Background:: The aim of this study was to evaluate the short‐ and long‐term safety experience of infliximab treatment in patients with Crohn's disease (CD) in clinical practice.
Methods:: The medical records of 297 consecutive patients with CD treated with infliximab at the Beth Israel Deaconess Medical Center were reviewed for demographic features and adverse events.
Results:: The 297 patients received a total of 1794 infusions. Patients received a median of four infusions and had a median follow‐up of 14.3 months. Forty‐four patients (15%) experienced a serious adverse event, requiring the infusion to be stopped in 33 patients (11%). Acute infusion reactions occurred in 18 patients (6%) including respiratory problems in 10 patients (3%) and an anaphylactoid reaction in 1 patient (0.3%). Serum sickness‐like disease occurred in one patient (0.3%) and three patients (1%) developed drug‐induced lupus. One patient developed a probable new demyelination disorder. Eight patients (2.7%), all of whom were on concurrent immunosuppressants, developed a serious infection, one resulting in fatal sepsis. Six patients (2%) developed malignancies including two lymphomas and two skin cancers. A total of four (1.3%) deaths were observed (median age 72.5 years); two due to gastrointestinal bleeding, one due to sepsis, and one due to malignancy.
Conclusions:: While short‐ and long‐term infliximab therapy was generally well tolerated, serious adverse events occurred in 15% of patients including drug‐induced lupus, fatal sepsis, and malignancy. Concomitant immunosuppressants were significantly associated with infections and deaths, particularly among elderly patients. (Inflamm Bowel Dis 2010)