Alefacept in combination with methotrexate for the treatment of psoriatic arthritis: results of a randomized, double-blind, placebo-controlled study

Arthritis and Rheumatism
Philip J MeaseAlefacept in Psoriatic Arthritis Study Group

Abstract

To evaluate the efficacy and safety of alefacept in combination with methotrexate (MTX) for the treatment of psoriatic arthritis (PsA). Patients were eligible for this randomized, double-blind, placebo-controlled trial if they were ages 18-70 years and had active PsA (> or = 3 swollen joints and > or = 3 tender joints) despite treatment with MTX for > or = 3 months (a stable dosage for > or = 4 weeks prior to enrollment). Patients were stratified according to psoriasis body surface area (BSA) involvement (> or = 3% or < 3%). Alefacept (15 mg) or placebo was administered intramuscularly once weekly for 12 weeks in combination with MTX, followed by 12 weeks of observation during which only MTX treatment was continued. The primary efficacy end point was the proportion of patients achieving a 20% improvement in disease activity according to the American College of Rheumatology criteria (an ACR20 response) at week 24. One hundred eighty-five patients were randomly assigned to receive alefacept plus MTX (n = 123) or placebo plus MTX (n = 62). At week 24, 54% of patients in the alefacept plus MTX group achieved an ACR20 response, compared with 23% of patients in the placebo plus MTX group (P < 0.001). Mean reductions in tender and swo...Continue Reading

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