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Background Long-term corticosteroid therapy for Crohn's disease is associated with important types of morbidity, such as osteoporosis. Safe and effective alternative treatments are required. Although a short-term benefit of cyclosporine in active Crohn's disease has been suggested, the long-term safety and efficacy of this treatment have not been established.
Methods We conducted a randomized, double-blind, placebo-controlled evaluation of the effect of 18 months of low-dose cyclosporine treatment on the course of Crohn's disease. Adult patients whose disease had been active within the previous two years were randomly assigned to receive cyclosporine (151 patients) or placebo (154 patients) in addition to their usual therapy. Randomization was stratified according to center and score on the Crohn's Disease Activity Index (193 patients had scores of 150 or less, and 112 had scores greater than 150). The primary outcome measure was clinically important worsening of Crohn's disease, defined as a 100-point increase in the Crohn's Disease Activity Index from the patient's base-line value. Secondary outcomes were the use of prednisone and 5-aminosalicylates, mean score on the Crohn's Disease Activity Index and mean quality-of-life score, and the need for surgery.
Results The condition of more patients worsened with cyclosporine than with placebo (91 of 151, or 60.3 percent, vs. 80 of 154, or 51.9 percent; P = 0.10). The median time to worsening of disease in patients receiving cyclosporine was 338 days, as compared with 492 days in patients receiving placebo (P = 0.25; relative risk, 1.22; 95 percent confidence interval, 0.86 to 1.72). Analyses of the mean Crohn's Disease Activity Index and quality-of-life scores and of the use of prednisone and 5-aminosalicylates also failed to demonstrate benefit.
Conclusions In our patient population, the addition of low-dose cyclosporine to conventional treatment for Crohn's disease did not improve symptoms or reduce requirements for other forms of therapy.
Source Information
From the Department of Medicine, Division of Gastroenterology, University of Alberta, Edmonton (R.N.F.); the Department of Medicine, Division of Gastroenterology, McMaster University, Hamilton, Ont. (E.J.I.); the Department of Medicine, Division of Gastroenterology, Queen's University, Kingston, Ont. (A.G.); the Departments of Medicine (B.G.F., J.W.D.M., B.V.) and Epidemiology and Biostatistics (B.G.F., J.R.), University of Western Ontario, London; the Department of Medicine, Division of Gastroenterology, McGill University, Montreal (D.K.); the Faculty of Medicine, University of Montreal, Montreal (A.A.); the Department of Medicine, Division of Gastroenterology, University of Toronto, Toronto (F.S.); and the Departments of Medicine (A.L., R.G.) and Epidemiology and Community Medicine (A.L.), University of Ottawa, Ottawa, Ont. -- all in Canada. The Canadian Crohn's Relapse Prevention Trial Investigators are listed in the Appendix.
Address reprint requests to Dr. Feagan at 6 OF 11 University Hospital, 339 Windermere Rd., London, ON N6A 5A5, Canada.
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