The focus of this study was to investigate the efficacy of etanercept for the treatment of psoriatic arthritis (PsA), an open-label follow-up to a 12 week placebo controlled study by Mease, et al.

Methods: 205 patients with PsA having > 3 each swollen and tender joints were randomized to receive 25 mg etanercept (n=101) or placebo (n=104). Background Methotrexate (< 25 mg) use was permitted. ACR 20, PsA Response Criteria (PsARC), target lesion score, and in a subset of patients, the psoriasis area and severity index (PASI) were used to measure arthritis severity.

Results: By week 12, 59% of patients in the etanercept group had achieved ACR 20 compared with only 15% of patients in the placebo group (p<0.001). By week 24, the median improvement in the target lesion was 33% in the etanercept group compared with 0% in the placebo group (p<0.001). The median improvement in PASI was 47% in the etanercept group (n=66) compared with 0% in the placebo group (n=62) (p<0.001).

Conclusions: Etanercept was generally well tolerated, although there was one case of multiple sclerosis in the etanercept group. These data indicate that etanercept is safe and effective for treatment in patients with psoriatic arthritis.

Editorial Comment: This Phase III study shows much the same results as the smaller preliminary Phase II trial. Concomitant Methotrexate did not affect the response differences between etanercept and placebo groups. The FDA has approved etanercept for the treatment of psoriatic arthritis.

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