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Balancing the risks and benefits of prolonged use of infliximab
  1. Jürgen Schölmerich
  1. Dr Profesor Jürgen Schölmerich, Department of Internal Medicine I, University Regensburg, D-93042 Regensburg, Germany; juergen.schoelmerich{at}

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In this issue of Gut, two papers describe the vast experience of the group in Leuven, Belgium, with the use of infliximab in Crohn’s disease. The first report (see page 492) describes 614 patients, mostly with luminal disease and about 25% with fistulising disease treated over a period of 12 years. A sustained benefit was seen in 63%; in a third even after stopping the drug while in remission.1 Twenty percent of patients withdrew from treatment due to loss of response and 11% had no initial response. Of those patients with an initially elevated C-reactive protein (CRP), 77% showed a “biological response”, which had a positive predictive value for a better clinical outcome. Out of 10 deaths, one was directly related to therapy, three were possibly rèlated and six were not related.

The second report (see page 501) assessed medical records of 734 patients with inflammatory bowel disease (IBD), the majority with Crohn’s disease, treated with infliximab during 14 years, and compared them with 666 patients who did not receive infliximab followed during this period.2 Median follow-up was more than twice as long for controls than for infliximab patients (58 months; 33–88 months). A total of 113 severe adverse events occurred in 93 treated patients, and 157 in 126 control patients. Mortality, malignancies and infection rates did not differ between the two populations. However, the control group was older and received steroids much more often during the much longer follow-up.

To me there is an important message from these data to all patients with Crohn’s disease …

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