Study design and primary endpoint results sirius

SIRIUS Study Design and Primary Endpoint

SIRIUS8

Study Description
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.

Primary Endpoint/Results
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