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Background & Aims: Steroid dependence and early relapse are frequent after a prednisolone-induces remission in Crohn's disease. The aim of this trial was to test whether mesalamine started at the onset of steroid tapering increases the rate of weaning from prednisolone and reduces the relapse rate after prednisolone cessation., Methods: One hundred fifty patients with active Crohn's disease were administered oral prednisolone (1 mg.kg(-1). day(-1)) x 3-7 weeks; 129 patients went into clinical remission and were randomized to Pentasa (4 g . day(-1)) or placebo, administered until weaning and for 1 year thereafter., Results: Groups were similar for clinical and biological items collected initially. Weaning failure rate was 30% and 12% in the placebo and mesalamine arms, respectively. At the end of the trial, 9 of 36 patients administered placebo and 14 of 48 administered mesalamine were in remission. Both groups had similar time to relapse curves in the postweaning year; after adjusting for risk factors (high Crohn's Disease Activity Index, white blood cell count of >9 x 10(9) /l-1 at weaning, and use of a medical treatment in the month before inclusion), Pentasa was found to be superior to placebo., Conclusions: After a prednisolone-induces remission in Crohn's disease, mesalamine facilitates steroid withdrawal and, during the postweaning year, may reduce the relapse rate in certain patient subgroups.

The prevention of relapse in quiescent Crohn's disease remains a major therapeutic challenge. The present study is a double blind placebo (P)-controlled, randomized, multicentre cooperative trial designed to test the effectiveness of levamisole (L) in the prophylaxis against flare up in patients with quiescent Crohn's disease. The trial included 2 successive phases: a) phase I:167 patients with inactive disease (but who had not had previous resection of all diseased tissue) were randomly and double blindly assigned to receive either L (150 mg orally once weekly) or P; patients were randomized in 2 strata: those having experienced a recent flare up (within the 3 months preceding their entry into the trial: red strata) versus others (blue strata). Patients were followed up at 3 monthly intervals during 2 years. Initially there was no significant difference between L and P groups as regard to age, sex ratio, duration of disease at the time of randomization, incidence of prior intestinal resection, Crohn's disease topography, clinical activity; biological activity was slightly but significantly higher (P less than 0.05) in the P group. Twelve patients were withdrawn from analysis (lost to follow-up: 2; inadequate respect of the protocol: 10), leaving 155 patients (78 L, 77 P) who completed the study. L did not significantly influence any of the following parameters: incidence of attacks (L: 37 p. 100; P: 35 p. 100), lag time between the entry into the trial and the occurrence of the attack (L: 32.7 +/- 5.2; P: 41.8 +/- 5.8; m +/- SEM; weeks), curves of maintenance in remission (Kaplan-Meier method), outcome rank, severity of attacks. Attempts to analyse separately certain subgroups--subjects with purely colonic (+/- anal) disease, subjects with small bowel localization (+/- anus), patients of the red or blue strata--did not show any statistical difference between L and P. Thirteen patients left the trial for minor intolerance (10 L, 3 P). b) Phase II lasted one further year and involved the patients still in remission and in the trial at the end of phase I (n = 57). Those who had received L during phase I were randomized between continuance of L (L leads to L) vs. a change to P (L leads to P); those who had been on P during phase I were randomized between continuance of P vs. a switch to L.(ABSTRACT TRUNCATED AT 400 WORDS)