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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Lifetime Benefits for Budesonide/Glycopyrrolate/Formoterol Fumarate versus Long-Acting Muscarinic Antagonist/Long-Acting β2-Agonist and Inhaled Corticosteroid/Long-Acting β2-Agonist Therapies in Moderate-to-Very Severe Chronic Obstructive Pulmonary Disease
Session Title
TP40 - TP040 COPD CLINICAL TRIALS AND THERAPIES
Abstract
A2248 - Lifetime Benefits for Budesonide/Glycopyrrolate/Formoterol Fumarate versus Long-Acting Muscarinic Antagonist/Long-Acting β2-Agonist and Inhaled Corticosteroid/Long-Acting β2-Agonist Therapies in Moderate-to-Very Severe Chronic Obstructive Pulmonary Disease
Author Block: E. De Nigris1, C. Treharne2, N. Brighton2, U. Holmgren3, A. Walker4, J. Haughney5; 1AstraZeneca, Cambridge, United Kingdom, 2Parexel International, London, United Kingdom, 3AstraZeneca, Gothenburg, Sweden, 4Salus Alba, Glasgow, United Kingdom, 5Clinical Research Facility, Queen Elizabeth University Hospital, Glasgow, United Kingdom.
Rationale: Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality worldwide, causing substantial economic and social burden, mostly attributed to exacerbations. The ETHOS trial (NCT02465567; primary endpoint: annual rate of moderate or severe COPD exacerbations) demonstrated the efficacy of triple therapy with budesonide/glycopyrrolate/formoterol fumarate (BGF) versus long-acting muscarinic antagonist/long-acting β2-agonist (LAMA/LABA) and inhaled corticosteroid (ICS)/LABA dual therapies over 52 weeks.1 To inform reimbursement decisions, this analysis utilized a modeling approach to extrapolate ETHOS data to estimate the lifetime clinical effectiveness of BGF 320/18/9.6 µg versus LAMA/LABA and ICS/LABA therapies in patients with moderate-to-very severe COPD. Methods: Using data from the overall ETHOS population and published literature, a semi-Markov model was developed to simulate the natural history of patients recruited in ETHOS. Health states were defined based on airflow limitation (forced expiratory volume in 1 second % predicted; moderate/severe/very severe) and exacerbation history (no exacerbation/post-moderate/post-severe). Probabilities for transitions between COPD severity states and exacerbation rates were estimated from ETHOS data. Mortality rates for the first year in each treatment arm came from ETHOS data and subsequent years were modeled dependent on airflow limitation based on the death standardized mortality ratios versus the general population according to COPD severity (30 year time horizon). A sensitivity analysis was conducted, extrapolating mortality rates in each treatment arm over 5 years, with subsequent years modeled dependent on airflow limitation (30 year time horizon). Outcomes included life-years (LYs), quality-adjusted LYs (QALYs), and the number of exacerbations per patient. Results: In the mortality analysis based on the first year of treatment, total LYs and QALYs for a patient treated with BGF 320 (11.11 and 8.13) indicated a lifetime benefit compared with LAMA/LABA (10.74 and 7.82) and ICS/LABA (10.31 and 7.42). Similarly, both moderate and severe lifetime exacerbation events were lowest for BGF (9.35 and 1.68) compared with LAMA/LABA (11.49 and 1.99) and ICS/LABA (10.35 and 2.53). The mortality analysis based on 5-year treatment data extrapolations (Table) showed that incremental benefits in QALYs and LYs with BGF treatment were approximately two-fold higher than LAMA/LABA and slightly improved versus ICS/LABA in comparison to the base case analysis. Conclusion: In patients with moderate-to-very severe COPD, modeling using ETHOS data demonstrated better outcomes with BGF 320 triple therapy versus dual therapies over a lifetime, particularly in reducing exacerbations and risk of mortality. 1. Rabe et al. N Engl J Med 2020; 383:35-48
Author Block: E. De Nigris1, C. Treharne2, N. Brighton2, U. Holmgren3, A. Walker4, J. Haughney5; 1AstraZeneca, Cambridge, United Kingdom, 2Parexel International, London, United Kingdom, 3AstraZeneca, Gothenburg, Sweden, 4Salus Alba, Glasgow, United Kingdom, 5Clinical Research Facility, Queen Elizabeth University Hospital, Glasgow, United Kingdom.
Rationale: Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality worldwide, causing substantial economic and social burden, mostly attributed to exacerbations. The ETHOS trial (NCT02465567; primary endpoint: annual rate of moderate or severe COPD exacerbations) demonstrated the efficacy of triple therapy with budesonide/glycopyrrolate/formoterol fumarate (BGF) versus long-acting muscarinic antagonist/long-acting β2-agonist (LAMA/LABA) and inhaled corticosteroid (ICS)/LABA dual therapies over 52 weeks.1 To inform reimbursement decisions, this analysis utilized a modeling approach to extrapolate ETHOS data to estimate the lifetime clinical effectiveness of BGF 320/18/9.6 µg versus LAMA/LABA and ICS/LABA therapies in patients with moderate-to-very severe COPD. Methods: Using data from the overall ETHOS population and published literature, a semi-Markov model was developed to simulate the natural history of patients recruited in ETHOS. Health states were defined based on airflow limitation (forced expiratory volume in 1 second % predicted; moderate/severe/very severe) and exacerbation history (no exacerbation/post-moderate/post-severe). Probabilities for transitions between COPD severity states and exacerbation rates were estimated from ETHOS data. Mortality rates for the first year in each treatment arm came from ETHOS data and subsequent years were modeled dependent on airflow limitation based on the death standardized mortality ratios versus the general population according to COPD severity (30 year time horizon). A sensitivity analysis was conducted, extrapolating mortality rates in each treatment arm over 5 years, with subsequent years modeled dependent on airflow limitation (30 year time horizon). Outcomes included life-years (LYs), quality-adjusted LYs (QALYs), and the number of exacerbations per patient. Results: In the mortality analysis based on the first year of treatment, total LYs and QALYs for a patient treated with BGF 320 (11.11 and 8.13) indicated a lifetime benefit compared with LAMA/LABA (10.74 and 7.82) and ICS/LABA (10.31 and 7.42). Similarly, both moderate and severe lifetime exacerbation events were lowest for BGF (9.35 and 1.68) compared with LAMA/LABA (11.49 and 1.99) and ICS/LABA (10.35 and 2.53). The mortality analysis based on 5-year treatment data extrapolations (Table) showed that incremental benefits in QALYs and LYs with BGF treatment were approximately two-fold higher than LAMA/LABA and slightly improved versus ICS/LABA in comparison to the base case analysis. Conclusion: In patients with moderate-to-very severe COPD, modeling using ETHOS data demonstrated better outcomes with BGF 320 triple therapy versus dual therapies over a lifetime, particularly in reducing exacerbations and risk of mortality. 1. Rabe et al. N Engl J Med 2020; 383:35-48
