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Ann Intern Med. 2007 Nov 20;147(10):699-702.

Brief communication: characteristics of spontaneous cases of tuberculosis associated with infliximab.

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1
U. S. Food and Drug Administration, Silver Spring, Maryland, USA.

Abstract

BACKGROUND:

A warning for tuberculosis was added to the approved labeling for infliximab in October 2001.

OBJECTIVE:

To describe adverse event reports of tuberculosis during infliximab therapy after labeling changes.

DESIGN:

Case series.

SETTING:

Spontaneous adverse event reports maintained in the Adverse Event Reporting System database in the United States.

PATIENTS:

130 patients with infliximab-associated tuberculosis.

MEASUREMENTS:

Clinical and laboratory data.

RESULTS:

The U.S. Food and Drug Administration received 130 domestic, spontaneous reports of tuberculosis in patients treated with infliximab between 1 November 2001 and 30 May 2006, including 59 (45%) with extrapulmonary disease. The most commonly reported risk factors included concomitant immunosuppressant use (n = 89), history of latent or active tuberculosis (n = 33), and being born into or having spent extensive time in an area where tuberculosis is endemic (n = 25). In the subset of 67 cases with documented initiation of infliximab therapy after the drug labeling change, 34 patients with a negative tuberculin skin test result before initiation of infliximab therapy developed tuberculosis after receiving infliximab.

LIMITATION:

Conclusions from spontaneous case reports may not be generalizable to the entire infliximab-receiving population.

CONCLUSION:

Clinicians should be vigilant in screening and monitoring for tuberculosis in patients receiving infliximab.

[Indexed for MEDLINE]

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