Oral mesalamine (Pentasa) as maintenance treatment in Crohn's disease: a multicenter placebo-controlled study. The Groupe d'Etudes Thérapeutiques des Affections Inflammatoires Digestives (GETAID)

Gastroenterology. 1993 Feb;104(2):435-9. doi: 10.1016/0016-5085(93)90411-5.


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.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Adult
  • Aminosalicylic Acids / adverse effects
  • Aminosalicylic Acids / therapeutic use*
  • Crohn Disease / drug therapy*
  • Delayed-Action Preparations / adverse effects
  • Delayed-Action Preparations / therapeutic use
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Mesalamine
  • Middle Aged
  • Patient Compliance
  • Treatment Outcome


  • Aminosalicylic Acids
  • Delayed-Action Preparations
  • Mesalamine