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High- and low-dose oral delayed-release mesalamine in children with mild-to-moderately active ulcerative colitis
Harland S Winter1, Piotr Krzeski, Melvin B Heyman
1*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.
Insights
High- and low-dose oral, delayed-release mesalamine are equally effective for treating pediatric ulcerative colitis. Both doses demonstrated similar safety and efficacy in children with mild-to-moderate disease activity.
Area of Science:
- Pediatric Gastroenterology
- Inflammatory Bowel Disease Research
- Pharmacological Studies in Children
Background:
- Ulcerative colitis (UC) is a chronic inflammatory bowel disease affecting children.
- Optimal dosing of oral mesalamine for pediatric UC requires further investigation.
- Delayed-release mesalamine is a common treatment for mild-to-moderate UC.
Purpose of the Study:
- To evaluate the safety and efficacy of high- versus low-dose oral, delayed-release mesalamine in children with mild-to-moderately active ulcerative colitis.
- To compare treatment success rates, remission, and partial response between different mesalamine dosage groups.
- To assess adverse events associated with varying doses of mesalamine in pediatric patients.
Main Methods:
- A randomized, double-blind, active control study enrolled children aged 5-17 years with mild-to-moderate UC.
- Patients received weight-dependent doses of oral, delayed-release mesalamine (low-dose: 27-71 mg·g⁻¹·day⁻¹; high-dose: 53-118 mg·g⁻¹·day⁻¹) for 6 weeks.
- Treatment success was defined by Pediatric Ulcerative Colitis Activity Index (PUCAI) remission or partial response; secondary endpoints included truncated Mayo Score.
Main Results:
- Treatment success rates were similar between the low-dose (56%) and high-dose (55%) mesalamine groups (P=0.924).
- No significant differences were observed in truncated Mayo Scores or other efficacy measures between the dosage groups.
- Adverse event profiles were consistent with previous adult studies and did not differ between the low- and high-dose groups.
Conclusions:
- Both low- and high-dose oral, delayed-release mesalamine are equally effective for short-term treatment of mild-to-moderate pediatric ulcerative colitis.
- Neither dose demonstrated a specific benefit or increased risk compared to the other in this pediatric population.
- These findings support the use of either dose regimen for managing mild-to-moderate UC in children.
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.
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