Rationale: Results from clinical trials in patients with severe eosinophilic asthma have demonstrated that mepolizumab is well tolerated and is associated with improved asthma control as evidenced by reductions in both exacerbations and maintenance oral corticosteroid use, and improvements in lung function, asthma control, and quality of life. However, real-world data are lacking on the impact of mepolizumab treatment. Objective: To assess the effect of mepolizumab treatment on the rate of asthma exacerbations and asthma exacerbation-related costs in a real-world setting.Methods: This retrospective cohort study (GSK ID: 209017; HO-18-19168) analyzed data from patients with severe asthma ≥12 years of age at mepolizumab treatment initiation (index date) with ≥12 months pre-(baseline) and post-index (follow-up) data from a commercial claims database (patients were identified from November 1, 2015 to March 31, 2017). Asthma exacerbations (primary objective) and asthma exacerbationrelated costs (secondary objective) in the baseline and follow-up periods were compared. Other analyses included the number of mepolizumab administrations and the use of concomitant asthma medications. Results: Data were analyzed from 346 patients. Mepolizumab significantly reduced the proportion of patients with any exacerbation and exacerbations requiring hospitalization, compared with baseline. Significant reductions in the rate of all exacerbations of 38.4% (from 2.68 to 1.65 events/patient/year; P<0.001) and of exacerbations requiring hospitalization of 72.7% (from 0.11 to 0.03 events/patient/year; P=0.004) were observed, compared with baseline. Mean total asthma exacerbation-related costs (excluding mepolizumab acquisition and administrative costs) per person were significantly lower during follow-up compared with baseline (P<0.05) and the use of asthma medications, including oral and inhaled corticosteroids, was also lower. Conclusion: This study confirms the clinical benefit observed in previous mepolizumab clinical trials and demonstrates that mepolizumab is effective in a real-world setting. Plain-Language SummaryWhy was the study done? Mepolizumab is a biologic therapy given as an add-on treatment to patients with severe asthma whose symptoms are not controlled with controller therapy. Mepolizumab has been shown to reduce the rate of asthma exacerbations and use of oral corticosteroids in clinical trials, but there is currently a lack of data on the impact of mepolizumab treatment initiation in a real-world setting.
Blood eosinophil counts decreased following initiation of SCS therapy and had not returned to index levels several weeks after SCS discontinuation. The time frame of SCS discontinuation is an important consideration when identifying patients with eosinophilic asthma.
PurposeBased on blood and sputum samples, up to 40% of patients with COPD have eosinophilic inflammation; however, there is little epidemiology data characterizing the health care burden within this sub-population. Given that COPD-attributable medical costs in the USA are predicted to approach $50 billion by 2020, we analyzed the effect of blood eosinophil counts and exacerbations on health care resource utilization and costs.Patients and methodsThis cross-sectional study used electronic medical records and insurance claims data from the Reliant Medical Group (January 2011–December 2015). Eligible patients were ≥40 years of age, continuously enrolled during the year of interest (2012, 2013, 2014, or 2015), had ≥1 COPD-related code in the preceding year, and documented maintenance therapy use. Patients with ≥1 blood eosinophil count recorded were stratified into 2 cohorts: <150 cells/µL and ≥150 cells/µL. Endpoints included demographics, clinical characteristics, health care resource utilization, and costs. The impact of blood eosinophil count and exacerbation patterns on health care resource utilization and costs was assessed with multivariate analyses.ResultsOn average, 2,832 eligible patients were enrolled annually, of whom ~28% had ≥1 eosinophil count recorded during the year. The ≥150 cells/µL cohort had numerically higher all-cause and COPD-related health care resource utilization and cost each year compared with the <150 cells/µL cohort, but varied by service and year. Among patients with exacerbations, the ≥150 cells/µL cohort exhibited significantly higher COPD-related costs compared with the <150 cells/µL cohort.ConclusionBlood eosinophil counts may be a useful biomarker for burden of disease in a subgroup of patients with COPD.
Background: Patients with severe asthma can present with overlapping eosinophilic and allergic phenotypes, which makes it challenging when deciding which biologic therapy is most appropriate to reduce exacerbations and help achieve asthma control. Objective: This post hoc meta-analysis evaluated the efficacy of the licensed dose of mepolizumab (100 mg administered subcutaneously [SC]) versus placebo in patients with severe eosinophilic asthma (SEA), according to omalizumab eligibility and associated allergic characteristics. Methods: Data from two Phase 3 studies (MENSA [MEA115588/NCT01691521]; MUSCA [200862/ NCT02281318]) were analyzed. Patients ≥12 years of age with SEA who experienced ≥2 exacerbations in the previous year received placebo, mepolizumab 100 mg SC or 75 mg intravenously, plus standard of care (highdose inhaled corticosteroids and other controllers), every 4 weeks. Data from patients who received ≥1 dose placebo or mepolizumab 100 mg SC were used for this analysis. The primary endpoint was the rate of clinically significant exacerbations; other outcomes included forced expiratory volume in 1 s (FEV 1 ), Asthma Control Questionnaire (ACQ-5) score and quality of life measured using St George's Respiratory Questionnaire (SGRQ). Results: Rate reductions in clinically significant exacerbations with mepolizumab versus placebo were similar in omalizumab eligible and ineligible patients (57% vs 55%). FEV 1 , ACQ-5 and SGRQ scores improved with mepolizumab versus placebo regardless of omalizumab eligibility, Immunoglobulin E levels, or atopic status. Conclusion: This analysis indicated that mepolizumab 100 mg SC has clinical benefit in patients with blood eosinophil counts ≥150 cells/μL (or history of ≥300 cells/μL), regardless of allergic characteristics or omalizumab eligibility.
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