B40-13 Improved Clinical Outcomes and Achievability of Clinical Remission After Initiation of Fluticasone Furoate/Umeclidinium/Vilanterol in Patients With Asthma in the United States

Rationale

Fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) has been available in the United States (US) to treat adult asthma since 2020, based on results from the Phase 3 CAPTAIN trial. Previous real-world studies have demonstrated that initiating FF/UMEC/VI reduces exacerbations in patients previously treated with inhaled corticosteroid (ICS)/long-acting β2-agonist therapy. These prior findings are limited to database analyses, which often lack information on laboratory tests and longer-term outcomes. This real-world study assessed treatment response, including achievability of a composite endpoint for clinical remission (CR), among US patients with asthma 1 year after initiating FF/UMEC/VI.

Methods

This was a retrospective, pre/post, physician chart review study in the US. Eligible patients were adults (≥18 years) with asthma who initiated FF/UMEC/VI (100/62.5/25mcg, 200/62.5/25mcg) between 9/9/2020 and 8/31/2023 (index date) and remained on therapy for ≥12-months post-initiation with medical records available for ≥12-months pre-initiation. Treatment response was assessed as changes in exacerbation frequency, lung function (LF), medication use, clinical characteristics, and health-related quality of life (HRQoL) pre- versus post-initiation. CR was assessed as a composite endpoint 12-months post-initiation: no oral corticosteroid use, no exacerbations, well-controlled asthma (Asthma Control Test score ≥20 or Asthma Control Questionnaire-6 score <1.5) and either optimized LF (≥100 mL improvement in forced expiratory volume in 1 second [FEV1] from baseline or FEV1 ≥80% predicted) or stabilized LF (no worsening in FEV1 or FEV1% predicted from baseline).

Results

A total of 310 patients were abstracted by 110 physicians (46.4% pulmonologists, 30.0% allergists/immunologists, 23.6% general practitioners). Mean patient age was 40.5 years; 57.1% were female; 5.2%, 67.7%, and 27.1% had mild, moderate, and severe asthma, respectively. Post-initiation, there were significant reductions in asthma exacerbations (rate ratio [95% confidence interval]: 0.44 [0.38-0.51], p < 0.001) and significant improvements in LF (odds ratio [95% confidence interval]: 3.68 [2.79-4.86], p < 0.001). There were also numerical reductions in short-acting β2-agonist use, blood eosinophil counts and fractional exhaled nitric oxide levels, and clinically meaningful improvements in HRQoL, including change in AQLQ exceeding the minimum clinically important difference, post- versus pre-initiation (Table). Overall, 33.9% (LF optimization) and 35.5% (LF stabilization) of patients achieved CR 12-months post-initiation.

Conclusions

In patients with asthma who initiated FF/UMEC/VI, over a third achieved CR, with notable improvements in exacerbations and LF 12-months post-initiation. These findings confirm and extend prior database studies demonstrating exacerbation reduction with FF/UMEC/VI, and provide real-world evidence showing the clinical benefits of initiating FF/UMEC/VI on LF and CR in a broad asthma population in the US.

This abstract is funded by: GSK (219804)