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ThursdayMarch 22, 2007SESSION ONE4:00 – 4:20Click here to return to Dermatology Update 2007 Schedule and Abstracts
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Dr. Charles LyndeThis phase IV randomized, double-blind, placebo-controlled study is designed to evaluate the safety and efficacy of subcutaneous (SC) efalizumab in patients with chronic moderate to severe plaque psoriasis involving the hands and/or feet. Efalizumab is a humanized anti-CD11a antibody that has been approved for the treatment of adult patients with chronic moderate to severe plaque psoriasis. Efalizumab has demonstrated safety, efficacy, and quality-of-life improvements in four randomized, placebo-controlled Phase III clinical studies in psoriasis. In addition, in an open-label study, efalizumab showed a sustained efficacy and safety profile with continuous long-term therapy, for up to 3 years. Although psoriasis of the hands and feet involves a relatively small percentage of body surface area, it can have a disproportionate impact on quality of life due to an inability of patients to perform every day activities and to the psychosocial implications of disease in highly visible locations. Case reports suggest that efalizumab appears to be effective in treating this form of psoriasis of the hands and/or feet. This study is designed to further investigate the effect of efalizumab on this type of plaque psoriasis. Patients with psoriasis on other areas of the body are also eligible for this study, so long as they have plaque psoriasis (with or without pustules) that involves the hands and/or feet. Patients in this study must have had no previous exposure to efalizumab. The study is enrolling a total of 75 patients, randomized 2:1 to receive 12 weeks of either SC efalizumab or SC placebo equivalent, and will consist of a screening period (day -14 to day -1), a treatment period day 0 to day 84), and an observation period (day 85 to day 112). The primary efficacy outcome measure is the proportion of patients who achieve a Physician’s Global Assessment (PGA) rating of clear (0), almost clear (1), or mild (2) at Day 84. A secondary endpoint is the proportion of patients who achieve a PGA rating of clear (0), almost clear (1), or mild (2) at day 42. Safety will be assessed by the incidence of adverse events (AEs), including infections, serious adverse events (SAEs), and the incidence of treatment-emergent laboratory abnormalities. In this presentation, we report the patients’ baseline characteristics, and the observed efficacy and safety outcomes during the trial. Click here to return to Dermatology Update 2007 Schedule and Abstracts |