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Aliment Pharmacol Ther 31, 553–560

Background  Most available data on infliximab therapy come from large, short‐term, pivotal RCTs and concerns about long‐term safety profile still remain.

Aim  To evaluate the long‐term safety profile of infliximab in inflammatory bowel disease (IBD) in a clinical practice setting.

Methods  Since 1999, all IBD patients treated with infliximab were registered and clinical outcomes prospectively recorded up to March 2008, loss of follow‐up or patient’s death. Infliximab regimens and preventive measures were in accordance with the prevalent guidelines or with the manufacturer’s recommendations.

Results  One hundred fifty‐two patients were included (121 Crohn’s disease, 24 ulcerative colitis, 7 indeterminate colitis), with a median of 5 infliximab infusions (IQR 3–8) and 87% of patients received at least three infusions. Seventy‐nine per cent of them received …