Tables
- Table 1
Key study characteristics and methods
Characteristic METREX METREO Population All patients receiving ≥1 dose of mepolizumab or placebo Patients with blood eosinophils ≥150 cells·μL−1 at screening or ≥300 cells·μL−1 Patients with blood eosinophils ≥150 cells·μL−1 at screening or ≥300 cells·μL−1 Intervention 1 Mepolizumab 100 mg s.c. (n=417) Mepolizumab 100 mg s.c. (n=233) Mepolizumab 100 mg s.c. (n=223) Intervention 2 Mepolizumab 300 mg s.c. (n=225) Control Placebo (0.9% saline) s.c. (n=419) Placebo (0.9% saline) s.c. (n=229) Placebo (0.9% saline) s.c. (n=226) Key inclusion criteria COPD diagnosis: history of COPD for ≥1 year in accordance with the definition provided by the American Thoracic Society/European Respiratory Society [17] FEV1 to FVC ratio <0.70 before and after bronchodilator use and a post-bronchodilator FEV1 >20% and ≤80% of the predicted value ≥2 moderate COPD exacerbations (use of systemic corticosteroids and/or treatment with antibiotics) or ≥1 severe COPD exacerbation (required hospitalisation) Triple inhaled therapy for at least 12 months prior to screening including 3 months of an ICS at dose ≥500 μg·day−1 fluticasone propionate dose equivalent, plus LABA and LAMA; or must be taking for 12 months prior to screening (but not in 3 months immediately prior) ICS plus LABA or LAMA and a phosphodiesterase-4 inhibitor, methylxanthine, or a combination of short-acting β2-agonist and short-acting muscarinic antagonist ≥40 years of age at screening Confirmed COPD with no restrictions on smoking status (smoker, nonsmoker, never-smoker) Key exclusion criteria Current diagnosis of asthma Previous history of asthma in never-smokers Other respiratory disorders, including α1-antitrypsin deficiency, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, primary pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases Pneumonia, exacerbation, lower respiratory tract infection within 4 weeks prior to screening Other conditions causing elevated eosinophils or parasitic infection Randomisation Computer-generated, permuted block Analysis Intention-to-treat Primary end-point Yearly rate of moderate to severe exacerbations Secondary end-points Time to first exacerbation Emergency department visits Hospitalisation Average yearly change in St George's Respiratory Questionnaire score Average yearly change in COPD Assessment Test score Pre-specified meta-analysis Blood eosinophil stratification based on the following thresholds: <150 and a history of ≥300 cells·μL−1 in the previous year; ≥150 to <300 cells·μL−1; ≥300 to <500 cells·μL−1; and ≥500 cells·μL−1 Post hoc meta-analysis Blood eosinophils <150 cells·μL−1, blood eosinophils ≥300 cells·μL−1 Effect of mepolizumab compared to placebo on moderate/severe exacerbations treated with glucocorticoids (alone or in addition to antibiotics), or those treated with antibiotics alone FEV1: forced expiratory volume in 1 s; FVC: forced vital capacity; ICS: inhaled corticosteroid; LABA: long-acting β2-agonist; LAMA: long-acting muscarinic-receptor antagonist.
Vol 14 Issue 4
Table of Contents
Precision medicine in COPD: review of mepolizumab for eosinophilic COPD
