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Efficacy and Safety of High-Dose Multimatrix Mesalazine in Pediatric Patients with Mild-to-Moderate Active Ulcerative

Toshiaki Shimizu1, Itaru Iwama2, Toshihiko Kakiuchi3

  • 1Department of Pediatrics, Juntendo University Faculty of Medicine, Tokyo, Japan.

Pediatric Gastroenterology, Hepatology & Nutrition
|May 18, 2026
PubMed

Insights

High-dose multimatrix mesalazine showed clinically meaningful efficacy in treating pediatric ulcerative colitis (UC) in Japan. The treatment was generally safe, with no significant new safety concerns identified beyond known risks of mesalazine.

Area of Science:

  • Pediatric Gastroenterology
  • Clinical Pharmacology
  • Inflammatory Bowel Disease Research

Background:

  • Ulcerative colitis (UC) is a chronic inflammatory bowel disease affecting children and adolescents.
  • Effective and safe treatment options for pediatric UC are crucial for long-term management.
  • Mesalazine is a common treatment, but high-dose efficacy in pediatric populations requires further investigation.

Purpose of the Study:

  • To evaluate the efficacy and safety of high-dose multimatrix mesalazine in pediatric patients with active ulcerative colitis.
  • To determine the clinical remission rate in children and adolescents treated with this regimen.
  • To assess the incidence and nature of adverse events associated with high-dose multimatrix mesalazine.

Main Methods:

  • An open-label, uncontrolled, multicenter trial conducted in Japan.
  • Inclusion of 27 pediatric patients (<17 years) with mild-to-moderate active UC.
  • Treatment with multimatrix mesalazine at 80 mg/kg orally once daily for 8 weeks, with clinical remission assessed by UC-DAI score.

Main Results:

  • A clinical remission rate of 25.9% (95% CI: 11.1%, 46.3%) was observed at the end of treatment.
  • The lower limit of the confidence interval exceeded the predefined efficacy threshold of 10%.
  • Adverse events occurred in 66.7% of patients, with 18.5% experiencing drug-related adverse events; drug intolerance was the main severe event.

Conclusions:

  • High-dose multimatrix mesalazine demonstrated clinically meaningful efficacy in treating mild-to-moderate active pediatric UC in Japan.
  • The safety profile was consistent with known risks of mesalazine, with no unexpected safety concerns.
  • This regimen represents a potentially valuable treatment option for pediatric UC patients.
Abstract

Keywords:
ChildClinical trialMesalamineOnce-dailyUlcerative colitis

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