Tofacitinib drug shows promise against moderate-to-severe ulcerative colitis

Published on August 16, 2012 at 5:51 AM · No Comments

An investigational drug currently under FDA review for the treatment of rheumatoid arthritis has now shown positive results in patients with moderate-to-severe ulcerative colitis, according to researchers at the University of California San Diego, School of Medicine. The study will appear in the August 16, 2012 issue of the New England Journal of Medicine (NEJM).

Results from the phase 2 clinical trial showed the drug Tofacitinib achieved clinical response and remission in certain patients suffering from ulcerative colitis - a chronic inflammatory disease of the colon where patients experience painful episodes of rectal bleeding and diarrhea combined with the urgent need to use the restroom.

"Ulcerative colitis causes severe bouts of illness that adversely affect a patient's quality of life at home and work." said William Sandborn, MD, chief of the Division of Gastroenterology at the UC San Diego School of Medicine and director of the Inflammatory Bowel Disease Center at UC San Diego Health System. "Oral treatment with Tofacitinib resulted in improvement and remission in some patients."

Currently, there are limited types of drugs to treat ulcerative colitis. Drugs available are not universally effective and some require intravenous administration.

"This is a whole new class of drug that affects the number of proteins in the immune system that cause this type of inflammatory bowel disease (IBD)," said Sandborn.

There are about 600,000 to 700,000 patients suffering from ulcerative colitis in the United States. Half of these patients experience severe flare ups that in some cases could progress to surgery where the colon is completely removed.

"Patients with a more advanced case of ulcerative colitis need a potent and highly effective therapy," said Sandborn. "The results of our study show Tofacitinib may provide a new approach to attacking this disease."

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