What are the risks of biologic therapy in rheumatoid arthritis? An update on safety.

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J Rheumatol 2002 Sep;29 Suppl 65:33-8

What are the risks of biologic therapy in rheumatoid arthritis? An update on

safety.

Weisman MH.

Division of Rheumatology, Cedars-Sinai Medical Center, Los Angeles,

California 90048, USA. weisman@...

The tumor necrosis factor-alpha (TNF-alpha) blockers infliximab and

etanercept and the recombinant interleukin 1 (IL-1) receptor antagonist

anakinra are effective in patients with active rheumatoid arthritis (RA).

Here, information in the medical literature and public domain is used to

consider the safety of these biologic agents. TNF-a inhibition with

infliximab has been associated with reactivation of tuberculosis and

possibly development of other opportunistic infections (histoplasmosis,

listeriosis, and pneumocystis). Exacerbations of multiple sclerosis and

other central nervous system events have been reported with etanercept and

infliximab. Recently, a review of preliminary data from an ongoing phase II

study suggests that infliximab may worsen congestive heart failure. On the

basis of clinical trials, there appears to be a higher incidence of serious

infections seen in anakinra patients compared with controls; the particular

combination of anakinra and etanercept may be associated with a higher

incidence of serious infections and clinically significant leukopenia.

Additional data are needed to understand whether all these safety issues are

unique to an individual biologic agent or representative of a class effect.

At this time, treating physicians must carefully weigh the benefits of these

new biologics against their risks, particularly in patients at risk of

infection.

PMID: 12233841 [PubMed - in process]