A study from the Johns Hopkins University School of Medicine reported that children and adolescents with ulcerative colitis (UC) reacted to multimatrix mesalamine treatment in ways similar to adults, with the drug showing a good safety and tolerability profile in all age and dose groups examined.
The study, “Randomized clinical trial: pharmacokinetics and safety of multimatrix mesalamine for treatment of pediatric ulcerative colitis,“ was published in the journal Drug Design, Development and Therapy.
Multimatrix mesalamine is an oral formulation of 5-aminosalicylic acid (5-ASA) recommended as first-line therapy for adults with active mild to moderate UC. The drug is often used in children with UC as well, but there is little data supporting its efficacy and safety in this population. There is also no 5-ASA product approved for maintenance of remission in children.
The Phase 1 clinical trial assessed the properties in the body (pharmacokinetics) of both 5-ASA and its main metabolite, acetyl-5-ASA, in 52 children and adolescents at 12 sites across the United States, Poland, and Slovakia. Participants were ages 5–17 and had a diagnosis of UC. They were randomly assigned to receive multimatrix mesalamine 30, 60, or 100 mg/kg once daily for seven days.
The pharmacokinetic data mirrored previous data obtained from adults regarding absorption profiles, the percentage of the 5-ASA absorbed, renal clearance of 5-ASA and Ac-5-ASA, plasma exposure, and the inter-subject variability in pharmacokinetic parameters.
The treatment was also found safe and well-tolerated, with no serious treatment-related adverse events reported. There was also no premature discontinuation of the treatment, and all enrolled participants finished the treatment period.
Mild to moderate treatment-emergent adverse events were reported by 10 participants, and the rates were similar in the different dose groups. The most commonly reported adverse events were abdominal pain, musculoskeletal pain, and headache, each reported in two participants. Two participants experienced adverse events judged to be a result of treatment involving abdominal pain, with vomiting and dehydration in one subject. The types of adverse events were also similar to what has been reported earlier.
The study of multimatrix mesalamine will be continued in further trials, and the results of this study support the proposed doses in a Phase 3 trial investigating the safety and efficacy of multimatrix mesalamine in children with UC.