title: High- and low-dose oral delayed-release mesalamine in children with mild-to-moderately active ulcerative colitis.
abstract: OBJECTIVE
  The aim of the study was to assess the safety and efficacy of high- and low-dose oral, delayed-release mesalamine in a randomized, double-blind, active control study of children with mild-to-moderately active ulcerative colitis.
  
  
  METHODS
  Patients ages 5 to 17 years, with a Pediatric Ulcerative Colitis Activity Index (PUCAI) score of ≥ 10 to ≤ 55 and a truncated Mayo Score of ≥ 1 for both rectal bleeding and stool frequency, were enrolled. They received body weight-dependent doses of oral, delayed-release mesalamine for 6 weeks in a low- (27-71 mg · g(-1) · day(-1)) or high-dose group (53-118 mg · g(-1) · day(-1)). The primary endpoint was treatment success, defined as the proportion of patients who achieved remission (PUCAI score <10) or partial response (PUCAI score ≥ 10 with a decrease from baseline by ≥ 20 points). Secondary endpoints included truncated Mayo Score and global assessment of change of disease activity.
  
  
  RESULTS
  The modified intent-to-treat population included 81 of 83 patients enrolled. Treatment success by PUCAI was achieved by 23 of 41 (56%) and 22 of 40 (55%) patients in the mesalamine low- and high-dose groups, respectively (P = 0.924). Truncated Mayo Score (low-dose 30 [73%] and high-dose 28 [70%] patients) and other efficacy results did not differ between the groups. The type and severity of adverse events were consistent with those reported in previous studies of adults with ulcerative colitis and did not differ between groups.
  
  
  CONCLUSIONS
  Both low- and high-dose oral, delayed-release mesalamine doses were equally effective as short-term treatment of mild-to-moderately active ulcerative colitis in children, without a specific benefit or risk to using either dose.
authors.affiliation: *MassGeneral Hospital for Children, Boston, MA †Medpace, Warsaw, Poland ‡Department of Pediatrics, University of California, San Francisco §Methodist Children's Hospital, San Antonio, TX ||Department of Pediatrics, Gastroenterology and Nutrition, Medical University of Wroclaw, Wroclaw ¶Department of Pediatrics, Gastroenterology and Allergology, Medical University of Bialystok, Bialystok #Department of Gastroenterology, Hepatology, and Immunology, Children's Memorial Health Institute, Warsaw, Poland **University Children's Hospital Zagreb, Zagreb, Croatia ††Cook Children's Medical Center, Fort Worth, TX ‡‡Pediatric Gastroenterology, MUSC Pediatric Center for Inflammatory Bowel Disorders, Charleston, SC §§Loma Linda University Children's Hospital, Loma Linda, CA ||||Division of Digestive Diseases, University of Cincinnati, Cincinnati, OH ¶¶US Food and Drug Administration, Silver Spring, MD.
authors.forename: Harland S
authors.initials: HS
authors.lastname: Winter
authors.forename: Piotr
authors.initials: P
authors.lastname: Krzeski
authors.forename: Melvin B
authors.initials: MB
authors.lastname: Heyman
authors.forename: Eduardo
authors.initials: E
authors.lastname: Ibarguen-Secchia
authors.forename: Barbara
authors.initials: B
authors.lastname: Iwanczak
authors.forename: Maciej
authors.initials: M
authors.lastname: Kaczmarski
authors.forename: Jaroslaw
authors.initials: J
authors.lastname: Kierkus
authors.forename: Sanja
authors.initials: S
authors.lastname: Kolaček
authors.forename: Bankole
authors.initials: B
authors.lastname: Osuntokun
authors.forename: J Antonio
authors.initials: JA
authors.lastname: Quiros
authors.forename: Manoj
authors.initials: M
authors.lastname: Shah
authors.forename: Bruce
authors.initials: B
authors.lastname: Yacyshyn
authors.forename: Preston M
authors.initials: PM
authors.lastname: Dunnmon
mesh_terms: D000293:Adolescent; D000894:Anti-Inflammatory Agents, Non-Steroidal; D002648:Child; D002675:Child, Preschool; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D019804:Mesalamine / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D003692:Delayed-Action Preparations; D019804:Mesalamine