ORAL MESALAMINE (PENTASA) AS MAINTENANCE TREATMENT IN CROHNS-DISEASE - A MULTICENTER PLACEBO-CONTROLLED STUDY

Background.- Mesalamine provides a new therapeutic approach in treatin g Crohn's disease. Methods: To assess the efficacy and safety of slow- release mesalamine (Pentasa) in maintaining remission in Crohn's disea se, 161 patients with inactive disease were randomized to receive eith er Pentasa (2 g/day) or placebo in a 2-year double-blind, multicenter trial. Two strata were defined according to the duration of their remi ssion: < 3 months (n = 64) or 3-24 months (n = 97), presumed to be hig h and 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 benef it from Pentasa in the high relapse risk stratum. In this stratum, the 2-year on-going remission rate was of 29 % +/- 9 % and 45 % +/- 11 % (mean +/- SD) in the placebo and Pentasa groups, respectively. The inc idences of side effects were similar in both groups. Conclusion: Penta sa (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 .