A new study led by Mayo Clinic researchers has found that ulcerative colitis patients had a 41 percent reduction in colectomy after a year when treated with infliximab, according to a study published in the October 2009 issue of Gastroenterology.
Ulcerative colitis, an inflammatory bowel disease (IBD) that causes chronic inflammation of the colon, is characterized by abdominal pain and diarrhea. Like Crohn's disease, another common IBD, ulcerative colitis can be debilitating and often lead to colectomy or surgical removal of the colon.
"Our purpose in this study was to see if the use of infliximab for ulcerative colitis would reduce the need for surgery," says William Sandborn, M.D., a Mayo Clinic gastroenterologist and lead author of the study. "We found that treatment with infliximab reduced the need for colectomy by 41 percent compared to patients treated with placebo."
In this multi-center, international study, 728 patients received placebo or infliximab (5 or 10 mg/kg) for 46 weeks and were monitored for hospitalization or surgical outcomes. Eighty-seven percent (630 of 728) had complete follow-up for the endpoint of whether or not they had colectomy, while the remaining 13 percent (98 of 728) of patients had follow-up for less then a year, with a median follow-up of 6.2 months in these patients. The research showed that treatment with infliximab at 0, 2 and 6 and then every 8 weeks reduced the incidence of colectomy through 54 weeks by 41 percent in outpatients with moderately-to-severe active ulcerative colitis.
The cumulative incidence of colectomy through 54 weeks was 10% for infliximab and 17% for placebo (p=0.02). Compared with placebo, fewer ulcerative colitis-related hospitalizations and surgeries/procedures occurred with infliximab therapy.
"One of the most feared outcomes for ulcerative colitis patients is surgical removal of the colon," says Dr. Sandborn. "Our research hopes to provide other treatment solutions for patients beyond surgery."
Previous research has shown that infliximab therapy induced clinical remission and bowel healing for colitis patients. This new research provides more information and options for patients struggling with this difficult disease, explains Dr. Sandborn.
Infliximab is an artificial antibody that works by blocking tumour necrosis factor alpha (TNF alpha). TNF alpha is a chemical messenger and a key part of the immune reaction. Infliximab blocks the action of TNF alpha by preventing it from binding to its receptor in the cell.
Ulcerative colitis usually affects only the inner lining of the large intestine (colon) and rectum. It usually occurs in a continuous stretch of the colon, unlike Crohn's disease, which occurs in patches anywhere in the digestive tract and often spreads into the deeper layers of affected tissues.
Dr. Sandborn provided consulting services for Centocor during the course of this research and received no personal compensation. Mayo Clinic received reimbursement for the services provided by Dr. Sandborn.
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