Mesalamine Enemas for Induction of Remission in Oral Mesalamine-refractory Pediatric Ulcerative Colitis: A Prospective Cohort Study.

Abstract

BACKGROUND:

Paediatric ulcerative colitis [UC] is more extensive than adult disease, and more often refractory to mesalamine. However, no prospective trials have evaluated mesalamine enemas for inducing remission in children. Our goal was to evaluate the ability of mesalamine enemas to induce remission in mild to moderate paediatric UC refractory to oral mesalamine.

METHODS:

This was an open-label arm of a previously reported randomised controlled trial of once-daily mesalamine in active paediatric UC [MUPPIT trial]. Children aged 4-18 years, with a Paediatric Ulcerative Colitis Activity Index [PUCAI] score of 10-55, were enrolled after failing at least 3 weeks of full-dose oral mesalamine. Patients treated with steroids or enemas in the previous month and those with isolated proctitis were excluded. Children received Pentasa® enemas 25 mg/kg [up to 1g] daily for 3 weeks with the previous oral dose. The primary endpoint was clinical remission by Week 3.

RESULTS:

A total of 38 children were enrolled (mean age 14.6 ± 2.3 years; 17/38 [45%] with extensive colitis). Clinical remission was obtained in 16 [42%] and response was obtained in 27 [71%] at Week 3. Eight children deteriorated and required steroids. There were no differences in baseline parameters between those who entered or failed to enter remission, including disease extent [43% in left-sided and 41% in extensive colitis] and disease activity [44% in mild and 41% in moderate activity].

CONCLUSION:

Clinical remission can be markedly increased in children who are refractory to oral mesalamaine by adding mesalamine enemas for 3 weeks, before commencing steroids.

• Authors: Arie Levine, Baruch Yerushalmi, Michal Kori, Efrat Broide, Yael Mozer-Glassberg, Ron Shaoul, Kaija-Leena Kolho, Eyal Shteyer, Hussein Shamaly, Oren Ledder, Shlomi Cohen, Sarit Peleg, Chen Sarbagili Shabat, Gili Focht, Ebby Shachmon, Mona Boaz, Avi On, Dan Turner
• Journal: Journal of Crohn's & colitis (J Crohns Colitis) Vol. 11 Issue 8 Pg. 970-974 (Aug 01 2017) ISSN: 1876-4479 [Electronic] England
• PMID: 28369299 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: Copyright © 2017 European Crohn’s and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved. For permissions, please email: [email protected]

Chemical References

• Mesalamine

Topics

• Adolescent
• Child
• Child, Preschool
• Colitis, Ulcerative (drug therapy)
• Enema
• Female
• Humans
• Male
• Mesalamine (administration & dosage, therapeutic use)
• Prospective Studies
• Remission Induction (methods)
• Single-Blind Method
• Treatment Failure