RESEARCH - Safety of Enbrel in patients at high risk for mycobacterial TB infections

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J Rheumatol. 2009 May;36(5):914-7. Epub 2009 Mar 30.

Safety of etanercept in patients at high risk for mycobacterial

tuberculosis infections.

Aggarwal R, Manadan AM, Poliyedath A, Sequeira W, Block JA.

Department of Rheumatology, Rush University Medical Center, Chicago,

IL 60612, USA.

OBJECTIVE: The magnitude of the risk of reactivation of tuberculosis

(TB) on use of etanercept, especially in patients with positive

purified protein derivative (PPD) test, has not been assessed. We

evaluated the risk of developing active TB among PPD-positive patients

treated with etanercept. METHODS: All patients with a positive PPD

test, as defined by American Thoracic Society guidelines, who received

etanercept at Cook County Hospital from 2001 to 2008 were

retrospectively reviewed. The primary endpoint was the development of

active TB either while receiving or after completing etanercept

therapy.

RESULTS: Four hundred eighty-seven patients received etanercept, of

whom 84 were PPD-positive and constituted the primary cohort. The

cohort was composed largely of patients who were at high risk for

development of active TB: born in endemic area (80%), ethnic/racial

minorities (51 Hispanic, 16 African American, and 8 Asian), and low

socioeconomic status (66, 78.57%). Overall etanercept exposure was a

mean of 24.6 months (range 3 to 60 mo), with 196 patient-years of

etanercept exposure in PPD-positive individuals. Indications for

etanercept use included rheumatoid arthritis 58 (69%), ankylosing

spondylitis 11 (13%), psoriatic arthritis 13 (15.5%), juvenile

inflammatory arthritis 1 (1.2%), and vasculitis 1 (1.2%). Of the 80

subjects, 74 received treatment for latent TB infection (LTBI) prior

to initiating etanercept. A comprehensive review of these patients'

medical records failed to reveal any active TB infection.

CONCLUSION: This systematic analysis suggests that the risk of

reactivation of LTBI during etanercept therapy is low in appropriately

treated individuals.

PMID: 19332623

http://www.ncbi.nlm.nih.gov/pubmed/19332623

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