REVIEW - Long-term risks associated with biologic response modifiers used in rheumatic diseases

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Curr Opin Rheumatol. 2004 May;16(3):199-205.

Long-term risks associated with biologic response modifiers used in

rheumatic diseases.

Imperato AK, Smiles S, Abramson SB.

New York University School of Medicine/Hospital for Joint Diseases, 301

East 17th Street, Room 1410, New York, NY 10003, USA.

impera01@...

PURPOSE OF REVIEW: The introduction of tumor necrosis factor-alpha

antagonists in 1998 has had a significant impact on the treatment of

rheumatoid arthritis. However, as use of these agents has increased

worldwide, infrequent adverse events that were not apparent in pivotal

controlled clinical trials required for registration have emerged.

RECENT FINDINGS: These adverse events include serious infections,

particularly tuberculosis, which may be atypical in presentation.

Concern regarding increased risk of lymphoma has also emerged, although

it remains unclear whether the risk exceeds that observed in other

rheumatoid arthritis patients with comparable disease activity.

Development of a systemic lupus erythematosus-like syndrome, which

typically abates after discontinuation of the drug, is another rare

complication that was further reported during the past year. Finally,

additional cases of congestive heart failure and demyelinating syndromes

(including cases resembling progressive multifocal leukoencephalopathy)

have been reported that appear to be related to the tumor necrosis

factor-alpha antagonists.

SUMMARY: Additional postmarketing surveillance of these and other

serious adverse events is necessary to determine the true risk of their

occurrence, and whether a reassessment of the overall risk-benefit of

tumor necrosis factor-alpha antagonists will be required.

PMID: 15103245

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve & db=pubmed & dopt=Abstra\

ct & list_uids=15103245 & itool=iconabstr

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