Genentech Announces Positive Results from a Phase IV Study of Raptiva in Patients With Moderate-to-Severe Hand and Foot Psoriasis
- Category: Antibodies
- Published on Monday, 05 February 2007 02:00
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WASHINGTON, DC, USA | Feb 02, 2007 | Genentech, Inc. (NYSE: DNA) today announced results from a Phase IV study of Raptiva® (efalizumab) that showed statistically significant improvement in patients with chronic moderate-to-severe plaque psoriasis involving the hands and feet. The 12-week study is the first randomized, double blind, placebo-controlled trial to evaluate a biologic agent in the treatment of this uniquely challenged subpopulation of psoriasis patients. The results were presented as a poster at the 65th annual meeting of the American Academy of Dermatology in Washington, D.C.
"Plaque psoriasis on the hands and feet has been historically difficult to treat and poses unique challenges to a patient's life from the simple act of a handshake to the potentially crippling effect on a patient's ability to walk and even wear shoes comfortably," said Craig Leonardi, M.D., associate clinical professor of Dermatology at St. Louis University Medical School, St. Louis, Mo., and the study's lead investigator. "These data support Raptiva as an effective treatment option for this patient population."
Study Design and Key Findings
The primary endpoint of this study was to evaluate the efficacy of Raptiva, defined as the attainment of a Physician's Global Assessment (PGA) rating of clear (0), almost clear (1), or mild (2) at the end of a 12-week treatment period.
Eligible adult patients with chronic moderate-to-severe plaque psoriasis of the hands and/or feet were randomized 2:1, with 52 patients receiving a once-weekly dose of 1mg/kg of subcutaneous Raptiva and 28 patients receiving placebo for 12 weeks.
Of the 80 patients who were randomized into the study:
* Approximately 46 percent (24/52) of patients in the Raptiva group received a PGA rating of clear (0), almost clear (1), or mild (2), compared to 18 percent (5/28) of patients in the placebo group (p=0.015).
A secondary endpoint defined as the attainment of a PGA rating of clear (0) or almost clear (1) at the end of the same 12-week period was also assessed. Of the 80 patients who were randomized into the study:
* Approximately one third (33 percent or 17/52) of patients receiving Raptiva were clear (0) or almost clear (1), compared to 7 percent (2/28) in the placebo arm (p=0.013).
Adverse events in this study were consistent with previous company-sponsored clinical trials with Raptiva. Serious adverse events (SAE) observed in this study included gastrointestinal hemorrhage and lacunar infarction in one patient receiving Raptiva and one serious infection reported in a patient receiving placebo. None of these SAEs were considered to be related to the study drug. Serious adverse reactions observed in previous experience with Raptiva are serious infections, malignancies, thrombocytopenia, hemolytic anemia, arthritis events, and psoriasis worsening and variants.
Disease severity in plaque psoriasis is typically measured by the percentage of body surface covered by psoriasis plaques and what parts of the body are affected. Hand and foot psoriasis can have a significant impact on a patient's ability to conduct routine daily activities, and the American Academy of Dermatology categorizes the disease as severe if these areas are affected.
Raptiva® (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. Raptiva can be self-administered by patients as a single dose, once-weekly, subcutaneous injection after proper training by a healthcare professional.
Important Safety Information
The most common adverse reactions associated with Raptiva were a symptom complex that included headache, chills, fever, nausea, and myalgia within 48 hours following the first 2 injections. These events were largely mild to moderate when a first dose of 0.7 mg/kg was given. Less than 1 percent of patients discontinued Raptiva treatment because of these adverse events.
The most serious adverse reactions observed during treatment with Raptiva were serious infections, malignancies, immune-mediated thrombocytopenia, immune-mediated hemolytic anemia, arthritis events, and psoriasis worsening and variants. Serious infections and immune-mediated thrombocytopenia have been reported during post-marketing surveillance. Physicians should follow patients for signs and symptoms of thrombocytopenia; platelet monitoring is recommended. Acellular, live, and live-attenuated vaccines should not be administered during Raptiva treatment.
For full prescribing information, please visit http://www.RAPTIVA.com or call 877-RAPTIVA.
Psoriasis occurs when new skin cells grow abnormally, resulting in thick, red, and 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.
About Genentech's Commitment to Patient Access
Genentech is committed to eligible patients having access to our therapies. For those eligible patients treated for approved indications in the United States who do not have insurance or who cannot afford their out-of-pocket co-pay costs, Genentech has several support programs. Since 1985, Genentech has donated free product to uninsured patients and those deemed uninsured due to payor denial through its Genentech® Access to Care Foundation (GATCF) and the Genentech Endowment for Cystic Fibrosis. In 2006 alone, GATCF supported over 14,000 patients by providing approximately $205 million of free product. Since 2005, Genentech has donated approximately $70 million to various independent public charities that provide financial assistance to eligible patients who cannot access needed medical treatment due to co-pay costs. Through its Single Point of Contact (SPOC) program, Genentech provides patients with assistance and information on a broad array of reimbursement services and support.
Founded 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes biotherapeutics for significant unmet medical needs. A considerable number of the currently approved biotechnology products originated from or are based on Genentech science. Genentech manufactures and commercializes multiple biotechnology products and licenses several additional products to other companies. The company has headquarters in South San Francisco, California and is listed on the New York Stock Exchange under the symbol DNA. For additional information about the company, please visit http://www.gene.com.
SOURCE: Genentech, Inc