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Combination therapy with alefacept and methotrexate for psoriatic arthritis: open label extension of a controlled study

A 12-week, open-label study with a further 12-week observation period examined the efficacy and safety of alefacept (i.m. 15 mg/week) and oral methotrexate 10-25 mg/week in 160 patients with psoriatic arthritis previously treated with these agents in a double-blind, placebo-controlled, randomized study. Patients were maintained on a stable dose of methotrexate (10-25 mg/week). Primary efficacy was measured as a 20% decrease in American College of Rheumatology criteria (ACR20). At the end of week 24, 54% of the 160 patients achieved ACR20. Of these patients, a similar percentage had previously received placebo/alefacept and alefacept/methotrexate. The percentage of patients achieving ACR50 and ACR70 increased from 17 and 7%, respectively, in the double-blind phase to ...