Findings from a recently completed Phase II study show that patients with active psoriatic arthritis who received Biogen Idec's Amevive (alefacept) achieved significant improvement in disease. Patients treated with Amevive also experienced less progression of disease, as measured by radiographic assessment, than placebo-treated patients after 24 weeks.
In the study, patients received two treatment courses. In the double-blind, placebo-controlled first course, 185 patients with active psoriatic arthritis were randomized to receive either methotrexate and Amevive or methotrexate and placebo. Patients in the Amevive group received 15 mg of the drug by intramuscular injection once a week for 12 weeks, followed by a 12-week observation period. After the first treatment course, an open-label, non-placebo-controlled second course was administered in which all patients received Amevive and methotrexate once a week for 12 weeks, followed by a 12-week observation period. Results were measured at week 48 of the study, 12 weeks after the last dose of the open-label second course.
New findings presented show that the progression of joint damage, evaluated after 24 weeks, was delayed in subjects receiving Amevive and methotrexate in the placebo-controlled portion of the study (first course) compared with placebo and methotrexate. The mean change from baseline at six months was 0.3 in the treatment arm, versus 1.3 in the placebo arm.