Tumour necrosis factor plays a pivotal role in Crohn's disease intestinal inflammation. Blocking this cytokine by means of the chimeric monoclonal antibody infliximab has led to a rapid reduction in mucosal inflammation. More than 65% of refractory Crohn's disease patients treated with infliximab showed a remarkable improvement in their symptoms, which was maintained by repeated infusions every 2 months up to 44 weeks. Patients with draining enterocutaneous fistulae also benefited from infliximab treatment, with more than 60% of fistulae healed after 3 infusions. Adverse events following infliximab infusions were mild and transient, occurring with the same frequency in infliximab and placebo-treated patients. In conclusion, infliximab appears to offer a promising novel therapeutic agent for refractory and fistulizing Crohn's disease. Long-term risks and benefits remain to be determined.