Oral mesalamine (Pentasa) as maintenance treatment in Crohn's disease: A multicenter placebo-controlled study

Abstract

Background: Mesalamine provides a new therapeutic approach in treating Crohn's disease. Methods: To assess the efficacy and safety of slow-release mesalamine (Pentasa; Ferring AS, Vanløse, Denmark) in maintaining remission in Crohn's disease, 161 patients with inactive disease were randomized to receive either Pentasa (2 g/day) or placebo in a 2-year double-blind, multicenter trial. Two strata were defined according to the duration of their remission: <3 months (n = 64) or 3-24 months (n = 97), presumed to be high and a low relapse risk strata, respectively. Results: The probability of relapse was higher in the short-remission placebo group than in the three other groups (P < 0.003), showing there was a significant benefit from Pentasa in the high relapse risk stratum. In this stratum, the 2-year ongoing remission rate was of 29% ± 9% and 45% ± 11% (mean ± SD) in the placebo and Pentasa groups, respectively. The incidences of side effects were similar in both groups. Conclusions: Pentasa (2 g/day for 2 years) is a safe and effective maintenance treatment for Crohn's disease when given within 3 months of achieving remission. © 1993.