TB infection in patients with RA and the effect of Remicade therapy

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Arthritis Rheum. 2004 Feb;50(2):372-9.

Tuberculosis infection in patients with rheumatoid arthritis and the

effect of infliximab therapy.

Wolfe F, Michaud K, J, Urbansky K.

National Data Bank for Rheumatic Diseases, Wichita, Kansas, and

University of Kansas School of Medicine, Wichita.

OBJECTIVE: According to the Centers for Disease Control and Prevention,

the 1999 and 2000 incidence rates for tuberculosis (TB) in the US

population were 6.4 and 5.8, respectively, per 100,000 persons.

Recently, reports of TB following infliximab administration have raised

questions regarding the rate of TB in patients with rheumatoid arthritis

(RA) generally and in those treated with infliximab in clinical

practice. We undertook this study to determine the baseline rate of TB

in RA prior to the introduction of infliximab and to determine the rate

of TB among those currently receiving infliximab. METHODS: We surveyed

patients with questionnaires, followed by detailed validation from

medical records and physician reports. In study 1, we evaluated 10,782

RA patients in 1998-1999 prior to the widespread use of infliximab. In

study 2, we evaluated 6,460 infliximab-treated patients in 2000-2002.

RESULTS: In study 1, the lifetime rate of TB was 696 per 100,000

patients (95% confidence interval [95% CI] 547-872). Of these cases,

76.8% occurred prior to the onset of RA. During the period of

prospective followup, 1 case of TB developed during 16,173 patient-years

of followup, yielding a rate of 6.2 cases (95% CI 1.6-34.4) per 100,000

patients. In study 2, the TB incidence rate among infliximab-treated

patients was 52.5 cases (95% CI 14.3-134.4) per 100,000 patient-years of

exposure. Three of the 4 cases occurred in patients with a history of TB

exposure, and no cases occurred in persons with recent TB skin tests or

prophylaxis.

CONCLUSION: The rate of TB is not increased in RA patients generally.

Among infliximab-treated patients, the rate is 52.5 cases (95% CI

14.3-134.4) per 100,000 patient-years of exposure. A thorough medical

history regarding TB, as well as tuberculin testing and radiographic

examination (if indicated), should be an essential component of

anti-tumor necrosis factor therapy.

PMID: 14872478

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