A 12-week open-label followed by 4-week double-blind study to determine the safety and efficacy of an extended course of alefacept (LFA-3/igg1 fusion protein) in subjects with chronic plaque psoriasis

Abstract

Psoriasis is a common dermatologic disorder both in Europe and the United States, affecting approximately 2% of the population. Over one million of these patients require ultraviolet (UV) light or systemic therapies, all of which are associated with substantial risks. Activation of T lymphocytes has been implicated as part of the pathologic process in psoriasis. Cell surface expression levels of both CD2 and LFA-3 have a regulatory role in activating and inducing proliferation of T lymphocytes. Alefacept, a fusion protein consisting of the Fc portion of human IgG1 linked to LFA-3, has been recently approved by the United States Food and Drug Administration for the treatment of psoriasis. Previous studies with Alefacept have provided experience with the efficacy, tolerability, and immunogenicity of single and multiple 12-week courses of therapy. To date, studies, as well as the FDA-approved labeling for weekly intramuscular or intravenous injection, have been confined to treatment courses of 12 weeks. The purpose of this present study is to determine the safety and efficacy of an extended course of alefacept when administered to subjects with chronic plaque psoriasis.