Biologic therapies in RA and drug-induced lupus

April 30, 2004

Bulletin of the Rheumatic Diseases

Volume 52, Number 8

Safety of New Biologic Therapies in Rheumatoid Arthritis

...

Drug-induced Lupus. ANA positivity is commonly found in 30% to 40% of RA

patients, regardless of DMARD use. In controlled clinical trials, the

incidence of new ANA positivity ranged from 26% to 49% with infliximab

to 11% with etanercept and 12.9% with adalimumab-treated patients

(3,4,5,6). However, ANA positivity has no pathogenic significance in

these patients. Possibly of greater concern is the occurrence of native

(or double-stranded) DNA antibodies found in a subset of infliximab (8%

to 15%), etanercept (3% to 15%), and adalimumab (5.6%) treated patients.

Nevertheless, the incidence of TNF inhibitor-related drug-induced lupus

is very rare. Among 1,897 infliximab-treated patients, there are only 4

reports of a lupus-like disease (0.2%) (26).

Several reports of lupus-like disease have appeared in the postmarketing

era (26,27,28,29,30). Most patients appear to have mild to moderate

symptoms that include fever, arthritis, serositis, rashes (ie, facial,

discoid, or subacute cutaneous lupus or vasculitic rashes), and

autoantibodies. While most have shown positive serologies for

antinuclear antibodies and anti-dsDNA antibodies, other antibodies

against Sm, RNP, histone, and cardiolipin and hypocomplementemia have

been observed less frequently. There have been no clinical reports of

the nephritis, cerebritis, or antiphospholipid syndrome. All cases

resolved when the TNF inhibitor was withdrawn. Routine monitoring for

ANA or DNA autoantibodies in patients receiving anti-TNF therapy is not

advised but may be indicated in patients who exhibit either an

unexpected flare of their arthritis, fever, serositis, or rash.

...

I'll tell you where to go!

Mayo Clinic in Rochester

s Hopkins Medicine

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