An International, Randomized, Double-Blind, Placebo-Controlled Phase Iii Dose-Comparison Study To Evaluate Weekly Intramuscular Administration Of Alefacept In Patients With Chronic Plaque Psoriasis

Alefacept is a novel selective immunomodulating agent (SIMA). The present study evaluated the efficacy and safety of alefacept compared with placebo given once weekly as an intramuscular (IM) injection of either 10 or 15 mg for 12 weeks to patients with chronic plaque psoriasis. Alefacept 15 mg provided highly significant improvements in all measures of psoriasis disease activity compared with placebo. Pharmacodynamic data confirmed that alefacept reduces memory-effector T cells, the source of the pathogenic mediators of psoriasis. Alefacept was well tolerated, with adverse events similar to placebo. These findings demonstrate the efficacy and safety of alefacept by IM administration, an alternative route of administration to the intravenous (IV) formulation that is also under clinical development for psoriasis.