Use of anti-tumour necrosis factor agents in inflammatory bowel disease - European guidelines for 2001-2003

The introduction of novel anti-tumor necrosis factor (TNF) agents has not o nly led to impressive new therapeutic opportunities but also resulted in un certainty regarding their optimal use and possible side effects. Guidelines are presented here for the use of anti-TNF agents in gastrointestinal diso rders. Experts were chosen from different European countries by an algorith m to avoid bias. An expert consensus on guidelines was established using a two-stage procedure of systematic Medline and abstract search for evidence and a qualifying meeting to derive recommendations. Detailed guidelines wer e developed for the use and the future clinical development of anti-TNF age nts in inflammatory bowel disease. Grading of available evidence and gradin g of recommendations were performed according to AHCPR guidelines. At prese nt infliximab is the only registered agent for Crohn's disease. Infliximab should be always used at a dose of 5 mg/kg. The guidelines define the indic ations both in refractory and in fistulating disease for the readministrati on and before surgery. Guidelines for safety and for concomitant treatments are given. Prospects, potential clinical use, and future directions for th e clinical development of other anti-TNF agents are detailed. Clinical use of anti-TNF agents will be influenced by a large number of clinical trials being concluded in 2001 and 2002. It is likely that anti-TNF therapies will become an important long-term therapy for a proportion of patients with Cr ohn's disease. Biological agents will be followed by smaller and more stabl e, orally available compounds. These guidelines will be succeeded by a form al public consensus in 2002/2003.