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Crohn's disease treatment shows promise in clinical trial

In an initial clinical trial led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, doctors found that up to 75 percent of people with Crohn's disease responded to an experimental new treatment, and up to 50 percent had long-term remission of symptoms. They report these findings in the Nov. 11 issue of The New England Journal of Medicine.

Crohn's, which affects an estimated 500,000 Americans, is an autoimmune disease that attacks the bowels, causing abdominal pain, cramping, diarrhea and rectal bleeding. In severe cases, damaged bowel sections must be surgically removed.

The new treatment is an antibody designed to disable interleukin-12 (IL-12), an immune system protein involved in inflammation. People with Crohn's produce excess IL-12. Previous studies by NIAID researcher Warren Strober, M.D., linked IL-12 to the cascade of immune system events that leads to the debilitating symptoms of Crohn's disease.

"NIAID researchers have taken advantage of a potential target for preventing, early in the disease process, the devastating inflammation that excess IL-12 seems to trigger. Existing treatments, which often fail, attempt to interrupt inflammation far later in the process," says Anthony S. Fauci, M.D., director of NIAID. "This is the first test of this potential new treatment in people with Crohn's disease, and we are encouraged by the results."

The clinical trial was conducted at 15 centers in the United States, Germany and the Netherlands. Peter Mannon, M.D., and Ivan Fuss, M.D., of NIAID led the study, which enrolled 79 men and women with Crohn's disease. Most study volunteers were randomly assigned to groups where they were injected with either low- or high-dose antibody treatments on one of two possible dosing schedules. The remaining sixteen volunteers received placebo injections.

The treatment consisted of a human antibody genetically modified to attach
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Contact: Linda Joy
ljoy@niaid.nih.gov
301-402-1663
NIH/National Institute of Allergy and Infectious Diseases
10-Nov-2004


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