Study design meta-analysis description

MENSA/MUSCA Meta-Analysis Description

Meta-analysis description
Post hoc meta-analysis of two clinical studies with NUCALA (MENSA and MUSCA) in patients ≥12 years of age with severe eosinophilic asthma (SEA).2,9 The purpose was to assess NUCALA vs placebo on the annual rate of exacerbations at the end of the treatment period for each study in select subgroups, including the presence of nasal polyps and atopic status.

MENSA Study Design and Primary Endpoint1

Study Description
32-week, multicenter, randomized, double-blind, double-dummy, placebo-controlled study comparing treatment with NUCALA or mepolizumab 75 mg IV placebo, each added to standard of care (SOC) in 576 patients ≥12 years of age with SEA, identified by blood eosinophil counts of ≥150 cells/µL at baseline or ≥300 cells/µL within the last 12 months.

Primary Endpoint/Results
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

MUSCA Study Design and Primary Endpoint2,7

Study Description
24-week, multicenter, randomized, double-blind, placebo-controlled study comparing treatment with NUCALA to placebo, each added to SOC, in 551 patients ≥12 years of age with SEA, identified by blood eosinophil counts of ≥150 cells/µL at baseline or ≥300 cells/µL within the last 12 months.

Primary Endpoint/Results
Mean change from baseline in St. George’s Respiratory Questionnaire (SGRQ) total score at Week 24. -15.6 for NUCALA vs -7.9 for placebo; treatment difference of -7.7 (P<0.0001). The improvement in both treatment arms was clinically meaningful.

Defined as a reduction in score of 4 points or more for minimal clinically important difference.5

IV=intravenous.