Exacerbation Reduction in Patients with Asthma Following Escalation to FF/UMEC/VI from ICS/LABA: Retrospective Cohort Study

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Abstract

Introduction: Despite fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) being available for asthma treatment in the US (United states) since 2020, real-world evidence on its clinical and economic benefits in patients with asthma is lacking. This study aimed to assess the effectiveness of FF/UMEC/VI (100/62.5/25 µg and 200/62.5/25 µg) in US patients with asthma previously on inhaled corticosteroid/long-acting β2-agonists (ICS/LABA) using administrative claims data. Methods: Retrospective, longitudinal, pre-post study utilizing data from the Komodo Health database between 09/09/2019 and 12/31/2023. Eligible adults with asthma had been treated with ICS/LABA prior to FF/UMEC/VI initiation (index date: first FF/UMEC/VI prescription). Rates of moderate–severe exacerbations, asthma-related healthcare resource utilization, oral corticosteroid (OCS) and short-acting β2-agonist (SABA) use, and asthma-related medical costs were evaluated pre- (12 months pre-index) and post-FF/UMEC/VI initiation (12 months post-index). Statistical analyses involved rate ratios (RRs) from a Poisson regression model, odds ratios (ORs) from logistic regression models, and mean differences from linear regression models. Exploratory analyses stratified these results by pre-index ICS/LABA combination and FF/UMEC/VI index dose. Results: In total, 17,959 patients were included. Following FF/UMEC/VI initiation, odds of having ≥ 1 exacerbation were reduced by 52% (OR [95% confidence interval (CI)] 0.48 [0.46, 0.50]; P < 0.001), rate of moderate–severe exacerbations reduced by 38% (RR [95% CI] 0.62 [0.61, 0.64]; P < 0.001) and asthma-related hospitalizations by 25% (RR [95% CI] 0.75 [0.68, 0.83]; P < 0.001). Odds of ≥ 1 OCS dispensing were reduced by 36% (OR [95% CI] 0.64 [0.62, 0.67]; P < 0.001) and ≥ 1 SABA canister use by 54% (OR [95% CI]: 0.46 [0.44, 0.48]; P < 0.001) post initiation; mean annualized asthma-related medical costs were reduced by $1115 ([95% CI] [$ −1771, $ −459]; P < 0.001). Both FF/UMEC/VI dosage groups had similar results. Conclusions: In patients who remain uncontrolled despite ICS/LABA treatment, escalating to FF/UMEC/VI is associated with reductions in asthma exacerbations, asthma-related hospitalizations, OCS use, SABA use, and asthma-related medical costs.

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Baptist, A. P., Paczkowski, R., Germain, G., Klimek, J., Laliberté, F., Schell, R. C., … Noorduyn, S. G. (2025). Exacerbation Reduction in Patients with Asthma Following Escalation to FF/UMEC/VI from ICS/LABA: Retrospective Cohort Study. Pulmonary Therapy, 11(4), 725–740. https://doi.org/10.1007/s41030-025-00327-w

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