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| |  AAD: Second Course Of Alefacept Provides Continued Response Against Chronic Plaque Psoriasis By Ed Susman Special to DG News
ANAHEIM, CA -- July 30, 2001 -- The experimental biotechnology drug alefacept appears to maintain treatment advances during a second course of therapy in treating chronic plaque psoriasis, researchers say. Alefacept is designed to be delivered by intermittent therapy. The human LFA-3/imunoglobulinG-1 fusion protein is manufactured by Biogen of Cambridge, Massachusetts. "Clinical response to alefacept was consistent among patients who received two courses of therapy," said Dr. Debra Breneman, MD, clinical director of research and associate professor of dermatology at the University of Cincinnati, in Ohio. "Continued clinical improvement occurred after each treatment course, as was observed in the randomized phase II trial." Dr. Breneman, in reporting her study at the summer scientific meeting of the American Academy of Dermatology, said the goal of the trial was to determine the tolerability and efficacy of repeated courses of alefacept in patients with chronic plaque psoriasis and the trial was designed as an open-label, multicenter Phase II study. The patient population for her trial were those patients who finished the 12-week follow-up assessment of the phase II dose-finding or dose-ranging trials. Patients were assessed monthly for disease progression and alefacept was re-started when the investigator determined that systemic therapy was required. The doctor said the study represents an ongoing trial in which 174 patients have received at least one dose of the alefacept; of those patients 107 have received two courses of treatment; 23 have received a third dose. One hundred and seventy patients who took one dose were available for evaluation; 50 patients who have completed two courses of treatment are also available for evaluation. Patients who received the first dose of alefacept experienced an average of a 47 percent decline in the Psoriasis Area and Severity Index (PASI); while those on the second course of treatment were able to maintain those results three months following discontinuation of the second treatment dose. Dr. Breneman said there were no reports of disease rebound, a condition where a patient's psoriasis becomes substantially more severe than at baseline once treatment is withdrawn. Alefacept is a disease-modifying agent with a highly selective mode of action targeting a subset of T-cells - the memory effector T-cells - that play a critical role in the pathogenesis of psoriasis. Earlier Phase II trials yielded promising results including remission in some patients without rebound. To date more than 1,500 people have been treated with the drug which is administered by a 30-second intravenous bolus injection once a week for 12 weeks. A course of therapy with alefacept is defined at the 12 weeks of treatment followed by 12 weeks of observation. Adverse effects with alefacept in the re-treatment trial were similar to those seen in the original Phase II trials, Dr. Breneman reported. "Multiple courses were well tolerated," she said, "with no increased risk of infection."
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