Study design and primary endpoint results sirius
SIRIUS Study Design and Primary Endpoint
24-week, multicenter, randomized, double-blind, placebo-controlled study comparing treatment with NUCALA to placebo in 135 patients ≥12 years of age with severe eosinophilic asthma (SEA), identified by blood eosinophil counts of ≥150 cells/µL at baseline or ≥300 cells/µL within the last 12 months. Patients required 5 mg to 35 mg of prednisone or its equivalent per day in addition to regular use of high-dose ICS plus and additional controller. Patients were not required to have a history of exacerbations in the previous 12 months.
Percent reduction in daily OCS dose (Weeks 20 to 24) while maintaining asthma control. NUCALA reduced daily OCS dose while maintaining asthma control vs placebo (P=0.008).
SOC=regular treatment with high-dose inhaled corticosteroids (ICS) (defined as ≥880 μg of fluticasone propionate [FP], or the equivalent, per day in patients ≥18 years of age, and ≥440 μg of FP, or the equivalent, per day in patients 12 to 17 years of age) and at least 1 other controller with oral corticosteroids (OCS).2