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

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

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

Case series.

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

130 patients with infliximab-associated tuberculosis.

Clinical and laboratory data.

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.

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

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