Genentech, Inc. and XOMA Ltd. today announced positive results from a randomized Phase III clinical trial with RaptivaTM
(efalizumab) that studied efficacy and safety in the treatment of adults with moderate-to-severe plaque psoriasis. The study results were presented by Kenneth Gordon, M.D., Associate Professor of Medicine, Division of Dermatology at Loyola University in Chicago, Illinois during a session on emerging biologic therapies for psoriasis at the 61st annual American Academy of Dermatology (AAD) meeting in San Francisco.
Results from the 556-patient, placebo-controlled study were consistent with data obtained from previous Phase III Raptiva studies and were included as part of a Biologics License Application (BLA) to the U.S. Food and Drug Administration and are currently under review.
After 12 weeks of Raptiva therapy, 27 percent (98/369) of study patients demonstrated 75 percent or greater Psoriasis Area and Severity Index (PASI) score improvement, versus 4 percent (8/187) of patients on placebo, and 59 percent (216/369) achieved 50 percent or greater PASI score improvement, versus 14 percent (26/187) in the placebo group.
"Our extensive clinical experience with Raptiva in three randomized Phase III trials and a long-term open-label trial demonstrate that patients experience clinically meaningful response with rapid onset of effect," said Hal Barron, M.D., FACC, Genentech's vice president, Medical Affairs. "We believe that these efficacy results combined with the emerging safety profile in more than 2,100 Raptiva-treated patients contribute to a favorable overall clinical profile for Raptiva as a potential once-weekly treatment for moderate-to-severe psoriasis."
Data from 15 months of an open-label multicenter trial evaluating the safety and tolerability of Raptiva as a potential continuous treatment in patients with moderate-to-severe psoriasis will be presented by Alice Gottlieb, M.D., Page: 1 2 3 4 5 Related biology news :1
Contact: Emmy Tsui
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