Infliximab for the treatment of fistulas in patients with Crohn's disease

Daniel H. Present, Paul Rutgeerts, Stephan Targan, Stephen B. Hanauer, Lloyd Mayer, R. A. Van Hogezand, Daniel K. Podolsky, Bruce E. Sands, Tanja Braakman, Kimberly L. Dewoody, Thomas F. Schaible, Sander J H Van Deventer

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2217 Scopus citations

Abstract

Background Enterocutaneous fistulas are a serious complication of Crohn's disease and are difficult to treat. Infliximab, a chimeric monoclonal antibody to tumor necrosis factor α, has recently been developed as a treatment for Crohn's disease. We conducted a randomized, multicenter, double-blind, placebo-controlled trial of infliximab for the treatment of fistulas in patients with Crohn's disease. Methods The study included 94 adult patients who had draining abdominal or perianal fistulas of at least three months' duration as a complication of Crohn's disease. Patients were randomly assigned to receive one of three treatments: placebo (31 patients), 5 mg of infliximab per kilogram of body weight (31 patients), or 10 mg of infliximab per kilogram (32 patients); all three were to be administered intravenously at weeks 0, 2, and 6. The primary end point was a reduction of 50 percent or more from base line in the number of draining fistulas observed at two or more consecutive study visits. A secondary end point was the closure of all fistulas. Results Sixty-eight percent of the patients who received 5 mg of infliximab per kilogram and 56 percent of those who received 10 mg per kilogram achieved the primary end point, as compared with 26 percent of the patients in the placebo group (P=0.002 and P=0.02, respectively). In addition, 55 percent of the patients assigned to receive 5 mg of infliximab per kilogram and 38 percent of those assigned to 10 mg per kilogram had closure of all fistulas, as compared with 13 percent of the patients assigned to placebo (P=0.001 and P=0.04, respectively). The median length of time during which the fistulas remained closed was three months. More than 60 percent of patients in all the groups had adverse events. For patients treated with infliximab, the most common were headache, abscess, upper respiratory tract infection, and fatigue. Conclusions Infliximab is an efficacious treatment for fistulas in patients with Crohn's disease.

Original languageEnglish (US)
Pages (from-to)1398-1405
Number of pages8
JournalNew England Journal of Medicine
Volume340
Issue number18
DOIs
StatePublished - May 6 1999

ASJC Scopus subject areas

  • Medicine(all)

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    Present, D. H., Rutgeerts, P., Targan, S., Hanauer, S. B., Mayer, L., Van Hogezand, R. A., Podolsky, D. K., Sands, B. E., Braakman, T., Dewoody, K. L., Schaible, T. F., & Van Deventer, S. J. H. (1999). Infliximab for the treatment of fistulas in patients with Crohn's disease. New England Journal of Medicine, 340(18), 1398-1405. https://doi.org/10.1056/NEJM199905063401804