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Long-Term Efficacy and Safety of Multi-Matrix Mesalazine Maintenance Therapy in Pediatric Patients with Ulcerative

Toshiaki Shimizu1, Daisuke Tokuhara2,3, Shigeo Nishimata4

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

Pediatric Gastroenterology, Hepatology & Nutrition
|January 22, 2026
PubMed

Insights

Multi-matrix mesalazine effectively maintained remission in pediatric ulcerative colitis (UC) patients in Japan over 48 weeks. The treatment showed a favorable safety profile, with no severe adverse events reported.

Area of Science:

  • Gastroenterology
  • Pediatric Gastroenterology
  • Pharmacology

Background:

  • Ulcerative colitis (UC) is a chronic inflammatory bowel disease affecting children and adults.
  • Maintaining remission is crucial for long-term patient outcomes.
  • Pediatric UC management requires specific efficacy and safety data.

Purpose of the Study:

  • To evaluate the long-term efficacy and safety of multi-matrix mesalazine in pediatric patients with UC in remission.
  • To assess the nonoccurrence of rectal bleeding as a primary efficacy endpoint.

Main Methods:

  • A 48-week, multicenter, open-label, uncontrolled study in Japan.
  • 23 pediatric patients (<17 years) with UC in remission received oral multi-matrix mesalazine (40 mg/kg/day).
  • Primary endpoint: nonoccurrence of rectal bleeding assessed by the Ulcerative Colitis Disease Activity Index (UC-DAI).

Main Results:

  • 73.9% of patients achieved the primary endpoint (no rectal bleeding), exceeding the 50% threshold.
  • Adverse events (AEs) occurred in 87.0% of patients; 13.0% were study drug-related.
  • No deaths or severe/serious study drug-related AEs were reported.

Conclusions:

  • Multi-matrix mesalazine demonstrated long-term efficacy in maintaining remission for pediatric UC patients in Japan.
  • The safety profile was consistent with known mesalazine-associated risks.
  • The study supports the use of multi-matrix mesalazine for long-term pediatric UC remission maintenance.
Abstract

Keywords:
ChildClinical trialMaintenanceMesalamineOnce-dailyUlcerative colitis

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