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Browse ATS 2021 Abstracts

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ATS 2021 will feature presentations of original research from accepted abstracts. Mini Symposia and Thematic Poster Sessions are abstract based sessions.

Please use the form below to browse scientific abstracts and case reports accepted for ATS 2021. Abstracts presented at the ATS 2021 will be published in the Online Abstract Issue of the American Journal of Respiratory and Critical Care Medicine, Volume 203, May 3, 2021.

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Prediction of 5 Year Severe Exacerbation and Mortality Risk by Baseline Exacerbation Status in the US- Application of the ETHOS Trial to a Real-World Analysis of COPD Patients

Session Title
C8 - C008 INNOVATIONS AND UPDATES IN THE STUDY AND MANAGEMENT OF COPD
Abstract
A1133 - Prediction of 5 Year Severe Exacerbation and Mortality Risk by Baseline Exacerbation Status in the US- Application of the ETHOS Trial to a Real-World Analysis of COPD Patients
Author Block: M. Pollack1, E. De Nigris2, S. Sethi3, C. Moretz4, N. Feigler5; 1Respiratory & Immunology; Payer Evidence, AstraZeneca, Wilmington, DE, United States, 2AstraZeneca, Cambridge, United Kingdom, 3Medicine, University at Buffalo, Buffalo, NY, United States, 4Health Economics & Advanced Analytics, Avalere Health, LLC, Washington, DC, United States, 5US Medical- Respiratory & Immunology, AstraZeneca, Wilmington, DE, United States.
Rationale: As of 2018, COPD was the 4th-leading cause of mortality in the US and costs more than $36 billion per year. A majority of morbidity, mortality and healthcare costs are associated with acute exacerbations; with baseline exacerbation history being one of the strongest determinants of future exacerbations. This modeling activity seeks to estimate the risk for mortality and severe exacerbation events over time, using real-world data from a large analysis of COPD patients (HERA-II) and applying corresponding death rates from the ETHOS trial. Methods: HERA-II is a real-world observational study of exacerbations and healthcare utilization in 1.55 million COPD patients using Medicare FFS claims and the multi-payer MORE2Registry® consisting of Commercial, Medicaid and Medicare Advantage plans. The ETHOS trial (NCT02497001), whose primary endpoint was the annual rate of moderate or severe COPD exacerbations, demonstrated the efficacy and safety of fixed dose BUD/GLY/FORM MDI versus GLY/FORM MDI and BUD/FORM MDI dual therapies over 52 weeks. Using real-world data from HERA-II we have estimated exacerbation transition matrices for year-1 to 2 and year-2 to 3 for four progressive categories: [A] no exacerbation, [B] 1 moderate exacerbation, [C] ≥2 moderate exacerbations, but no severe exacerbation and [D] ≥1 severe exacerbation. Transition to death matrices estimated with multi-state modelling with ETHOS data, were also created. These matrices were used to model and extrapolate the cumulative incidence of death and a composite endpoint of severe exacerbation and/or death over 5 years. Results: For patient categories A through D the 5-year mortality risk was 9.9%, 15.2%, 18.1%, and 42.6% (Fig.1-A). The risk of the composite endpoint for these categories was projected to be 29.3%, 49.0%, 57.3%, 77.0% at 5 years, respectively (Fig.1-B). Compared to category A, the unadjusted mean relative risks of death for categories B thorough D were 1.53, 1.82 and 4.30; unadjusted mean relative risks for the composite endpoint were 1.68, 1.96 and 2.63, respectively. For a Medicare plan of 1,000,000 members with 128,000 COPD patients, over 5 years a total of 17,979 deaths and 26,017 additional patients experiencing ≥1 severe exacerbations were projected. Conclusion: Our models suggest that risk of mortality and morbidity in COPD patients is projected to increase among those with even one moderate exacerbation; more so for patients with ≥1 severe exacerbation. Targeting factors associated with exacerbations, such as comorbidities and suboptimal maintenance treatment, may improve patients survival and reduce burden of these events on society and health plans.