn School of Medicine at Mount Sinai recently published two manuscripts in the New England Journal of Medicine regarding a new antibody used to treat both ulcerative colitis and Crohn’s disease. The journal published these findings on August 22.

Bruce Sands, MD, Professor of Medicine, Gastroenterology and Chief of the Henry D. Janowitz Division of Gastroenterology and Jean-Frédéric Colombel, MD, Director of The Leona M. and Harry B. Helmsley Charitable Trust Inflammatory Bowel Disease Center, led the team of researchers at Mount Sinai. In the first study they observed the intravenous use of the new therapy, named vedolizumab, in adults with active Crohn's disease. In beginning of the trial, 368 patients were randomly assigned to receive vedolizumab or placebo at weeks zero and two.  During the same time frame, 747 patients received an open-label vedolizumab. Disease status was assessed at week six for all patients. After the six weeks, 461 patients who had had a response to vedolizumab were randomly assigned to receive placebo or vedolizumab every eight or four weeks for the remainder of the year-long trial.

"We discovered that the patients with active Crohn's disease that were treated with vedolizumab were more likely than patients receiving placebo to have a remission with a Crohn’s disease activity index (CDAI) <150 but not a (CDAI) 100 response at six weeks" said Dr. Sands. . The patients with a response to the initial therapy who continued to receive vedolizumab, rather than switching to placebo, were more likely to be in remission after the year-long trial."

In the second study, the researchers conducted two randomized, double-blind, placebo-controlled trials of vedolizumab in patients with active ulcerative colitis. Initially, 374 patients received either vedolizumab or placebo intravenously at weeks zero and two, with an evaluation after six weeks. Additionally, 521 patients received open-label vedolizumab therapy during the same time period. Week six responders from both groups were randomized to continue vedolizumab every eight or four weeks or switch to placebo for up to a year.

The response rate after six weeks was nearly 50 percent for the vedolizumab treatment while only 25 percent for the placebo group. At one year, 42 percent and 45 percent of patients randomized to continue vedolizumab every eight weeks or every four weeks, respectively, were in clinical remission as compared with 15.9 percent with placebo.

"We found that treatment with vedolizumab was more effective than placebo during the initial and maintenance therapy for ulcerative colitis," said Dr. Colombel. "The drug was generally well tolerated with a slightly increased rate of side effects especially infections in Crohn’s disease patients treated with vedolizumab as compared to placebo."

About The Mount Sinai Medical Center
The Mount Sinai Medical Center encompasses both The Mount Sinai Hospital and Icahn School of Medicine at Mount Sinai. Established in 1968, the Icahn School of Medicine is one of the leading medical schools in the United States, with more than 3,400 faculty in 32 departments and 14 research institutes. It ranks among the top 20 medical schools both in National Institutes of Health (NIH) funding and by U.S. News & World Report. The Mount Sinai Hospital, founded in 1852, is a 1,171-bed tertiary- and quaternary-care teaching facility and one of the nation’s oldest, largest and most-respected voluntary hospitals. The Mount Sinai Hospital is nationally ranked by U.S. News & World Report as one of the top 25 hospitals in 7 specialties based on reputation, safety, and other patient-care factors.

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