(EDITED)Well, Here is the press release on Amevive:
It isnt as gloomy as you suggest.(though I concur about safety issues, however they are relative). The therapy is intermittent, appears safer, and is competing against lousy therapies. I say it gets approved, BWTFDIK?
Amevive unveiled: phase III trial results reported
Alefacept, a drug that blocks the interaction of the immune cells that trigger psoriasis, has proven safe and effective for patients with moderate to severe psoriasis in a phase III clinical trial conducted by Biogen, the drug's manufacturer, according to leading clinical investigators.
Mark Lebwohl, M.D., professor and chair of the Department of Dermatology at Mount Sinai School of Medicine of New York University, presented data from the trial today at a symposium. More than 1,000 patients participated in the alefacept (brand name Amevive) phase III trial.
Among patients who received one course of Amevive by intravenous (IV) injection, 28 percent achieved a 75 percent or greater improvement of their psoriasis. Fifty-six percent of patients achieved 50 percent improvement in their disease.
One course of treatment consisted of 12 weekly injections. Importantly, investigators determined there was cumulative benefit from Amevive. After a second 12-week course of treatment, 40 percent of patients achieved a 75 percent or greater improvement of their disease, and 71 percent reached 50 percent improvement.
There was no evidence of toxicity and no psoriasis rebound in patients in the study, according to Dr. Lebwohl. The most frequently reported side effects included headache, itching and flu-like symptoms, but were in small numbers of patients. However, Amevive targets a highly specific immune cell, leaving the rest of the immune system intact. In the presence of the drug, patients were reported to be able to respond normally to other antigens, or "invading foreign molecules."
According to results from a phase II study, remissions lasted an average of 10 months and as long as 18 months, Dr. Lebwohl said. "This is a truly remittive therapy where the benefit seems to be long lasting," he said.
According to Gerald Krueger, M.D., professor of dermatology at the University of Utah School of Medicine, results of a phase II trial suggest that a test at four weeks into the course of treatment may be able to determine which patients will respond to the therapy.
"These therapies are going to be very expensive, and it would be nice to determine who is responsive and who isn't," Krueger said.
Alefacept causes a rapid decline in CD4 T cells, or "memory" T cells, which trigger psoriasis plaques by initiating inflammation and the rapid growth of skin cells.
Biogen is expected to submit Amevive to the U.S. Food and Drug Administration for approval later this year. However, it could take more than a year before the drug actually makes it to the market and becomes available for psoriasis patients. |
