The US Food and Drug Administration (FDA) has approved Janssen Biotech's Remicade (infliximab) for the treatment of moderately to severely active ulcerative colitis in paediatric patients who have had an inadequate response to conventional therapy.
The approval is backed by adequate and well-controlled studies of Remicade in adults with ulcerative colitis, plus additional data from a pivotal Phase III study.
The randomised, multicentre, open-label trial was designed to evaluate the efficacy of a three-dose Remicade regimen in inducing clinical response in paediatric patients with moderately to severely active ulcerative colitis and to assess the safety of Remicade during induction and maintenance treatment.
The primary endpoint, clinical response at week eight, was defined as a decrease from baseline in the Mayo score of at least 30% and at least three points, with a decrease in rectal bleeding subscore of at least 1 or a rectal bleeding subscore of 0/1.
The study included 60 patients, aged six to 17, with a median disease duration of 1.4 years. It demonstrated that treatment with 5mg/kg of Remicade induced a clinical response in 73% of patients at week eight, and showed a safety profile consistent with previous clinical trials conducted in an adult population.