The 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 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, almost clear, or mild at the end of a 12-week treatment period.
Of the 80 patients who were randomized into the study, approximately 46% of patients in the Raptiva group received a PGA rating of clear, almost clear, or mild compared to 18% of patients in the placebo group.
A secondary endpoint defined as the attainment of a PGA rating of clear or almost clear at the end of the same 12-week period was also assessed. Of the patients who were randomized into the study approximately one third of patients receiving Raptiva were clear or almost clear, compared to 7% in the placebo arm.