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SPECIAL ARTICLE: Review of Literature: General Infectious Diseases

TUBERCULOSIS ASSOCIATED WITH IMFLIXIMAB, A TUMOR NECROSIS FACTOR ALPHA-NEUTRALIZING AGENT

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Infectious Diseases in Clinical Practice: December 2001 - Volume 10 - Issue 9 - p 498
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TUBERCULOSIS ASSOCIATED WITH IMFLIXIMAB, A TUMOR NECROSIS FACTOR ALPHA-NEUTRALIZING AGENT

[Keane J et al. NEJM 2001;345:1098]:

The authors from Boston University School of Medicine and the FDA report 70 cases of tuberculosis associated with imfliximab using the FDA’s Adverse Event Reporting System for 1998–May 2001. Treatment had continued for a median of 12 weeks, and 40 of the 70 cases were extrapulmonary. The authors warn that use of this drug should be preceded by screening for latent tuberculosis or active disease.

Comment.

Infliximab (Remicade) is monoclonal antibody versus TNF-a, which is used for rheumatoid arthritis and Crohn’s disease. The drug was approved by the FDA in 1998 with the recommendation for treatment by infusions. This report claims that about 45,000 patients in the US have received it for rheumatoid arthritis and 76,000 have received it for Crohn’s disease. The role of TNF in tuberculosis immune response is not clear, but it appears to be an important component in animal models (Immunology 2001;102:248). The authors seem justified in their conclusion that the 70 cases reported to AERS, the passive Med Watch program of the FDA, is much higher than would be anticipated. Further, the pattern of tuberculosis was unusual in that 56% had extrapulmonary TB compared to 18% who are reported with extrapulmonary disease in the U.S. Also noteworthy was the observation that foreign-born persons were not over-represented. The recommendation is for evaluation of patients for latent or active TB prior to treatment and the use of prophylaxis prior to use of Remicade for those with a positive PPD. What is unclear in this group is the threshold for a positive PPD.

© 2001 Lippincott Williams & Wilkins, Inc.