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Study shows drug can heal, reduce recurrence of fistulas in Crohn's disease

An international study has found that maintenance therapy with the drug infliximab, a monoclonal antibody used to treat Crohn's disease, can prevent or delay the recurrence of fistulas, a common complication of that inflammatory bowel disorder. As reported in the February 26 New England Journal of Medicine, patients receiving infliximab on a regular basis were twice as likely to avoid fistula recurrence than were patients receiving a placebo.

The study was largely supported by the pharmaceutical firm Centocor, a subsidiary of Johnson & Johnson, which markets infliximab under the brand name Remicade.

Crohn's disease is a chronic inflammatory disorder of the digestive tract that affects about half a million people in the U.S. Patients with more severe symptoms may develop fistulas openings from affected areas of the intestine into other organs or onto the skin, often around the anus. The presence of fistulas can seriously impact patients' quality of life and increases the likelihood of surgical treatment, which may not have satisfactory results. Infliximab, which targets the inflammatory protein tumor necrosis factor, has been shown in previous research to reduce symptoms in patients without this complication and to heal fistulas over a limited period of time.

"Fistulas can be a devastating complication of Crohn's disease," says Bruce Sands, MD, of the Massachusetts General Hospital (MGH) Gastrointestinal Unit, lead author of the report. "While neither medical nor surgical therapy is perfect in treating this complication, our study has shown that maintenance treatment with infliximab can produce durable closure of fistulas in many patients."

The current study carried out at 45 sites in North America, Europe and Israel enrolled adult patients with fistulizing Crohn's disease not previously treated with infliximab. Almost 300 participants completed a preliminary phase of treatment, receiving three intravenous doses of infliximab
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Contact: Sue McGreevey
smcgreevey@partners.org
617-724-2764
Massachusetts General Hospital
25-Feb-2004


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