Hey George, HERE IS THE REAL STORY>>>>>>>>AAD: Raptiva (Efalizumab) Promising As Long-Term Treatment For Moderate-To-Severe Plaque Psoriasis
CHICAGO, IL -- July 29, 2003 -- Genentech, Inc. (NYSE: DNA) and XOMA Ltd. (Nasdaq: XOMA) announced positive results from two clinical studies evaluating the long-term safety and efficacy of treatment with Raptiva™ (efalizumab) in adults with moderate-to-severe plaque psoriasis. Study investigators presented data from these studies on Monday, July 28 during a peer-reviewed session at the American Academy of Dermatology 2003 meeting in Chicago.
Findings highlighted during the session included data at 24 weeks from an open-label, extended treatment period following the first-time treatment with Raptiva in a randomized, double blind, placebo-controlled Phase III study. By the end of the extended treatment, 44 percent (161/368) of patients treated continuously with 1mg/kg Raptiva for up to 24 weeks achieved a 75 percent or greater improvement in Psoriasis Area and Severity Index (PASI) scores (PASI 75).
Additionally, 21 months (84 weeks) of data from an open-label study evaluating the long-term safety and tolerability of continuous Raptiva will be presented. The 21-month data analysis results showed that 67 percent (130/194) of patients achieved a PASI 75 response with weekly Raptiva therapy.
"These data further support the sustained and potentially increased clinical benefit of Raptiva when administered continuously for the treatment of moderate-to-severe plaque psoriasis," said Hal Barron M.D., F.A.C.C., Genentech's vice president, Medical Affairs.
New Efficacy Data at 24 Weeks of Treatment
Data evaluating efficacy at 24 weeks from an open-label, extended treatment period following 12 weeks of treatment with Raptiva in a randomized, double blind, placebo-controlled Phase III study will be presented. In this study, a total of 368 patients received at least one dose of Raptiva during the first 12 weeks of the study and were eligible to receive once-weekly 1mg/kg doses of Raptiva for an additional 12 weeks.
At week 24, 44 percent (161/368) of patients who had received at least one dose of Raptiva during the first 12 weeks achieved a PASI 75 response. As previously reported, at week 12, 27 percent (98/369) of the patients receiving Raptiva had achieved PASI 75, suggesting an improvement in the reduction of symptoms with continued treatment. Furthermore, at week 24, 67 percent of patients (245/368) achieved a 50 percent or greater PASI improvement (PASI 50) versus 59 percent of patients (216/369) at week 12. Furthermore, 15 percent (55/368) of patients achieved a 90 percent or greater PASI improvement (PASI 90).
No new adverse events emerged during the extended 12 weeks of Raptiva treatment. The most common events that were reported in greater than or equal to five percent of patients included non-specific infection, headache, and arthritis.
"These results show a high percentage of patients experiencing a clinically meaningful response to Raptiva with 24 weeks of continuous therapy," said Kenneth Gordon, M.D., associate professor of Medicine, Division of Dermatology at Loyola University in Chicago, Illinois. "Further, Raptiva continued to be well-tolerated by patients, suggesting a positive overall clinical profile."
Long-Term Study Suggests Continued Benefit with 21 Months of Treatment
Preliminary results at 21 months (84 weeks) from an open-label, multicenter trial evaluating the long-term safety and tolerability of continuous Raptiva treatment will be presented. In this study, patients received 2 mg/kg Raptiva weekly for an initial 12 weeks and subsequently received a once-weekly dose of 1mg/kg Raptiva starting at week 13. For each successive three-month period of treatment, dropouts during that period were analyzed using their last available PASI assessment, but were excluded from the subsequent cohorts. Among the 194 patients who remained in the trial through week 84, 67 percent (130/194) of patients achieved a PASI 75 response and 86 percent (167/194) of patients achieved a PASI 50 response. Furthermore, 34 percent of patients (66/194) achieved a 90 percent or greater PASI improvement (PASI 90).
The most common adverse events during the first 12 weeks of treatment were headache, non-specific infection (e.g., common colds), chills, pain, nausea, asthenia (weakness), and fever, of which headache, chills, nausea, and fever are protocol-defined acute adverse events that mostly occurred following the first two injections of Raptiva. During continuous therapy, the incidence of adverse events decreased over time from 57 percent during weeks 13-24 to 47.9 percent during weeks 73-84. The occurrence of serious adverse events was infrequent, which is consistent with data from previous Raptiva Phase III studies.
About Raptiva
As a targeted T-cell modulator, Raptiva is designed to block the activation of T-cells that cause psoriasis without destroying them. Raptiva has been studied as a once-weekly therapy for the continuous treatment of moderate-to-severe plaque psoriasis. In clinical trials, Raptiva was administered via subcutaneous injection and in several of the trials was self-administered by some patients in their homes. In December 2002, Genentech and XOMA filed a Biologics License Application (BLA) with the U.S. Food and Drug Administration for Raptiva for the treatment of moderate-to-severe plaque psoriasis in patients 18 years or older. More than 2,700 patients have been treated with Raptiva to date, creating the largest existing database of patients treated with a biologic therapy for psoriasis.
Genentech and XOMA are collaborating in the development and commercialization of Raptiva in the United States. Serono S.A., is Genentech's marketing partner outside the United States and Japan.
SOURCE: Ketchum |
