Amevive study shows some muscle
First posted July 1, 2003
One-third of patients with moderate to severe psoriasis improve by 75 percent and maintain significant improvement for seven months after a 12-week course of Amevive, according to Biogen. The company announced the results in New York in June at the International Psoriasis Symposium.
"The standout here is the duration of remission," said Mark Lebwohl, M.D., professor and chairman of the Mt. Sinai School of Medicine of New York University and a member of the Psoriasis Foundation�s Medical Board. The finding is significant because most psoriasis treatments do not result in such remission times.
Biogen announced its latest data for Amevive by intramuscular injection (IM); previous data only showed efficacy and safety for intravenous injection (IV). The data were from an on-going analysis of information from Phase III clinical trials.
Patients with moderate to severe psoriasis were given one 12-week course of Amevive delivered through IM. Those whose psoriasis decreased by 75 percent maintained improvement for 7 months. The data is consistent with results from intravenous administration.
More than 500 patients were involved in the study. For their first course of Amevive, patients split into three groups and were given different dosages: 15 milligrams (mgs), 10 mg or placebo once weekly. Each group was observed for 12 weeks, and then continued into a second course.
In the 54 patients who improved by 75 percent, at least 50 percent improvement was sustained for a median duration of 208 days. Among those who achieved "clear" or "almost clear," the median duration of response was 245 days.
Side effects, including headache, accidental injury and sore throat, were of similar frequency between the treated and placebo groups, said Dr. Lebwohl.
However, Dr. Lebwohl stressed the need to alert patients to the slower onset of remission. "Patients will find that alefacept works slowly and gradually. Some don't achieve response until weeks after the last dose," he said.
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