Exacerbation reduction CO
MENSA Study Design and Primary Endpoint
32-week, multicenter, randomized, double-blind, double-dummy, placebo-controlled study comparing treatment with NUCALA or mepolizumab 75 mg IV to placebo, each added to standard of care (SOC) in 576 patients aged ≥12 years with severe eosinophilic asthma, identified by blood eosinophil counts of ≥150 cells/µL at baseline or ≥300 cells/µL within the last 12 months.
Exacerbations*/year 0.83 for NUCALA vs 1.74 for placebo (53% reduction; P<0.001).
- *Exacerbations of asthma were defined as the worsening of asthma that required use of oral/systemic corticosteroids and/or hospitalization and/or emergency department (ED) visits; for patients on maintenance oral/systemic corticosteroids, exacerbations were defined as requiring at least double the existing maintenance dose for at least 3 days.
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 or without oral corticosteroids (OCS).2