WAIKOLOA, HAWAII — Alefacept, the first biologic agent to gain approval for treatment of psoriasis, still has a limited role to play.
“About one in nine patients will have a home run with this drug. They have … sustained remission for a long period after the last of their 12 weekly shots,” said Dr. Boni E. Elewski, professor of dermatology at the University of Alabama at Birmingham. But there is no way to predict which patients will be the big responders, she told the annual Hawaii dermatology seminar sponsored by Skin Disease Education Foundation.
Even those who don't hit a home run with alefacept (Amevive) can gain substantial benefit. The drug, a fully human fusion protein that inhibits T-cell activation and selectively reduces activated memory T cells, works slowly in clearing psoriasis but can bring further improvement for weeks after the last dose. Subsequent courses of alefacept may result in longer remission periods.
On the downside, the response rate is lower than with the anti-tumor necrosis factor-α drugs. In a phase III trial, 21% of 166 patients had at least a 75% reduction in Psoriasis Area and Severity Index (PASI) scores 2 weeks after their 12th dose of alefacept (15 mg IM). And 42% had at least a 50% reduction in PASI.
The safety profile of alefacept is quite favorable. Unlike other biologics approved for psoriasis, it isn't associated with opportunistic infections, heart failure, demyelinating diseases, psoriasis rebound, or reactivation of tuberculosis after the completion of treatment.
Dr. Elewski reserves the drug for psoriasis patients with relative contraindications or sensitivity to anti-TNF agents: those with a personal history of melanoma, an internal malignancy, heart failure, or systemic lupus erythematosus, or a personal or family history of multiple sclerosis or another demyelinating disease. “I don't give anti-TNF drugs in any patient who has had melanoma. Before I start a patient on a biologic, I look at their skin from head to toe for any atypical moles and I check for nonmelanoma skin cancer before and during biologic therapy.”
The out-of-pocket expense for alefacept under Medi- care Part D is at least $5,000. Patients who can't afford it are often ineligible for foundation assistance because they have Medicare. Astellas Pharma U.S. Inc., the manufacturer of alefacept, has formed the Amevive Start Assistance Program (866-263-8483) to help patients.
Dr. Elewski is a consultant to and/or investigator for Astellas, Amgen Inc., and Centocor Inc.
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