Efficacy and Quality of Life Data Presented
In the double blind, placebo-controlled, multicenter study, 556 patients were randomized in a 2 to 1 ratio to receive weekly subcutaneous doses of 1 mg/kg Raptiva (n=369) or placebo (n=187) for a 12-week period. The study's primary endpoint was to compare the percentage of patients who achieved 75 percent or greater improvement in PASI scores (PASI 75) after 12 weeks of Raptiva therapy with patients receiving placebo. Secondary endpoints include the percentage of patients who achieved 50 percent or greater improvement in PASI scores (PASI 50); the Overall Lesion Severity scale (OLS), which is a static measure of global physician assessment on psoriasis; patient-reported outcomes such as the Dermatology Life Quality Index (DLQI), which measures impairment from a skin condition, and the Psoriasis Symptom Assessment (PSA).
At week 12, mean improvement in DLQI scores with Raptiva treatment was 47 percent, versus 14 percent for patients on placebo. The study results with Raptiva showed improvement on each of the eight PSA subsets: pain, burning or stinging, itching, bothered by water, irritation, sensitivity, bleeding and scaling.
"The reduction in disease severity and rapid onset of action observed in Raptiva-treated study patients along with the positive impact on these patients' quality of life measurements provide further support for Raptiva as a potential treatment option for psoriasis patients," said Dr. Gordon.
Adverse events that occurred at least 5% more frequently in patients receiving Raptiva compared with those in the placebo group included headache, chills, pain, fever, and myalgia (muscle pain). These events occurred principally following the first two injections of Raptiva.'"/>