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

J-P Cezard1, A Munck, O Mouterde

  • 1Service de gastroentérologie pédiatrique, mucoviscidose, nutrition pédiatrique, centre de référence des maladies digestives rares de l'enfant, hôpital Robert-Debré, 75019 Paris cedex 19, France. jean-pierre.cezard@rdb.aphp.fr

Gastroenterologie Clinique Et Biologique
|January 3, 2009
PubMed

Insights

Mesalazine did not effectively maintain remission in pediatric Crohn's disease (CD). This study found no overall benefit of mesalazine for pediatric CD maintenance, suggesting it is not a reliable treatment option.

Area of Science:

  • Pediatric Gastroenterology
  • Inflammatory Bowel Disease Research
  • Clinical Trial Analysis

Background:

  • Pediatric Crohn's disease (CD) requires effective maintenance therapies to prevent relapse.
  • Mesalazine is a common treatment for inflammatory bowel disease, but its efficacy in maintaining remission in pediatric CD is debated.

Purpose of the Study:

  • To evaluate the efficacy of mesalazine in maintaining remission in pediatric patients with Crohn's disease after successful treatment of flare-ups.

Main Methods:

  • A double-blind, randomized, placebo-controlled trial involving 122 pediatric CD patients.
  • Patients received either mesalazine (50mg/kg/day) or placebo for one year, stratified by prior flare-up treatment.
  • Relapse was defined as a Harvey-Bradshaw score ≥5; time to relapse was analyzed using Cox models.

Main Results:

  • The one-year relapse rates were 57% for mesalazine and 63% for placebo.
  • A significant interaction was observed based on recruitment period and prior treatment, with mesalazine showing benefit in one stratum and harm in another.
  • No patient characteristics explained the differing efficacy between recruitment periods.

Conclusions:

  • Mesalazine does not demonstrate overall efficacy as a maintenance treatment for pediatric Crohn's disease.
  • The variable efficacy suggests that mesalazine's role in pediatric CD maintenance requires further investigation, potentially considering different patient subgroups or treatment contexts.
Abstract

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