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