WEDNESDAY, Dec. 7 (HealthDay News) -- Infliximab, a monoclonal antibody against tumor necrosis factor-alpha, is effective in treating ulcerative colitis, according to a report in the Dec. 8 issue of the New England Journal of Medicine.
Paul Rutgeerts, M.D., Ph.D., of University Hospital Gasthuisberg in Leuven, Belgium, and colleagues conducted two randomized, double-blind, placebo-controlled studies -- the Active Ulcerative Colitis Trials 1 and 2 (ACT 1 and ACT 2) -- to evaluate the efficacy of infliximab for induction and maintenance therapy in adults with ulcerative colitis.
In each trial, 364 patients with moderate-to-severe active ulcerative colitis received either a placebo, or infliximab (5 mg or 10 mg per kilogram of body weight) intravenously at weeks 0, 2 and 6, and then every eight weeks through week 46 in ACT 1 and through week 22 in ACT 2.
Patients treated with infliximab had a significant improvement compared with the placebo group at week eight. For ACT 1, 69% of patients receiving 5 mg infliximab and 61% of patients receiving 10 mg infliximab responded, compared with 37% of patients receiving a placebo. For ACT 2, 64% of patients receiving 5 mg and 69% of patients receiving 10 mg responded, compared with 29% receiving a placebo.
"Tumor necrosis factor-alpha plays a role in the disease process and... targeting this cytokine is an effective therapy for ulcerative colitis," the authors conclude.
The study was supported by Centocor and Schering Plough.
Abstract
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