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Preliminary Study Results Demonstrate Continuous, Weekly Dosing of Efalizumab Provides Sustained Clinical Benefit Over 30 Months
Of the 159 subjects participating in the study who completed 30 months of treatment, a 75 percent or greater improvement on the Psoriasis Area Severity Index (PASI 75) was observed in 78 percent (124/159) of patients with weekly RAPTIVA therapy. Ninety-one percent (145/159) of patients achieved a PASI 50 response, and 45 percent of patients (71/159) achieved a 90 percent or greater PASI improvement (PASI 90).
"Given that psoriasis is a chronic condition, dermatologists are looking for treatment options that can provide these patients with continuous control of their disease over the long-term," said Craig Leonardi, M.D., associate clinical professor of dermatology at St. Louis University Medical School, St. Louis, Mo., and a study investigator. "These data represent the first 30-month data available for any advanced therapy for plaque psoriasis and support the continued use of RAPTIVA as an important treatment option for patients afflicted with this chronic disease."
In this study, 339 patients received RAPTIVA weekly for an initial 12 weeks and patients with a PASI 50 response or a static Physician's Global Assessment response of 'mild' or better after 12 weeks of treatment were eligible to continue on a once-weekly maintenance dose of 1mg/kg RAPTIVA for 12-week periods starting at week 13. Of the 339 subjects who started the study, 290 qualified for continued treatment beyond 12 weeks. 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.
"Since RAPTIVA was launched in November 2003, this novel therapy has been widely embraced by dermatologists and patients," said Ivor Caro, M.D., Genentech's medical director of dermatology. "These 30-month data give dermatologists additional insight into how RAPTIVA may be used to develop long-term treatment strategies for their moderate-to-severe plaque psoriasis patients."
Adverse events in this study were similar to what has been observed in previous clinical trials of RAPTIVA, and include headache, non-specific infection (e.g., common colds), chills, pain, nausea, asthenia (weakness), and fever, all of which diminished after the first 1-2 doses. Further, there was no evidence of accumulation or cumulative toxicity. At 30-months, the occurrence of serious adverse events was infrequent which is consistent with data from previous RAPTIVA Phase III studies.
RAPTIVA(R) (efalizumab) is a humanized therapeutic antibody designed to selectively and reversibly block the activation, reactivation and trafficking of T-cells that lead to the development of psoriasis. In October 2003, RAPTIVA received U.S. Food and Drug Administration approval for the treatment of chronic moderate-to-severe plaque psoriasis in adults 18 years or older who are candidates for systemic therapy or phototherapy. The recommended dose of RAPTIVA is a single 0.7 mg/kg SC conditioning dose followed by weekly SC doses of 1 mg/kg.
RAPTIVA is the first and only FDA approved biologic therapy that is designed to provide continuous control of chronic moderate-to-severe plaque psoriasis and can be self-administered by patients as a single, once-weekly, subcutaneous injection. In clinical studies, RAPTIVA demonstrated a rapid onset of action in the reductions of symptoms associated with psoriasis, in some patients within four weeks of initial treatment. More than 3,500 patients in the United States and Europe have been included in RAPTIVA trials to date, creating the largest existing database of patients taking part in studies with a biological therapy for psoriasis.
For full prescribing information, please visit www.raptiva.com.
Important Safety Information
Common adverse events that occurred at least two percent more frequently in RAPTIVA patients than in placebo included headache, infection (mostly upper respiratory infections), chills, nausea, pain, myalgia (muscle pain), flu syndrome, fever, back pain, and acne. Five of these events (headache, chills, fever, nausea and myalgia) were predominantly acute adverse events and were principally seen following the first two injections of RAPTIVA. For the third and subsequent doses, the incidence of acute adverse events was similar between the RAPTIVA and placebo groups. Less than one percent of patients were discontinued from treatment due to acute adverse events.
RAPTIVA is an immunosuppressive agent and has the potential to increase the risk of infection and reactivate latent, chronic infections. Many immunosuppressive agents have the potential to increase the risk of malignancy. The role of RAPTIVA in the development of malignancies is not known. Serious adverse events occurring in clinical studies with RAPTIVA were serious infections (0.4% in RAPTIVA vs. 0.1% in placebo), malignancy (the overall incidence of malignancies of any kind was 1.8 per 100 patient-years for RAPTIVA-treated patients compared with 1.6 per 100 patient-years for placebo-treated patients), thrombocytopenia (0.3% RAPTIVA vs. 0.0% placebo), and worsening of psoriasis, typically upon discontinuation (0.7% in RAPTIVA vs. 0.0% in placebo).
Psoriasis occurs when new skin cells grow abnormally, resulting in thick, red, scaly, inflamed patches. Plaque psoriasis, the most common form of the disease, affects approximately 2.3 million Americans and is characterized by inflamed patches of skin ("lesions") topped with silvery white scales. Psoriasis can be limited to a few spots or involve extensive areas of the body, appearing most commonly on the scalp, knees, elbows and trunk. Although it is highly visible, psoriasis is not a contagious disease. While there are a number of medications that may help control the symptoms of psoriasis, there currently is no known cure.
Source: Genentech and Xoma