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Title: Alefacept Effective in Patients with Difficult-to-Treat Psoriasis: Presented at IPS

"Alefacept Effective in Patients with Difficult-to-Treat Psoriasis: Presented at IPS"

By Jill Stein NEW YORK, NY -- June 24, 2003 -- Alefacept is an effective alternative in patients with psoriasis who have limited therapeutic options due to toxicity, comorbidities or a lack of response to other therapies. Enno Christophers, MD, Department of Dermatology, University of Kiel, Germany, presented the findings here June 19th during the Ninth International Psoriasis Symposium, sponsored by the Skin Disease Education Foundation. Dr. Christophers and colleagues used data from two phase III trials of alefacept to determine whether a single course of treatment was effective in patients with psoriasis that did not respond to other psoriasis systemic treatments or phototherapies and patients with contraindications to such treatments. Among a total of 706 patients, 4% to 19% were refractory to one of the major psoriasis therapies, which included methotrexate, cyclosporine, retinoids, long-wave ultraviolet radiation or combined psoralen and long-wave ultraviolet radiation. Half of the pooled phase-III alefacept-treated population had at least one contraindication to existing therapies. Overall, 69% of the alefacept-treated patients were not candidates for at least one of the five major therapies. They all received alefacept at doses of 7.5 mg intravenously (IV), 10 mg intramuscularly (IM), or 15 mg IM once weekly for 12 weeks, followed by 12 weeks of observation per treatment course. Results showed that alefacept was significantly (P<.001) more effective than placebo for the percentage of patients who achieved a Psoriasis Area and Severity Index (PASI) reduction of at least 75% (27% versus 9%, respectively) and a PASI reduction of at least 50% (53% versus 26%, respectively). The researchers also evaluated responses for patients who were considered refractory to or had contraindications to multiple agents and found that 41% were not candidates for at least two therapies, and 21% for at least three therapies. Alefacept was also superior to placebo for these subpopulations. Patients who were refractory to or had contraindications to all five major conventional systemic psoriasis therapies and phototherapy had response rates that ranged from 7% to 11% for a PASI reduction of at least 75%, and from 16% to 32% for a PASI reduction of at least 50% (P<.05). In the alefacept 15-mg group, reductions in circulating memory T cells were consistent across the subpopulations of patients who were refractory to or had contraindications to the other treatments, and were comparable to that of the full study population. Alefacept is a novel biologic agent that inhibits T-cell activation and proliferation and causes selective apoptosis of memory T cells, which are implicated in psoriasis. [Study title: Intramuscular Administration of Alefacept is Safe and Effective in Patients with Chronic Plague Psoriasis: Results of an International Randomized, Double-Blind, Placebo-Controlled, Dose-Comparison Phase III Study. Abstract P581]

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