Changes in Oral Corticosteroid Utilization in Patients with COPD Following Initiation of FF/UMEC/VI

Abstract

Purpose

Oral corticosteroids (OCS) play a role in the treatment of acute chronic obstructive pulmonary disease (COPD) exacerbations; however, chronic use is not recommended due to the high rate of systemic complications, development of comorbidities, and increased mortality. Data assessing the real-world impact of fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) on OCS utilization rates are limited. This study assessed the impact of FF/UMEC/VI on OCS use among patients with COPD previously treated with OCS.

Patients and Methods

A retrospective database study of patients with COPD aged ≥40 years who initiated FF/UMEC/VI from 1 November 2017 to 31 December 2018, identified through the MarketScan^® Commercial and Medicare Supplemental databases. Patients were required to have ≥1 dispensing of an OCS prior to initiation of FF/UMEC/VI (index) and were followed up for 12 months post-index. OCS utilization patterns, potential OCS-related adverse events, healthcare resource utilization (HCRU), and costs were compared between the 12-month pre- and post-index periods.

Results

A total of 2013 patients were identified (mean age 63.5 years, 55.7% female). The proportion of patients with ≥1 OCS claim decreased by 32.2% between the pre- and post-index period (67.8% vs 100%; p < 0.001). Comparing the post-index period to the pre-index period, mean number of OCS pharmacy claims per patient decreased from 3.3 to 2.5 (p < 0.001) and mean daily dose was reduced from 3.1 to 2.6 mg/day (p = 0.004); 30.0% of patients reduced their daily dose by 90–100%. Reductions were also seen in COPD-related HCRU. The proportion of patients with an inpatient admission for COPD decreased from 11.4% to 7.1% (p < 0.001), emergency room visits decreased from 23.1% to 17.4% (p < 0.001), and office visits from 97.5% to 90.1% (p < 0.001). Similar results were seen for all-cause HCRU.

Conclusion

Among patients with COPD with prior OCS use, FF/UMEC/VI initiation resulted in significant reductions in OCS utilization, COPD-related HCRU (including hospitalization), and all-cause HCRU.

Plain Language Summary

Oral corticosteroids (OCS) are drugs that are often used in the short term to treat chronic obstructive pulmonary disease (COPD) exacerbations. Long-term use of OCS is not recommended as this can increase the risk of pneumonia and death. Fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) is a maintenance treatment for COPD, which combines three drugs into one inhaler. In this study, we investigated OCS use before and after starting FF/UMEC/VI. We found that there were 32.2% less patients with an OCS claim in the year after starting FF/UMEC/VI compared with the year before. In addition, 30.0% of patients reduced their daily OCS dose by 90–100%. We also looked at how often patients were using healthcare services because of their COPD after starting FF/UMEC/VI, and how much this cost. We found that there were fewer inpatient stays, emergency room visits, and doctor’s office visits due to COPD in the year after starting FF/UMEC/VI treatment compared with the year before. Overall, these results show that patients who use OCS every day may be able to reduce their dose after starting FF/UMEC/VI treatment, which may avoid some of the potential side effects of OCS.

Keywords:

• COPD
• FF/UMEC/VI
• oral corticosteroids

Abbreviations

COPD, chronic obstructive pulmonary disease; ER, emergency room; FF/UMEC/VI, fluticasone furoate/umeclidinium/vilanterol; HCRU, healthcare resource utilization; OCS, oral corticosteroids; PDC, proportion of days covered; SD, standard deviation; SITT, single-inhaler triple therapy.

Data Sharing Statement

The data that support the findings of this study are available from Merative (https://www.merative.com/). Restrictions apply to the availability of these data, which were used under license for this study.

Ethics Approval and Informed Consent

All database records are statistically de-identified and certified to be fully compliant with US patient confidentiality requirements set forth in the Health Insurance Portability and Accountability Act of 1996. Because this study used only de-identified patient records and did not involve the collection, use, or transmittal of individually identifiable data, this study did not require institutional review board approval.

Acknowledgments

Editorial support (in the form of writing assistance, including preparation of the draft manuscript under the direction and guidance of the authors, collating and incorporating authors’ comments for each draft, assembling tables and figures, grammatical editing, and referencing) was provided by Kathryn Wardle of Apollo, OPEN Health Communications, and was funded by GSK.

These data have been previously presented in abstract/presentation form at the American College of Chest Physicians – CHEST Annual Meeting, virtual event, 17–20 October, 2021: Bogart M, Bangalore M, McMorrow D, Packnett E. Changes in oral corticosteroids utilization in patients with COPD following initiation of FF/UMEC/VI. CHEST. 2021;160(4):A1826. doi: 10.1016/j.chest.2021.07.1641

Author Contributions

All authors made a significant contribution to the work reported, whether that was in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising, or critically reviewing the manuscript; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.

Disclosure

MBo, CBA, and MBa were employees of, and/or shareholders in, GSK at the time of study. DM and ERP are employees of Merative (IBM Watson Health at the time of study), which received research funds from GSK to conduct this study, but not for manuscript development. KD is an employee of, and/or shareholder in, GSK. The authors report no other conflicts of interest in this work.

Additional information

Funding

This study was funded by GSK (study number 214319). The sponsor was involved in study conception and design, data interpretation, and the decision to submit the article for publication. The sponsor was also given the opportunity to review the manuscript for medical and scientific accuracy as well as intellectual property considerations.