Exacerbations and Real-World Outcomes After Single-Inhaler Triple Therapy of Budesonide/Glycopyrrolate/Formoterol Fumarate, Among Patients with COPD: Results from the EROS (US) Study

Abstract

Purpose

Triple therapy to prevent exacerbations from chronic obstructive pulmonary disease (COPD) is associated with improved health compared to single and dual-agent therapy in some populations. This study assessed the benefits of prompt administration of budesonide/glycopyrrolate/formoterol fumarate (BGF) following a COPD exacerbation.

Patients and methods

EROS was a retrospective analysis of people with COPD using the MORE² Registry^®. Inclusion required ≥1 severe, ≥2 moderate, or ≥1 moderate exacerbation while on other maintenance treatment. Within 12 months following the index exacerbation, ≥1 pharmacy claim for BGF was required. Primary outcomes were the rate of COPD exacerbations and healthcare costs for those that received BGF promptly (within 30 days of index exacerbation) versus delayed (31–180 days) and very delayed (181–365 days). The effect of each 30-day delay in initiation of BGF was estimated using a multivariable negative binomial regression model.

Results

2409 patients were identified: 434 prompt, 1187 delayed, and 788 very delayed. The rate (95% CI) of total exacerbations post-index increased as time to BGF initiation increased: prompt 1.52 (1.39–1.66); delayed 2.00 (1.92–2.09); and very delayed 2.30 (2.20–2.40). Adjusting for patient characteristics, each 30-day delay in receiving BGF was associated with a 5% increase in the average number of subsequent exacerbations (rate ratio, 95% CI: 1.05, 1.01–1.08; p<0.05). Prompt initiation of BGF was also associated with lower post-index annualized COPD-related costs ($5002 for prompt vs $7639 and $8724 for the delayed and very delayed groups, respectively).

Conclusion

Following a COPD exacerbation, promptly initiating BGF was associated with a reduction in subsequent exacerbations and reduced healthcare utilization and costs.

Keywords:

• COPD
• triple therapy
• exacerbations
• delayed therapy
• budesonide/glycopyrrolate/formoterol fumarate

Abbreviations

ANOVA, analysis of variance; BGF, Budesonide/glycopyrrolate/formoterol; CI, confidence interval; COPD, Chronic obstructive pulmonary disease; ECI, Elixhauser Comorbidity Index; ED, emergency department; FDA, Food and Drug Administration; GOLD, Global Initiative for Chronic Obstructive Lung Disease; HCRU, healthcare resource utilization; ICS, inhaled corticosteroid; LABA, long-acting β2-agonist; LAMA, long-acting muscarinic antagonist; OCS, oral corticosteroids; PPPY, per-patient-per-year; SD, standard deviation; UC, urgent care.

Ethics Approval and Informed Consent

As this was an analysis of de-identified claims data compliant with guidance related to the Health Insurance Portability and Accountability Act (HIPAA) privacy rule, institutional review board (IRB) approval was not required. Per Title 45 of CFR, Part 46, the administrative claims data analysis of our study was exempt from the IRB review as it was a retrospective analysis of existing data (hence no patient intervention or interaction), and no patient-identifiable information was included in the claims dataset.

Acknowledgments

Interim partial results for this paper were presented at American Thoracic Society conference 2023 and have been accepted for presentation at the American College of Chest Physicians conference 2023. The poster abstract was published in the American Journal of Respiratory and Critical Care Medicine, https://doi.org/10.1164/ajrccm-conference.2023.207.1_MeetingAbstracts.A6019.

Author Contributions

All authors had access to the data, had a role in writing this manuscript, including critically reviewing the manuscript, and made significant contributions to this work. All authors agreed on the journal submission choice, have agreed on all revisions, gave final approval for the version to be published, and agreed to be accountable for all aspects of the work.

Disclosure

SS, SP, DE, NF, and MP are employees of AstraZeneca and hold AstraZeneca stock. JT, JS, BL, and BA are employees of Inovalon, who received funding from AstraZeneca to conduct this study. DRT, EP, and CS are paid consultants of AstraZeneca. DRT reports personal fees from Stage Analytics, eMax Health, Horizon Pharmaceuticals, Monument Analytics; grants from Takeda Pharmaceuticals, outside the submitted work. CS reports personal fees from AlphaNet, Adverum, CSL Behring, Morair, UpToDate, GlaxoSmithKline; grants from Arrowhead, OCI, Pandorum, Pulmanage, Takeda, Vertex, NuVaira, CSA Medical, Grifols, Pulmonx, and AstraZeneca, outside the submitted work. The authors report no other conflicts of interest in this work.

Additional information

Funding

This study was sponsored by AstraZeneca.