A randomized, placebo-controlled, double-blind trial of mesalamine in the maintenance of remission of Crohn's disease

Background & Aims: The efficacy of mesalamine for the maintenance of remission in patients with Crohn's disease is controversial, The aim of this study was to conduct a double-blind, placebo-controlled study of mesalamine (750 mg four times a day for 48 weeks) in maintaining remission in 293 patients with Crohn's disease, Patients were stratified according to the method of induction of remission (medical or surgical), Methods: Patients were assessed at weeks 4, 12, 24, 36, and 48, Relapse was defined as a Crohn's Disease Activity Index of >150 (+60 points over baseline), Results: Of the 293 patients, 246 (84%) returned for at least 4 weeks of follow-up and were included in the final analysis, Thirty of the 118 (25%) who received mesalamine had a relapse compared with 47 of 128 (36%) receiving placebo (P = 0.056), Among those with relapse, the time to relapse was 119 days for the mesalamine-treated patients compared with 109 days for placebo-treated patients (P = NS), However, 25% of mesalamine-treated patients had relapsed by 249 days of follow-up compared with 154 days for placebo-treated patients, Subgroup analysis showed that patients with ileocecal-colonic disease or patients who were women had fewer relapses on mesalamine therapy than placebo-treated patients (21% vs, 41%, P = 0.018; and 19% vs, 41%, P = 0.003, respectively), Conclusions: Mesalamine treatment reduced relapse compared with placebo treatment, although conventional statistical significance was not achieved.