The safety profile of infliximab in patients with Crohn's disease: the Mayo clinic experience in 500 patients.

Abstract

BACKGROUND AND 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.

• Authors: Jean-Frederic Colombel, Edward V Loftus Jr, William J Tremaine, Laurence J Egan, W Scott Harmsen, Cathy D Schleck, Alan R Zinsmeister, William J Sandborn
• Journal: Gastroenterology (Gastroenterology) Vol. 126 Issue 1 Pg. 19-31 (Jan 2004) ISSN: 0016-5085 [Print] United States
• PMID: 14699483 (Publication Type: Journal Article)

Chemical References

• Antibodies, Monoclonal
• Gastrointestinal Agents
• Infliximab

Topics

• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Antibodies, Monoclonal (adverse effects)
• Autoimmune Diseases (chemically induced)
• Child
• Child, Preschool
• Crohn Disease (drug therapy, mortality)
• Female
• Gastrointestinal Agents (adverse effects)
• Humans
• Infections (chemically induced, mortality)
• Infliximab
• Likelihood Functions
• Lupus Vulgaris (chemically induced)
• Male
• Middle Aged
• Neoplasms (chemically induced)
• Retrospective Studies
• Serum Sickness (chemically induced)