COMMENTARY

Infliximab

Balancing the risks and benefits of infliximab in the treatment of inflammatory bowel disease

W J Sandborn and E V Loftus

Inflammatory Bowel Disease Clinic, Division of Gastroenterology and Hepatology, Mayo Clinic and Mayo Foundation, Rochester, Minnesota, USA

Correspondence to:
Correspondence to:
Dr W J Sandborn
Mayo Clinic, 200 First Street SW, Rochester, MN 55905, USA; sandborn.william@mayo.edu

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Patients with moderate to severely active Crohn’s disease treated with infliximab may have a small but real risk of developing severe infections, opportunistic infections, and non-Hodgkin’s lymphoma

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Keywords: Crohn’s disease; inflammatory bowel disease; infliximab; lymphoma; mortality; ulcerative colitis

The first 150 words of the full text of this article appear below.

Infliximab, a monoclonal antibody to tumour necrosis factor (TNF) , is an important advance in the treatment of Crohn’s disease.^1–5 The efficacy of infliximab for the treatment of ulcerative colitis is still unclear.^6,7 Infliximab was approved for the treatment of Crohn’s disease in 1998 based on a 12 week phase 2 trial in 108 patients¹ (followed by a 36 week extension trial)³ and a small phase 3 trial in 94 patients,² both of which showed compelling efficacy. Because of the possibility of open label crossover at week 4, 102 of 108 patients in the phase 2 trial received infliximab by week 12. Thus only six patients in the phase 2 study and 31 patients in the phase 3 study who received placebo were available for safety follow up without crossover to infliximab. Although not all patients enrolled in these studies were receiving concomitant corticosteroids and/or azathioprine or 6-mercaptopurine, regulatory . . . [Full text of this article]

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