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| |  AAD: Alefacept (Amevive) Biologic Therapy As Effective In Severe Psoriasis As In Milder Cases By Paula Moyer SAN FRANCISCO, CA -- March 24, 2003 -- Alefacept (Amevive), a biologic agent developed for treatment of psoriasis, is as effective in patients with severe psoriasis as it is in patients with milder disease, according to study findings. The drug is based on a combination of the small molecule human LFA-3 with immunoglobulinG1 through fusion protein, said Barry Ticho, MD, PhD, a staff researcher with Biogen, Inc., the manufacturer of Amevive and study funder. Dr. Ticho participated in two randomised-placebo-controlled phase 3 trials that included 1,000 patients with psoriasis. He reported on those findings here at the 61st Annual Meeting of the American Academy of Dermatology. Patients who participated in these trials had a range of body surface area (BSA) involvement of 6 to 98%. The median BSA was 22 to 24% across the two trials. The median baseline Psoriasis Area and Severity Index (PASI) ranged from 13.2 to 15.2 across the trials. In one trial, the investigators gave subjects 7.5 mg of alefacept, or placebo, intravenously once weekly for 12 weeks. Patients received two courses of therapy with at least a 12-week hiatus between treatments. In the other trial, patients received either 10 or 15 mg of alefacept intramuscularly or placebo, once weekly for 12 weeks, with a 12-week observation period following. The physician global assessment (PGA) considered several factors, including severity, disability, and psychosocial impact. PGA scores showed that more than 80% of patients in these trials had moderate, moderate to severe, or severe disease. Regardless of baseline BSA, PASI, or PGA, the investigators found alefacept to be efficacious, Dr. Ticho said. "More alefacept-treated patients received 75% or greater PASI reduction from the baseline at anytime during treatment or follow-up than those who received placebo," he said. "Among patients with who had a BSA exceeding 30%, 21% responded to alefacept 7.5 mg compared with 5% for placebo in the intravenous study. In the intramuscular study, 30% responded to 15 mg of alefacept compared with 16% for placebo." For patients who had a baseline PASI exceeding 20, 20% responded to 7.5 mg of alefacept in the intravenous study, compared with 3% for placebo. In the intramuscular study, 30% of such patients responded to 15 mg of alefacept and 7% in the placebo arm. Consistent results were observed in those with a baseline PGA of severe or moderate to severe; response to alefacept was 26% and 27% for the IV and IM to sleep respectively, with placebo response rates of 6% in 13%. Because baseline disease severity was similar among the groups in both studies, the investigators pooled the alefacept and placebo groups for additional analyses. For the 25 patients who had a BSA of greater than 30%, the overall response rate was 24.9% for alefacept patients, compared with 10.2% for the placebo patients (n = 108). The response rates for those with less severe disease were 30.8% for the 481 in the alefacept patients and 10.2% for the 245 controls. Less severe disease was defined as having a BSA at or below 30%. "Alefacept was superior to placebo in all analyses that considered baseline disease severity," said Dr. Ticho. "These results are consistent with the original primary efficacy endpoint outcomes of the two phase 3 trials.
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