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

Ulcerative proctitis constitutes a large portion of newly diagnosed ulcerative colitis cases.1–4 It is defined as disease limited to the distal colon (the rectum), not extending beyond 15–20 cm proximal to the anal verge. The first line treatment for ulcerative proctitis is 5-aminosalicylic acid (5-ASA/mesalamine), administered as an oral medication or as rectal suppositories (1 g/day), enemas, foams, or gels (1–4 g/day).5–7 The therapeutic effect of mesalamine is attributed to its local concentration on the intestinal mucosa and not to its serum levels, which are very low due to a rapid metabolism of mesalamine into its main acetylated metabolites excreted in urine.8 Studies have shown that higher concentrations of the drug in inflamed colonic mucosa enhance response to treatment.9,10 Current treatment options aim at inducing and maintaining remission of disease-related symptoms and decrease the risk of drug-related adverse events.11 Mesalamine 500 mg suppositories have been used worldwide for more than 20 years with proven safety and efficacy in the adult population.5,12–16 Most adult patients respond to a twice daily dosing, in the morning and at bedtime. However, about 20% of ulcerative colitis patients have disease onset before 20 years of age.17–19 Pediatric patients will thus require long-term maintenance therapy with 5-aminosalicylate (5-ASA).20 Even though the presenting symptoms and therapeutic management options are similar in adults and children, data on the efficacy and safety of short- and long-term mesalamine treatment in pediatric patient populations are lacking.21 Clearly, clinical trials are needed for pediatric patients with inflammatory bowel disease (IBD) in general and ulcerative proctitis in particular. This is especially true considering the recently documented increase in the incidence rate of IBD among pediatric patients (from 9.5 per 100,000 in 1994 to 11.4 per 100,000 in 2005).19 In the present study we evaluated the clinical efficacy and safety of mesalamine 500 mg suppositories in a population of pediatric patients with ulcerative proctitis.