Anti-TNF antibody in Crohn's disease - status of information, comments andrecommendations of an international working group

The chimeric anti-TNF antibody Remicade(R) (Infliximah) has recently been a pproved for human use by the FDA and is now available on the market, Since there is considerable interest in this kind of treatment among patients wit h Crohn's disease, an international working group has summarized the presen tly available information about efficacy side effects and possible problems of this treatment. Studies show that Remicade(R) is effective in the treatment of active Crohn 's disease, maintaining remission and fistulae. The working group does not see Infliximab as a first-line treatment for Clo hn's disease. It may be used in active phase recurrent disease, chronic act ive disease and fistulae if standard treatment was not successful. For the surveillance special attention has to be given to the unknown malignancy ra te of Infliximab. Infusion should, he performed in an institution, routinel y performing intravenous infusions and a two-hour surveillance of the patie nts should be guaranteed to recognize anaphylactic reactions or acute side effects, There is presently no information indication that the combination with immunosuppressants might increase risks or side effects of this treatm ent. Due to the limited information available the working group would prefer to use Remicade(R) in studies only and recommends central collection and docum entation of all data on efficacy and side effects for the next year.