Study identifies potential new class of drug for treating ulcerative colitis

August 15, 2012

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 and 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."

One hundred and ninety four patients were part of the randomized trial, which was conducted at 51 centers in 17 countries. Eligible patients were at least 18 years of age, had a confirmed diagnosis of ulcerative colitis and had previously been treated with conventional therapy for the disease.

The patients were treated for eight weeks. They were given a dose of Tofacitinib twice daily, and benefits could be seen as early as two weeks. A flexile sigmoidoscopy was performed at the beginning and end of the trial, along with blood work and stool samples as a measurement of intestinal inflammation.

Among patients treated, the most commonly reported infections were influenza and nasopharyngitis - a respiratory infection with common-cold symptoms. Two patients developed an abscess, and in some cases, headaches were reported and the ulcerative colitis worsened.

"The goal of this study was to show that the oral inhibitor is effective in treating . The next phase of studies aim to confirm the efficacy and safety profile of the drug, will examine the long term or maintenance effect of Tofacitinib and confirm the results of this study," said Sandborn.

Related Stories

Recommended for you

New cellular approach found to control progression of chronic kidney disease

December 15, 2017
Researchers have demonstrated for the first time that extracellular vesicles - tiny protein-filled structures - isolated from amniotic fluid stem cells (AFSCs) can be used to effectively slow the progression of kidney damage ...

Testing shows differences in efficacy of Zika vaccines after one year

December 15, 2017
(Medical Xpress)—A large team of researchers with members from Harvard Medical School, Walter Reed Army Institute of Research, Bioqual Inc. and MIT has found that the efficacy of the three types of Zika vaccines currently ...

How to regulate fecal microbiota transplants

December 15, 2017
(Medical Xpress)—A small team of researchers at the University of Maryland, some with affiliations to the Veterans Affairs Maryland Health Care System, has written and published a Policy Forum piece in the journal Science ...

Screening could catch a quarter of hip fractures before they happen

December 15, 2017
Community screening for osteoporosis could prevent more than a quarter of hip fractures in older women - according to new research led by the University of East Anglia (UEA).

Urine test developed to test for tuberculosis

December 14, 2017
(Medical Xpress)—An international team of researchers has developed a urine test that can be used to detect tuberculosis (TB) in human patients. In their paper published in Science Translational Medicine, the group describes ...

40 years after first Ebola outbreak, survivors show signs they can stave off new infection

December 14, 2017
Survivors of the first known Ebola outbreak, which occurred in the Democratic Republic of the Congo in 1976, may be key to development of vaccines and therapeutic drugs to treat future outbreaks, according to a new study ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.