ATS 2024 Data Support Triple Therapy FF/UMEC/VI as Preferred Option for COPD

Data show that starting furoate/umeclidinium/vilanterol without delay significantly reduces exacerbations and health care costs while increasing adherence and persistence for patients with chronic obstructive pulmonary disease.

Image credit: barmilini - stock.adobe.com

At the American Thoracic Society (ATS) 2024 International Conference, data from a pair of studies illuminate the crucial benefits of prompt initiation and superior adherence to the single-inhaler triple therapy (SITT) fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) in patients with chronic obstructive pulmonary disease (COPD). Findings from the poster presentations reveal that starting this therapy without delay not only significantly reduces exacerbations and health care costs but also enhances patient adherence and persistence compared with other treatment options, potentially reshaping clinical decision-making for millions suffering from COPD.^1,2

Lead author Stephen Noorduyn, MSc, global director of value evidence and outcomes at GSK, commented on the potential implications of the findings for health care policies, particularly concerning cost management in COPD treatment, in an email to The American Journal of Managed Care®.

"The American Lung Association estimates that the annual medical cost of COPD in the USA reached $24 billion in 2018. Exacerbations are the costliest events in COPD care, and prevention of these events is cost-saving for many health systems," he wrote. "This study shows that prompt initiation with FF/UMEC/VI reduces annual overall health care costs by nearly 20% per patient, mostly driven by a significant decrease in exacerbations in this cohort. This is relevant to policymakers and may inform care models, especially those concerned with reduction of COPD exacerbations and rates of readmission to hospital."

Effects of Prompt vs Delayed Start of FF/UMEC/VI Therapy in COPD Patients

Long-acting β2-agonists (LABAs), long-acting muscarinic antagonists (LAMAs), or a combination of both (LABA/LAMA) are standard therapeutic approaches for patients with minimal symptoms and low exacerbation risk. For those at higher risk of exacerbations, escalation to inhaled corticosteroid (ICS)/LABA/LAMA triple therapy is recommended. However, because there is limited evidence regarding the optimal timing for initiating triple therapy, researchers investigated the real-world impact of prompt versus delayed initiation of the single-inhaler triple therapy FF/UMEC/VI.¹

The first of the retrospective cohort studies utilized data from the IQVIA PharMetrics Plus database, focusing on commercially insured patients aged 40 years and older. Patients were included if they had their first COPD-related exacerbation after September 18, 2017, and were continuously enrolled for 12 months before and 6 months after the index date. Patients were categorized into prompt initiators (0-30 days from index to FF/UMEC/VI initiation) and delayed initiators (31-180 days). The study assessed COPD-related exacerbation rates, health care costs, and time-to-first exacerbation/hospital readmission using Poisson regression, linear regression, and Kaplan-Meier survival analysis, respectively. The researchers applied inverse probability of treatment weighting to balance baseline characteristics.

The data showed that out of 5421 patients, 2057 were prompt initiators, and 3364 were delayed initiators. After weighting, baseline characteristics were well-matched, with a mean age of 62.1 years and approximately 50% female in both cohorts. The results demonstrated prompt initiators had significantly lower rates overall (95% CI, 0.64–0.77) for COPD-related exacerbations (0.74 vs 1.06 per person-year [PPY]) compared with delayed initiators, exhibiting rate ratios (RR) of 0.70 (P < .001) for all categories, including moderate (0.59 vs 0.84 PPY; 95% CI, 0.64–0.78), and severe exacerbations (0.15 vs 0.22 PPY; 95% CI, 0.58–0.83).

Prompt initiators also demonstrated a 29% lower risk of severe exacerbations at 12 months (HR: 0.71, P <.001). Additionally, COPD-related total health care costs were significantly lower for prompt initiators ($8,483 vs $10,587PPY, P = .010). They also had a 38% lower risk of all-cause hospital readmissions and a 42% lower risk of COPD-related hospital readmissions within 90 days post-index.

Noorduyn et al, concluded that prompt initiation of FF/UMEC/VI significantly reduces exacerbations, health care costs, and hospital readmissions compared with delayed initiation, suggesting that health care providers should consider the timely initiation of FF/UMEC/VI to optimize cost-effectiveness and clinical outcomes for patients with COPD who are at risk of exacerbations.

"While we did not present data beyond 12 months, it is important to remember that COPD exacerbations are serious health events with long-term implications for patients. As such, prevention of these events is a primary goal of treatment in COPD," Noorduyn explained. "In this study, we found a significant benefit for prompt escalation to FF/UMEC/VI following a COPD exacerbation, with a clear reduction in exacerbations noted even one year later compared with those who delayed escalation."

Adherence and Persistence in COPD Treatment With FF/UMEC/VI vs BUD/GLY/FORM

The second retrospective cohort study explored the potential to improve adherence by simplifying the treatment regimen with FF/UMEC/VI, the only SITT with a once-daily dosing schedule. Noorduyn and his team aimed to compare adherence and persistence between FF/UMEC/VI and another triple therapy, budesonide/glycopyrrolate/formoterol fumarate (BUD/GLY/FORM), in a real-world setting.²

The researchers used data from the IQVIA PharMetrics Plus database, including patients aged 40 years and older who initiated either FF/UMEC/VI or BUD/GLY/FORM between October 1, 2020, and October 1, 2022. Adherence was measured as the proportion of days covered (PDC) and the proportion of adherent patients (PDC ≥ 0.8 and PDC ≥ 0.5) at both 6 and 12 months. Persistence was defined as no gaps of ≥ 30 days in therapy; inverse probability of treatment weighting was implemented to adjust for baseline differences.

A total of 11,597 patients were included, with 8912 initiating FF/UMEC/VI and 2685 initiating BUD/GLY/FORM. The mean ages were 64.6 years for FF/UMEC/VI and 64.0 years for BUD/GLY/FORM. At 6 and 12 months, mean PDC was significantly higher for FF/UMEC/VI (0.65 vs 0.59 and 0.57 vs 0.50, respectively; P < .001). The proportion of adherent patients (PDC ≥0.8) was also higher for FF/UMEC/VI at both 6 months (45.6% vs 34.5%) and 12 months (35.1% vs 24.8%).

Results showed patients initiating FF/UMEC/VI were 26% more likely to persist with treatment at 12 months compared with those initiating BUD/GLY/FORM (HR, 1.26; 95% CI, 1.20–1.33; P < .001).

According to the study, these data support the consideration of FF/UMEC/VI as a preferred option in COPD management to optimize patient adherence and persistence compared with BUD/GLY/FORM. The once-daily single-inhalation regimen of FF/UMEC/VI likely contributes to these improved outcomes, highlighting its potential to enhance treatment effectiveness, the researchers concluded.

As the data demonstrate, initiating FF/UMEC/VI therapy without delay reduces exacerbations, lowers health care costs, decreases hospital readmissions, and promotes adherence; these findings from ATS 2024 highlight the significant benefits of FF/UMEC/VI for patients with COPD.

"This study is the first real-world comparison of triple combination FF/UMEC/VI and BUD/FORM/GLY for COPD in the USA, and we demonstrated a significant difference in adherence and persistence favoring FF/UMEC/VI," Noorduyn wrote.

"Adherence in COPD remains a substantial challenge, and yet patients who are adherent to therapy could achieve short- and longer-term benefits of therapy, potentially even stabilization of their COPD. Further research is needed to better understand the clinical and patient benefits of improved adherence and persistence for long-term goals of COPD management."

References

1. Noorduyn S, Mannino D, Dirocco K, et al. An investigation on the effects of prompt versus delayed initiation of fluticasone furoate/umeclidinium/vilanterol single-inhaler triple therapy among patients with chronic obstructive pulmonary disease in the United States (abstract). Am J Respir Crit Care Med. 2024;209:A3302.

2. Noorduyn S, Young C, Lee L, et al. Adherence and persistence with fluticasone furoate/umeclidinium/vilanterol and budesonide/glycopyrrolate/formoterol fumarate among patients with chronic obstructive pulmonary disease: a real-world United States study (abstract). Am J Respir Crit Care Med. 2024;209:A3301.