Multimatrix Mesalamine effective in treatment of paediatric Ulcerative Colitis

Ulcerative colitis (UC) is a common inflammatory bowel disease in children. The large intestine and rectum gets inflamed causing diarrhea or frequent emptying of the colon. Mesalamine, also known as 5-aminosalicylic acid (5-ASA), is a medication used to treat ulcerative colitis. Its safety is well known in adults whereas very little is known about its safety in children.

The current study evaluated the safety and efficacy of low-dose and high-dose once-daily multimatrix mesalamine in children and adolescents with mild-to-moderate UC or those in remission and reported that administration of once-daily multimatrix mesalamine in paediatric patients was beneficial when compared with that reported in adults with mild-to-moderate UC. The findings of the study are published in The Lancet.

The study was a prospective, randomised, parallel-group, phase 3 study (8-week double-blind acute [DBA] phase; 26-week double-blind maintenance [DBM] phase; and an additional 8-week, open-label acute [OLA] phase) was conducted in 33 sites across North America, Europe, and the Middle East between December 12, 2014, and November 28, 2018. Eligible patients aged 5–17 years and weighing 18–90 kg were randomised 1:1 to either low (900–2400 mg) or high (1800–4800 mg) oral doses of multimatrix mesalamine once daily, stratified by body weight. Interactive response technology was used for randomisation. The primary efficacy outcome was to estimate the clinical response of multimatrix mesalamine (two doses) in different weight groups.