Raptiva data shows continued improvement
First posted July 8, 2003
Researchers presented the impact of efalizumab (brand name Raptiva) spanning 18 months to attendees of the International Psoriasis Symposium in late June 2003.
In the study, 339 patients received Raptiva subcutaneously (under the skin) for three months. After the treatment, those whose PASI scores (a measure of psoriasis severity) improved by 50 percent continued into the maintenance period with half the dose. They will be observed for up to 36 months.
Three months after the initial 12-week treatment, more than 77 percent of patients improved in their PASI scores , and half of the patients improved by 75 percent. More than 22 percent improved by 90 percent.
At month 18, including the initial treatment phase, 67 percent of the patients maintained their 75 percent improvement. Nearly 40 percent maintained 90 percent improvement - nearly 10 percent more than those at 15 months.
"Raptiva is fairly robust when it initiates its response, as early as two weeks," said Craig Leonardi, M.D., associate clinical professor of dermatology at St. Louis University.
The most common side effects during the initial 12-week treatment were chills, pain, nausea, asthenia and fever, with most reactions occurring after the first one or two injections. No new side effects were observed during long-term Raptiva therapy. The number of adverse events decreased over time from 57 percent during months 4 to 6 to nearly 50 percent from months 16 to 18.
Raptiva is a biologic therapy manufactured by Genentech and Xoma. The companies filed in December 2002 with the U.S. Food and Drug Administration for approval for the treatment of moderate to severe psoriasis. Dr. Leonardi, a member of the National Psoriasis Foundation's Medical Board, stated that Genentech hopes to get a U.S. Food and Drug Administration hearing in September 2003 to discuss Raptiva's approval.
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