Objective To evaluate the pharmacology, efficacy, safety and role of infliximab in the treatment of paediatric ulcerative colitis.

Data sources A literature search was conducted using Ovid Medline (January 2000–December 2013), Embase (January 1996–December 2013) to identify clinical trials and review articles. Keywords included infliximab, paediatric and ulcerative colitis. References of selected studies were also evaluated for relevant information.

Study selection and data extraction Articles were limited to those published in the English language and studies in humans. Studies included in the review examined paediatric data in ulcerative colitis and Crohn's disease (pharmacokinetics).

Data synthesis Infliximab is approved in the USA and Europe for use in patients with ulcerative colitis, 6 years of age and older. Infliximab has shown efficacy in triggering and maintaining a symptomatic response in retrospective reviews, small cohort studies and a phase 3 clinical trial. Infliximab was determined to be safe, with only a minimal number of adverse drug events identified during studies.

Conclusions Infliximab is currently the only tumour necrosis factor-α inhibitor approved for induction and maintenance of remission of paediatric ulcerative colitis. It provides expansion of available treatment options, may eliminate the need for corticosteroids and can delay colectomy. Despite a triad of black-boxed warnings and a lack of long-term study results, infliximab is generally well tolerated, has proven efficacy for up to 54 weeks and safety for up to 104 weeks. Further comparative studies against conventional therapies are warranted to determine its usefulness as a first-line treatment option.