"New drugs: kids come first": children should be included in trials of new biological treatments.

The advent of biological therapies has dramatically revolutionized the treatment options for refractory inflammatory bowel disease (IBD). Of all the biologics evaluated to date, infliximab, an anti-tumor necrosis factor-alpha monoclonal chimeric antibody, has been shown to be an extremely potent drug for acute and maintenance treatment of both adult and pediatric patients with severe IBD, especially in those with Crohn's disease, whereas other biological agents are undergoing evaluation in several clinical trials. Although infliximab has preferentially been used as rescue therapy for IBD patients refractory to traditional drugs, clinical and immunological arguments seem to indicate that the biological agents are an advantageous treatment for children with IBD when given early in the course of the disease. This, however, requires multicenter randomized controlled trials to prove.