title: 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].
  
  
  CONCLUSIONS
  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.affiliation: Paediatric and Gastroenterology and Nutrition Unit, Tel Aviv University, Tel Aviv, Israel.
authors.forename: Arie
authors.initials: A
authors.lastname: Levine
authors.affiliation: Soroka University Medical Center and Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.
authors.forename: Baruch
authors.initials: B
authors.lastname: Yerushalmi
authors.affiliation: Kaplan Hospital, Rehovot, Israel.
authors.forename: Michal
authors.initials: M
authors.lastname: Kori
authors.affiliation: Assaf Harofeh Medical Center, Tel Aviv, Israel.
authors.forename: Efrat
authors.initials: E
authors.lastname: Broide
authors.affiliation: Schneider's Children Hospital, Petach Tikva, Israel.
authors.forename: Yael
authors.initials: Y
authors.lastname: Mozer-Glassberg
authors.affiliation: Rambam Medical Center, Haifa, Israel.
authors.forename: Ron
authors.initials: R
authors.lastname: Shaoul
authors.affiliation: Children's Hospital and Helsinki University, Helsinki, Finland.
authors.forename: Kaija-Leena
authors.initials: KL
authors.lastname: Kolho
authors.affiliation: Hadassah Medical Center, Jerusalem, Israel.
authors.forename: Eyal
authors.initials: E
authors.lastname: Shteyer
authors.affiliation: French Hospital, Nazareth Hospital, Israel.
authors.forename: Hussein
authors.initials: H
authors.lastname: Shamaly
authors.affiliation: Juliet Keidan Institute of Paediatric Gastroenterology, Hebrew University of Jerusalem, Jerusalem, Israel.
authors.forename: Oren
authors.initials: O
authors.lastname: Ledder
authors.affiliation: Tel Aviv Medical Center, Tel Aviv University, Israel.
authors.forename: Shlomi
authors.initials: S
authors.lastname: Cohen
authors.affiliation: Haemek Hospital, Afula, Israel.
authors.forename: Sarit
authors.initials: S
authors.lastname: Peleg
authors.affiliation: Paediatric and Gastroenterology and Nutrition Unit, Tel Aviv University, Tel Aviv, Israel.
authors.forename: Chen Sarbagili
authors.initials: CS
authors.lastname: Shabat
authors.affiliation: Juliet Keidan Institute of Paediatric Gastroenterology, Hebrew University of Jerusalem, Jerusalem, Israel.
authors.forename: Gili
authors.initials: G
authors.lastname: Focht
authors.affiliation: Juliet Keidan Institute of Paediatric Gastroenterology, Hebrew University of Jerusalem, Jerusalem, Israel.
authors.forename: Ebby
authors.initials: E
authors.lastname: Shachmon
authors.affiliation: Epidemiology and Research Unit, Ariel University, Ariel, Israel.
authors.forename: Mona
authors.initials: M
authors.lastname: Boaz
authors.affiliation: Poriah Hospital, Tiberius, Israel, and Faculty of Medicine in Galilee, Bar-Ilan University, Sefad, Israel.
authors.forename: Avi
authors.initials: A
authors.lastname: On
authors.affiliation: Juliet Keidan Institute of Paediatric Gastroenterology, Hebrew University of Jerusalem, Jerusalem, Israel.
authors.forename: Dan
authors.initials: D
authors.lastname: Turner
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D004733:Enema; D005260:Female; D006801:Humans; D008297:Male; D019804:Mesalamine / Q000008:administration & dosage* / Q000627:therapeutic use; D011446:Prospective Studies; D012074:Remission Induction / Q000379:methods; D016037:Single-Blind Method; D017211:Treatment Failure
chemical_list: D019804:Mesalamine
keywords: Drugs; child; ulcerative colitis