CHICAGO – Northwestern Memorial Hospital is one of only eight centers in the nation participating in a clinical trial study to evaluate the effectiveness of a new treatment with an antibody product for ulcerative colitis. The antibody product, called visilizumab, is the first antibody therapy that targets severe ulcerative colitis (UC) at its source in hopes of avoiding surgery to remove diseased colon.
UC is an inflammatory bowel disease (IBD) that causes inflammation and ulceration of the mucous membrane that lines the colon and rectum. The most common symptoms are abdominal pain, rectal bleeding and diarrhea. In severe cases, people may have diarrhea 10 to 20 times a day. These patients may become dehydrated, require hospitalization and a blood transfusion.
Of the roughly 400,000 people in the United States who are afflicted with UC, about 20 percent have such severe cases that oral and intravenous steroid treatments fail and the only option left is invasive surgery to remove all or part of the colon. "Visilizumab appears to block processes that lead to inflammation of the colon in patients that have failed treatment with more conventional therapies such as corticosteroids," explains Alan Buchman, M.D., director of the Inflammatory Bowel Disease Center at Northwestern and associate professor of Medicine at Northwestern University's Feinberg School of Medicine.
Patients with UC have problems with T-cells in the lining of their colon. T cells are a specific subtype of white blood cells called lymphocytes that help fight infections. In many UC cases, the T-cells in the lining of the colon may overreact to normal bacteria or proteins in the diet and cause inflammation of the colon. After time, this can lead to severe intestinal damage, including ulcers.
The new therapy – a laboratory-made antibody – binds to and selectively attacks these problematic T cells, preventing them from producing chemicals that cause inflammation, called cytokines, which can damage the colon. "What makes visilizumab different from other biological therapies, is that rather than combating a specific pro-inflammatory cytokine, this medication targets a particular blood cell that produces the cytokine," indicates Dr. Buchman, who heads the study at NMH.
Evidence from a small earlier study showed visilizumab may assist the body in healing itself from the damage inflicted by chronic inflammation. The first human study with visilizumab - in those with severe UC and who were otherwise facing surgery - showed this medication resulted in the majority of participants being free of relapse for up to 12 months. "We are now investigating whether lower doses of visilizumab will provide a similar benefit."
The option this antibody product may offer to patients with severe UC represents a large shift in how the disease may be treated. "It gives us another medical option before resorting to surgically removing the colon, which can be a very devastating surgery for patients," says Dr. Buchman.
The Northwestern research study will be open to participants who are 18-70 years old, have been diagnosed with ulcerative colitis, and who have active disease despite corticosteroid therapy. The study medication will be provided to all qualified study participants at no cost. Individuals who fit the criteria and are interested in participating can call Northwestern Memorial Hospital's physician referral department at 312/926-8400.
Source: Eurekalert & othersLast reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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