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Browse ATS 2021 Abstracts

HomeProgram ▶ Browse ATS 2021 Abstracts
 

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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Relationship Between Prior Inhaled Corticosteroid Use and Benefits of Budesonide/Glycopyrrolate/Formoterol Fumarate on Exacerbation Risk in Patients with Chronic Obstructive Pulmonary Disease: Analysis from the ETHOS Study

Session Title
TP40 - TP040 COPD CLINICAL TRIALS AND THERAPIES
Abstract
A2245 - Relationship Between Prior Inhaled Corticosteroid Use and Benefits of Budesonide/Glycopyrrolate/Formoterol Fumarate on Exacerbation Risk in Patients with Chronic Obstructive Pulmonary Disease: Analysis from the ETHOS Study
Author Block: D. Singh1, K. F. Rabe2, F. J. Martinez3, M. Jenkins4, M. Patel4, P. Dorinsky5; 1Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Trust, Manchester, United Kingdom, 2LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, Member of the German Center for Lung Research (DZL), Grosshansdorf, Germany, 3Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York, NY, United States, 4AstraZeneca, Cambridge, United Kingdom, 5AstraZeneca, Durham, NC, United States.
Rationale: In the Phase III ETHOS study (NCT02465567), the inhaled corticosteroid (ICS)/long‑acting muscarinic antagonist/long-acting β2‑agonist triple fixed-dose combination budesonide/glycopyrrolate/formoterol fumarate (BGF) significantly reduced exacerbations versus dual therapies at two ICS dose levels in patients with moderate-to-very severe chronic obstructive pulmonary disease (COPD) who had ≥1 moderate/severe exacerbation in the prior year. This post-hoc analysis of moderate/severe exacerbation events by prior ICS was performed to determine whether the treatment benefit for BGF versus glycopyrrolate/formoterol fumarate (GFF) was driven by ICS withdrawal in patients who had received ICS prior to randomization to GFF. Methods: ETHOS was a 52-week randomized, double-blind, multi-center, parallel-group study. Patients received BGF 320/18/9.6µg, BGF 160/18/9.6μg, GFF 18/9.6µg, or budesonide/formoterol fumarate 320/9.6µg twice-daily via a single Aerosphere inhaler. The rate of moderate/severe exacerbations and time to first moderate/severe or severe exacerbation by prior ICS use were assessed over 52 weeks in patients receiving BGF versus GFF; analyses excluding the first 30/60/90 days of treatment evaluated the impact of acute ICS withdrawal. Results: The modified intent-to-treat population comprised 8509 patients (prior ICS use, N=6810 [80%]; no prior ICS use, N=1699 [20%]). Moderate/severe exacerbation rates for BGF 320 versus GFF were reduced by 24% in patients with prior ICS use and 23% in patients without prior ICS use (Table). Analysis based on time to first moderate/severe exacerbation demonstrated a 12% reduction in exacerbation risk with BGF 320 versus GFF in patients with prior ICS use and an 11% reduction in patients without prior ICS use. For time to first severe exacerbation, a risk reduction was demonstrated with BGF 320 versus GFF of 13% in patients with prior ICS use and 20% in patients without prior ICS use. Regardless of prior ICS use, the rate of moderate/severe exacerbations was reduced with BGF 320 versus GFF when the first 30/60/90 days of treatment were excluded from analyses (13%-22%). Similar trends were observed for BGF 160 versus GFF, with similar rate reductions, regardless of prior ICS use. Conclusion: In this post-hoc analysis, the benefits of BGF versus GFF on reducing the rate of moderate/severe exacerbations were consistent regardless of prior ICS use and when the first 30/60/90 days of treatment were excluded. These findings support the conclusion that observed benefits were not driven by acute ICS withdrawal in patients who had received ICS prior to randomization to GFF.