Post hoc meta-analysis of two clinical studies with NUCALA (Trial 2 and MUSCA) in patients ≥ 12 years of age with SEA.2, 12 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.
Trial 2 (MENSA) design and primary endpoint1
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 SOC in 576 patients of ≥ 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.
Exacerbations*/year 0.83 for NUCALA vs 1.74 for placebo (53% reduction; P<0.001).
MUSCA design and primary endpoint8
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: Mean change from baseline in 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.†
Other endpoint: Exacerbations*/year 0.51 for NUCALA vs 1.21 for placebo, 58% reduction (rate ratio 0.42; 95% CI: 0.31, 0.56).
*Defined as worsening of asthma requiring: systemic corticosteroids or hospitalization or emergency department visit; or at least double the existing maintenance systemic corticosteroid dose for ≥3 days.
SOC=regular treatment with high-dose inhaled corticosteroids (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.2
†Defined as a reduction in score of 4 points or more for minimal clinically important difference.11
CI=confidence interval; IV=intravenous; SEA=severe eosinophilic asthma; SOC=standard of care; SGRQ=St George’s Respiratory Questionnaire.