"The findings from this important open-label study on the long-term safety and efficacy of Raptiva are very encouraging and further support Raptiva's potential to address the unmet medical need of patients with moderate-to-severe psoriasis," said Hal Barron M.D., FACC, Genentech's vice president, Medical Affairs.
Alice Gottlieb, M.D., director of the Clinical Research Center at the Robert Wood Johnson Medical School at the University of Medicine and Dentistry of New Jersey presented data for patients receiving continuous Raptiva treatment for one year following an initial three months of treatment. The data were presented on Saturday, March 22 at the 61st annual American Academy of Dermatology meeting being held in San Francisco.
Response Rates with Continued Raptiva Treatment
A total of 339 patients were enrolled in this continuing open-label, multicenter study. 41 percent of patients (140/339) achieved 75 percent or greater improvement in Psoriasis Area and Severity Index (PASI) scores (PASI 75) and 82 percent (278/339) achieved PASI 50 or greater improvement after 12 weeks of 2 mg/kg/week Raptiva therapy. Patients who achieved a PASI 50 score or OLS (Overall Lesion Severity scale) of clear, minimal or mild at week 12 were eligible to enter the continuous treatment period. Of the original 339 patients, 290 patients who met the entry criteria for the maintenance period entered the continuous treatment phase of the study. For each successive three-month period of treatment, dropouts during that cohort period were counted as non-responders for that cohort, but were excluded from the subsequent cohorts.