Gastroenterology

Gastroenterology

Volume 126, Issue 1, January 2004, Pages 19-31
Gastroenterology

Clinical-alimentary tract
The safety profile of infliximab in patients with Crohn’s disease: The Mayo Clinic experience in 500 patients

https://doi.org/10.1053/j.gastro.2003.10.047Get rights and content

Abstract

Background & Aims: The aim of this study was to evaluate the short- and long-term safety of infliximab in patients with Crohn’s disease in clinical practice. Methods: The medical records of 500 consecutive patients treated with infliximab at the Mayo Clinic were reviewed and abstracted for demographic features and adverse events. The likelihood of a causal relationship to infliximab for each adverse event was determined by calculating an intrinsic likelihood (imputability) score. Results: The 500 patients received a median of 3 infusions and had a median follow-up of 17 months. Forty-three patients (8.6%) experienced a serious adverse event, of which 30 (6%) were related to infliximab. Acute infusion reactions occurred in 19 of 500 patients (3.8%). Serum sickness-like disease occurred in 19 of 500 patients and was attributed to infliximab in 14 (2.8%). Three patients developed drug-induced lupus. One patient developed a new demyelination disorder. Forty-eight patients had an infectious event, of which 41 (8.2%) were attributed to infliximab. Twenty patients had a serious infection: 2 had fatal sepsis, 8 had pneumonia (of which 2 cases were fatal), 6 had viral infections, 2 had abdominal abscesses requiring surgery, one had arm cellulitis, and one had histoplasmosis. Nine patients had a malignant disorder, 3 of which were possibly related to infliximab. A total of 10 deaths were observed. For 5 of these patients (1%), the events leading to death were possibly related to infliximab. Conclusions: Short- and long-term infliximab therapy is generally well tolerated. However, clinicians must be vigilant for the occurrence of infrequent but serious events, including serum sickness-like reaction, opportunistic infection and sepsis, and autoimmune disorders.

Section snippets

Patients and methods

This study is a retrospective cohort study. Eligible patients were patients with CD who were treated with infliximab at the Mayo Clinic in Rochester, Minnesota, between October 1998 and October 2002. All infusions of infliximab were administered to hospital inpatients or in-hospital outpatient infusion centers at 2 Mayo Clinic hospitals. The hospital pharmacy records from these hospitals were used to identify all patients with CD treated with infliximab during the study period. The diagnosis of

Patient characteristics

A total of 512 consecutive patients met the eligibility criteria for the study. Twelve patients refused authorization for review of their medical records for research purposes, leaving a study cohort of 500 patients (98%) who were both eligible and gave written authorization for review of their medical records. A total of 219 male patients and 281 female patients with a median age of 37 years (range, 5–85 years) were included in the study. Twenty-eight of the 500 patients (6%) were children or

Discussion

The safety profile of infliximab is a timely issue because its use and indications are rapidly increasing. Safety data in CD are available from controlled trials of up to 1 year in duration that included 1057 carefully selected patients: 102 of 108 patients with luminal CD received 1–2 induction doses of infliximab over 12 weeks, of whom 37 of 73 were retreated with 1–4 maintenance doses over 36 weeks1, 18; 63 of 94 patients with fistulizing CD received 3 induction doses over 18 weeks2; 573

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    Dr. Loftus was on the Speaker’s Bureau for Centocor.

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