Efficacy and safety of mesalamine suppositories for treatment of ulcerative proctitis in children and adolescents

Background: Treatment of ulcerative proctitis has not been well studied in pediatric populations. We conducted an open‐label trial to evaluate the clinical efficacy of a mesalamine suppository (500 mg) to treat pediatric patients with mild to moderate ulcerative proctitis. Methods: Pediatric patients (5–17 years of age) with ulcerative proctitis were enrolled for baseline evaluations, including a flexible sigmoidoscopic (or colonoscopic) assessment with biopsies performed at study entry. Eligible patients were started on mesalamine suppositories (500 mg) at bedtime. Two follow‐up visits were scheduled after 3 and 6 weeks of treatment. The dose could be increased to 500 mg twice daily at the week 3 follow‐up visit if deemed appropriate by the investigator based on the Disease Activity Index (DAI) assessment. The primary outcome measure was a DAI derived from a composite score of stool frequency, urgency of defecation, rectal bleeding, and general well‐being. Results: Forty‐nine patients were included in the intent‐to‐treat analysis. The mean DAI value decreased from 5.5 at baseline to 1.6 and 1.5 at weeks 3 and 6, respectively ( P < 0.0001). Only 4 patients had their dose increased to 500 mg twice daily at week 3. Forty‐one patients experienced at least one adverse event, most of which were deemed mild and unrelated to study therapy. The most common treatment‐emergent adverse events were gastrointestinal ( n = 30, 61.2%). Conclusions: This study showed that a daily bedtime dose of a 500 mg mesalamine suppository is safe and efficacious in children with ulcerative proctitis. Inflamm Bowel Dis 2010