Prevention of relapse by mesalazine (Pentasa) in pediatric Crohn's disease: a multicenter, double-blind, randomized, placebo-controlled trial.

Summary Aim This study aimed to test the efficacy of mesalazine in maintaining remission in pediatric Crohn's disease (CD) following successful flare-up treatment. Methods In this double-blind, randomized, placebo-controlled trial, 122 patients received either mesalazine 50 mg/kg per day ( n  = 60) or placebo ( n  = 62) for one year. Treatment allocation was stratified according to flare-up treatment (nutrition or medication alone). Recruitment was carried out over two periods, as the first period's results showed a trend favoring mesalazine. Relapse was defined as a Harvey–Bradshaw score more than or equal to 5. Time to relapse was analyzed using the Cox model. Results The one-year relapse rate was 57% ( n  = 29) and 63% ( n  = 35) in the mesalazine and placebo groups, respectively. We demonstrated a twofold lower relapse risk ( P Conclusion Overall, mesalazine does not appear to be an effective maintenance treatment in pediatric CD.