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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 concomitant immunomodulators and 70% were pre-medicated with hydrocortisone from the first infusion. After a median follow-up of 142 weeks, 13% presented infusion reactions, 13% viral or bacterial infections and two patients developed neoplasia. The mortality rate was 2.6% (four patients). Conclusions Infliximab therapy is safe when the recommended preventive measures are implemented, with a rate of serious adverse events less than 10%. No new safety signals were found. [ABSTRACT FROM AUTHOR]

Background Infliximab (IFX) could change the course of Crohn’s disease (CD) by reducing steroid use, surgery or prompting earlier introduction of immunomodulators (IMM). Aim To evaluate the impact of IFX availability on the course of early CD. Methods Two cohorts of newly diagnosed CD patients were identified: The first cohort included patients diagnosed from January 1994 to December 1997 and the second from January 2000 to December 2003. All patients were diagnosed, treated and followed up in the same centre until December 1999 (first cohort) or December 2005 (second cohort). Development of disease-related complications, steroid, IMM or IFX requirements and intestinal resections during follow-up were registered. Results A total of 328 patients were included (146 first cohort, 182 second cohort). A similar proportion of patients in both cohorts received steroids, but steroid exposure resulted significantly more intense in the first cohort ( P = 0.001). In the second cohort, 14% of patients received IFX. Thiopurines were used more ( P = 0.001) and earlier ( P = 0.012) in the second cohort. No differences in surgical requirements or the development of disease-related complications were found. Conclusions Following a step-up therapeutic algorithm, IFX availability did not reduce surgical requirements or the development of disease-related complications. Aliment Pharmacol Ther 31, 233–239 [ABSTRACT FROM AUTHOR]