Genentech Announces Positive Results from a Phase IV Study of Raptiva in Patients With Moderate-to-Severe Hand and Foot Psoriasis
Friday February 2, 1:05 pm ET
- First Study of its Kind in this Difficult-to-Treat Patient Population -
WASHINGTON, Feb. 2 /PRNewswire-FirstCall/ -- Genentech, Inc. (NYSE: DNA - News) 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. |
