High‐ and Low‐Dose Oral Delayed‐Release Mesalamine in Children With Mild‐to‐Moderately Active Ulcerative Colitis

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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 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.
Funding Information
  • Janssen Pharmaceutica

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