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From the Food and Drug Administration
March 6, 2002

Treatment for Psoriatic Arthritis

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JAMA. 2002;287(9):1103. doi:10.1001/jama.287.9.1103-JFD20003-4-1

The FDA has approved etanercept (Enbrel, Immunex Corp, Seattle, Wash), a dimeric fusion protein, for reducing signs and symptoms of active arthritis in patients with psoriatic arthritis. The drug, an approved treatment for rheumatoid arthritis, can be used in combination with methotrexate in patients who do not respond adequately to methotrexate alone.

The new approval is based on the results of a study in 205 patients with active psoriatic arthritis (≥3 swollen joints and ≥3 tender joints) and plaque psoriasis with a target lesion of at least 2 cm in diameter. Patients could continue their regimen of up to 25 mg/wk of methotrexate. Doses of 25 mg of etanercept or placebo were administered subcutaneously twice a week for 6 months.

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