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Volume 330:1841-1845 June 30, 1994 Number 26 Next

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ABSTRACT

Background There has been no new effective drug therapy for patients with severe ulcerative colitis since corticosteroids were introduced almost 40 years ago. In an uncontrolled study, 80 percent of 32 patients with active ulcerative colitis refractory to corticosteroid therapy had a response to cyclosporine therapy.

Methods We conducted a randomized, double-blind, controlled trial in which cyclosporine (4 mg per kilogram of body weight per day) or placebo was administered by continuous intravenous infusion to 20 patients with severe ulcerative colitis whose condition had not improved after at least seven days of intravenous corticosteroid therapy. A response to therapy was defined as an improvement in a numerical symptom score (0 indicated no symptoms, and 21 severe symptoms) leading to discharge from the hospital and treatment with oral medications. Failure to respond to therapy resulted in colectomy, but some patients in the placebo group who had no response and no urgent need for surgery were subsequently treated with cyclosporine.

Results Nine of 11 patients (82 percent) treated with cyclosporine had a response within a mean of seven days, as compared with 0 of 9 patients who received placebo (P<0.001). The mean clinical-activity score fell from 13 to 6 in the cyclosporine group, as compared with a decrease from 14 to 13 in the placebo group. All five patients in the placebo group who later received cyclosporine therapy had a response.

Conclusions Intravenous cyclosporine therapy is rapidly effective for patients with severe corticosteroid-resistant ulcerative colitis.

Source Information

From the Department of Medicine, Division of Gastroenterology (S.L., D.H.P., A.K.), and the Department of Surgery (I.G., J.B.), Mt. Sinai School of Medicine, New York; and the Department of Medicine, Division of Gastroenterology (G.G., S.H.), and the Department of Surgery (F.M.), University of Chicago Medical Center, Chicago.

Address reprint requests to Dr. Lichtiger at 1185 Park Ave., New York, NY 10128.

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