Enbrel

[etanercept]

Immunogenicity

Patients with RA, psoriatic arthritis, ankylosing spondylitis, or plaque psoriasis were tested atmultiple time points for antibodies to ENBRELŪ. Antibodies to the TNF receptor portion or otherprotein components of the ENBRELŪ drug product were detected at least once in sera of approximately 6% of adult patients with RA, psoriatic arthritis, ankylosing spondylitis or plaque psoriasis. These antibodies were all non-neutralizing. No apparent correlation of antibody development to clinical response or adverse events was observed. Results from JRA patients were similar to those seen in adult RA patients treated with ENBRELŪ. The long-term immunogenicityof ENBRELŪ is unknown.

The data reflect the percentage of patients whose test results were considered positive for antibodies to ENBRELŪ in an ELISA assay, and are highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody positivity in an assaymay be influenced by several factors including sample handling, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to ENBRELŪwith the incidence of antibodies to other products may be misleading.

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Autoantibodies

Patients with RA had serum samples tested for autoantibodies at multiple time points. In RA Studies I and II, the percentage of patients evaluated for antinuclear antibodies (ANA) whodeveloped new positive ANA (titer = 1:40) was higher in patients treated with ENBRELŪ (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 ENBRELŪ compared to 4% of placebo-treated patients) and by Crithidia luciliae assay(3% of patients treated with ENBRELŪ compared to none of placebo-treated patients). The proportion of patients treated with ENBRELŪ who developed anticardiolipin antibodies was similarly increased compared to placebo-treated patients. In Study III, no pattern of increased autoantibody development was seen in ENBRELŪ patients compared to MTX patients.

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