Safety of infliximab in Crohn's disease: A large single-center experience

✍ Scribed by H. Hamzaoglu; J. Cooper; M. Alsahli; K.R. Falchuk; M.A. Peppercorn; R.J. Farrell

• Publisher: John Wiley and Sons
• Year: 2010
• Tongue: English
• Weight: 135 KB
• Volume: 16
• Category: Article
• ISSN: 1078-0998
• DOI: 10.1002/ibd.21290

✦ Synopsis

Background:

The aim of this study was to evaluate the shortand 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.