Abstract

Autoantibodies often arise before the clinical presentation of autoimmune diseases. In clinical studies of anti-TNF, 52% of (1261) infliximab treated patients who were ANA negative at baseline developed a positive ANA compared with 19% of 129 placebo treated patients. Anti-dsDNA antibodies developed in 17% (261) of patients compared with none in 162 placebo-treated patients. Similarly, in trials of adalimumab for treatment of rheumatoid and psoriatic arthritis, 11.9% of patients treated with active drug and 8.1% of placebo and active control treated patients that had negative baseline antinuclear antibody titres reported positive ti-tres at week 24. However, only two patients of 3989 treated with adalimumab in all rheumatoid and psoriatic arthritis, and ankylos-ing spondylitis studies developed clinical signs suggestive of new onset lupus-like syndrome. On the other hand, other studies have estimated the prevalence of the development of drug-induced lupus due to TNF inhibitors at between 0.1 and 1.6%. The impact of long-term treatment with TNF-inhibitors on the development of autoimmune diseases, therefore, remains unknown, although it appears that, despite the higher incidence of autoantibodies, clinical manifestations of disease are uncommon, generally mild and respond to withdrawal of the drug. Possible reasons for the findings will be discussed.

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