Real-World Study of Single-Inhaler Triple Therapy with Fluticasone Furoate/Umeclidinium/Vilanterol on Asthma Control in the US

Abstract

Purpose

Real-world asthma control data among patients initiating fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) are limited. This study assessed rescue medication use and asthma-related exacerbations in patients with asthma before and after initiating single-inhaler FF/UMEC/VI using administrative claims data.

Patients and Methods

This retrospective, pre-post cohort study analyzed data from the IQVIA PharMetrics Plus database (September 18, 2016‒March 31, 2020). Patients aged ≥18 years that had ≥1 dispensing of single-inhaler FF/UMEC/VI 100/62.5/25 mcg (first dispensing = index date), ≥12 months of continuous health insurance enrollment prior to (pre-treatment) and following (post-treatment) FF/UMEC/VI initiation and ≥1 diagnosis of asthma during the pre-treatment period or on the index date were included. The primary endpoint was the number of oral corticosteroid (OCS) dispensings per patient per year during pre- and post-treatment periods. Secondary endpoints included asthma-related exacerbation rates and short-acting β₂-agonist (SABA) use. Comparisons between pre- and post-treatment periods were made using risk and rate ratios.

Results

Overall, 890 patients with asthma initiating treatment with FF/UMEC/VI were included. The most recently dispensed controller medications prior to FF/UMEC/VI initiation were inhaled corticosteroids/long-acting β₂-agonists (33.5%) and leukotriene modifiers (33.0%). Patients had a 29% reduction in the number of OCS dispensings (rate ratio [95% confidence interval (CI)]: 0.71 [0.65, 0.77], P < 0.001) during post-treatment versus pre-treatment, with a 23% reduction in the proportion of patients with ≥1 OCS dispensing post-treatment (risk ratio [95% CI]: 0.77 [0.73, 0.82], P < 0.001). Significant reductions in rates (rate ratio [95% CI]) of asthma-related exacerbations (0.59 [0.52, 0.67], P < 0.001) and SABA use (0.80 [0.74, 0.86], P < 0.001) were also observed.

Conclusion

In this real-world study, patients with asthma had significantly lower OCS use, asthma-related exacerbations, and SABA use following treatment initiation with FF/UMEC/VI compared with their pre-treatment period. These results suggest better asthma control following initiation of FF/UMEC/VI in a routine clinical practice setting.

Keywords:

• oral corticosteroids
• rescue medication use
• asthma control
• FF/UMEC/VI
• asthma exacerbations

Data Sharing Statement

The data that support the findings of this study are available from IQVIA and are not publicly available. Restrictions apply to the availability of these data, which were used under license for the current study.

Acknowledgments

This study was funded by GSK (GSK study 214181). ELLIPTA is owned by or licensed to the GSK Group of Companies. IQVIA PharMetrics Plus is a trademark of IQVIA Inc. 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 Christopher Heath, PhD, and Suzanna Lim, PhD, of Fishawack Indicia Ltd, UK, part of Avalere Health, and was funded by GSK.

Abstracts based on this study were previously presented as poster presentations at the CHEST 2022 Annual Meeting, Nashville, Tennessee, October 18, 2022, poster No. 2068; and the CHEST 2023 Annual Meeting, Honolulu, Hawaiʻi, October 10, 2023, poster No. 4608.

Author Contributions

All authors made a significant contribution to the work reported, whether that is 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 article; 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

KD, SGN, and RP are employees of GSK and hold stock and shares at GSK. MB is a former employee of GSK and holds stocks and shares at GSK. GG, FL, MM, and MSD are employees of Analysis Group, a consulting company that received research funds from GSK to conduct this study but did not receive payment for manuscript development. MSD also reports that Analysis Group has received grants from AbbVie, Apellis, AstraZeneca, Ayala Pharmaceuticals, Bayer, Blueprint Medicines, GSK, Humacyte, Janssen, Merck, Novartis, Pfizer, Sanofi, and Takeda, outside the submitted work. RB is a staff Pulmonary Physician at the National Jewish Health and is on speaker bureaus and advisory boards for GSK, AstraZeneca, Sanofi, Merck, and Regeneron. The authors report no other conflicts of interest in this work.

Additional information

Funding

This study was funded by GSK (214181).