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Study Descriptions

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STUDY DESCRIPTION
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 care (SOC) in 576 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.

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

REALITI-A Real-World Study2

Real-world studies are designed to evaluate associations among variables and not to definitively establish causality. These limitations are important when interpreting results: lack of comparator arm; differences in patient populations and data collection vs randomized controlled trials.

INTERIM ANALYSIS
These data are a prespecified interim analysis of 368 patients who completed 12 months of follow-up. This analysis may not reflect the results from the final dataset.

DESCRIPTION
Ongoing, 2-year, prospective, multinational, single-arm, observational cohort study assessing the real-world effectiveness and pattern of use of NUCALA 100 mg every 4 weeks in adult patients with SEA who met the eligibility requirements to initiate NUCALA. Data were collected prospectively at usual asthma healthcare visits. A 12-month period of relevant medical data was required prior to enrollment and collected retrospectively. Baseline visit was first administration of NUCALA.

OBJECTIVES
Assessed 12‑month post‑treatment period vs 12-month pre-treatment period (baseline); Primary: exacerbation rate; Secondary: maintenance OCS use.

Defined as deterioration in asthma requiring use of systemic corticosteroids and/or an ED visit and/or hospital admission.2

COLUMBA (4.5-year open-label study)2,3

STUDY DESCRIPTION
4.5-year, multicenter, open-label, long-term study assessing the safety, immunogenicity, and efficacy of NUCALA in 347 patients ≥12 years of age with SEA previously treated in DREAM at least 12 months prior and met eligibility criteria. All patients received NUCALA added to asthma controller therapy.

PRIMARY ENDPOINTS/RESULTS
Long-term safety, including adverse events (AEs), serious adverse events (SAEs), and immunogenicity. Most frequent AEs (≥20%): viral upper respiratory tract infection, 49%; headache, 29%; asthma§, 27%; upper respiratory tract infection, 23%; bronchitis, 21%. Two SAEs occurred in ≥1% of patients: asthma, 10%; and pneumonia, 2%. A total of 8% of patients had a positive anti-drug antibody result, but all were negative for neutralizing antibodies.

SECONDARY ENDPOINTS/RESULTS
Frequency of exacerbations||, asthma control (ACQ-5 score), and lung function (FEV1). Exacerbations: The annualized exacerbation rate was 0.68 (95% CI; 0.60 to 0.78). Asthma Control: The mean change from baseline in ACQ-5 score was -0.47 points at both Week 12 and end of study. Lung Function: The mean change from baseline in pre-bronchodilator FEV1 at Week 12 was 124 mL, and gradually declined to approximate baseline values at end of study.

Results are descriptive.

DREAM: 52-week study comparing mepolizumab IV to placebo IV added to SOC in 616 patients ≥12 years of age with severe asthma. Primary Endpoint/Results: Exacerbations/year 1.24 for mepolizumab 75 mg vs 2.40 for placebo (48% reduction, P<0.0001).4
§Asthma reported as an AE means worsening or exacerbation of asthma.
||Exacerbations of asthma were defined as the worsening of asthma that required use of oral/systemic corticosteroids and/or hospitalization and/or 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.

ACQ=Asthma Control Questionnaire; FEV1=forced expiratory volume in 1 second; IV=intravenous.