To assess the risk of serious and nonserious bacterial and viral infections associated
with the use of biologic therapy (abatacept, adalimumab, anakinra, etanercept, infliximab,
and rituximab) in patients with rheumatoid arthritis (RA).
Information was derived from PubMed, EMBASE, and the Cochrane clinical trials register
and database of systematic reviews and relevant congress abstracts up to and including
Compared with the general population, patients with RA have a heightened risk of infection,
including tuberculosis. Long-term clinical trials and postmarketing studies indicate
that anakinra and the tumor necrosis factor (TNF) inhibitors are associated with an
increased risk of infections versus conventional disease-modifying antirheumatic drugs
(DMARDs), especially early in the course of treatment. The most common sites of infection
are the respiratory tract (including pneumonia), skin and soft tissue, and the urinary
tract. The risk of tuberculosis also appears higher with TNF inhibitors (in particular,
infliximab) versus DMARDs, although this can be reduced by screening and prophylaxis.
TNF inhibitors do not appear to significantly increase the risk of reactivating chronic
viral infections. Influenza and pneumococcal vaccinations are generally effective
in the face of TNF inhibitors or abatacept. Available data suggest that the risk of
infections and serious infections with abatacept and rituximab may be similar to that
of the TNF inhibitors. To date, there have been no reports from clinical trials of
increased tuberculosis or opportunistic infections with abatacept or rituximab.
All marketed TNF inhibitors for compared to control RA appear to increase the risk
of serious and nonserious infections compared with DMARDs. Although suggestive, data
for abatacept and rituximab are less definitive and longer periods of patient exposure
to these agents are needed before an assessment of their risks can be made.
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