Infliximab for the Treatment of Fistulas in Patients with Crohn's Disease
Daniel H. Present, M.D., Paul Rutgeerts, M.D., Stephan Targan, M.D., Stephen B. Hanauer, M.D., Lloyd Mayer, M.D., R.A. van Hogezand, M.D., Daniel K. Podolsky, M.D., Bruce E. Sands, M.D., Tanja Braakman, M.D., Kimberly L. DeWoody, Ph.D., Thomas F. Schaible, Ph.D., and Sander J.H. van Deventer, M.D., Ph.D.
Background Enterocutaneous fistulas are a serious complicationof Crohn's disease and are difficult to treat. Infliximab, achimeric monoclonal antibody to tumor necrosis factor , hasrecently been developed as a treatment for Crohn's disease.We conducted a randomized, multicenter, double-blind, placebo-controlledtrial of infliximab for the treatment of fistulas in patientswith Crohn's disease.
Methods The study included 94 adult patients who had drainingabdominal or perianal fistulas of at least three months' durationas a complication of Crohn's disease. Patients were randomlyassigned 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 threewere to be administered intravenously at weeks 0, 2, and 6.The primary end point was a reduction of 50 percent or morefrom base line in the number of draining fistulas observed attwo or more consecutive study visits. A secondary end pointwas the closure of all fistulas.
Results Sixty-eight percent of the patients who received 5 mgof infliximab per kilogram and 56 percent of those who received10 mg per kilogram achieved the primary end point, as comparedwith 26 percent of the patients in the placebo group (P=0.002and P=0.02, respectively). In addition, 55 percent of the patientsassigned to receive 5 mg of infliximab per kilogram and 38 percentof 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 timeduring which the fistulas remained closed was three months.More than 60 percent of patients in all the groups had adverseevents. For patients treated with infliximab, the most commonwere headache, abscess, upper respiratory tract infection, andfatigue.
Conclusions Infliximab is an efficacious treatment for fistulasin patients with Crohn's disease.
Source Information
From Mount Sinai Medical Center, New York (D.H.P., L.M.); University Hospital, Leuven, Belgium (P.R.); Cedars Sinai Medical Center, Los Angeles (S.T.); the University of Chicago, Chicago (S.B.H.); Leiden University Medical Center, Leiden, the Netherlands (R.A.H.); the Gastrointestinal Unit and Center for Inflammatory Bowel Diseases, Massachusetts General Hospital and Harvard Medical School, Boston (D.K.P., B.E.S.); Centocor, Malvern, Pa. (T.B., K.L.D., T.F.S.); and the Academic Medical Center, Amsterdam (S.J.H.D.). Other participants in the study are listed in the Appendix.
Address reprint requests to Dr. Present at 12 E. 86th St., New York, NY 10028-0517.
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Hartmann, G., Bidlingmaier, C., Siegmund, B., Albrich, S., Schulze, J., Tschoep, K., Eigler, A., Lehr, H. A., Endres, S.
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, 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. 
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