Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Benepali

Benepali 50 mg solution for injection in pre-filled syringe Benepali 50 mg solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 45

HOS-222652 · Präparat HOS-217048

Autoantibodies Adult patients had serum samples tested for autoantibodies at multiple timepoints. Of the rheumatoid arthritis patients evaluated for antinuclear antibodies (ANA), the percentage of patients who developed new positive ANA (≥ 1:40) was higher in patients treated with etanercept (11%) than in placebo- treated patients (5%). The percentage of patients who developed new positive anti-double-stranded DNA antibodies was also higher by radioimmunoassay (15% of patients treated with etanercept compared to 4% of placebo-treated patients) and by Crithidia luciliae assay (3% of patients treated with etanercept compared to none of placebo-treated patients). The proportion of patients treated with etanercept who developed anticardiolipin antibodies was similarly increased compared to placebo- treated patients. The impact of long-term treatment with etanercept on the development of autoimmune diseases is unknown.

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