Breo Ellipta Proves Non-inferior to Asthma Therapies, Affordable for COPD with CV Risks

Two separate studies have indicated that fluticasone furoate (FF)/ vilanterol (VI) (Breo Ellipta) is both consistent to a comparative controlled asthma therapy, and a cost-effective therapy for chronic obstructive pulmonary disease (COPD) patients with cardiovascular (CV) risks.

Both studies were presented back-to-back in a panel focused on respiratory care at the 2017 Annual CHEST Meeting in Toronto, ON, CA. Research team member Louisa Jane Yates, presented the data comparing once-daily Breo Ellipta with twice-daily fluticasone propionate (FP)/salmeterol (SAL) (Diskus).

In a study funded by GlaxoSmithKline, researchers evaluated Breo Ellipta once-daily 100/25mg dose as a possible non-inferior therapy to Diskus twice-daily 250/50mg in adult and adolescent patients with persistent asthma. The patients’ condition was required to be under control with a daily inhaled corticosteroid (ICS) plus long acting beta2-agonist (LABA) at a dose equivalent to Diskus twice-daily 250/50mg.

The 1:1:1 randomized, double-blind study featured 1,504 patients, Yates said, with 504 receiving Breo Ellipta, 501 receiving Diskus, and 499 receiving a sole FP therapy. For 24 weeks, Breo Ellipta patients were given 100/25mg once daily; Diskus patients were given 250/50mg twice daily; and FP patients received 250mg twice daily.

Both Breo Ellipta and Diskus patients reported a significantly greater forced expiratory volume over 1 second (FEV1) in evening pre-dose periods than FP. Compared with FP, Breo Ellipta reported a 2.7% increase in rescue inhaler-free 24-hour periods, while Diskus reported a 1.4% increase.

All 3 treatments reported a consistent rate of on-treatment adverse events (Breo Ellipta 45%; Diskus 43%; FP 44%) with no serious adverse events, and overall well tolerability.

Yates and researchers concluded that patients with well controlled asthma should be able to switch from twice-daily Diskus to once-daily Breo Ellipta without loss of control.

Breo Ellipta’s merit as an asthma and COPD therapy was only again bolstered by the next-presented study, in which researcher Ana Coutinho, MD, discussed her team’s discovery that the combination therapy is a potentially cost-saving option.

The US economic analysis used the within-trial data of the intent-to-treat population (ITTP) from the Study to Understand Mortality and Morbidity in COPD (SUMMIT). Gauging the data from the perspective of US healthcare system payer, the study compared 1-year costs of each active treatment comparator, Breo Ellipta 100/25mcg, FF 100mcg, and VI 25mcg versus placebo.

COPD exacerbation costs were configured through US managed care database estimates on unit cost, applied to the number of events occurring during each patient’s follow-up, Coutinho said. Unit costs were determined in a cohort of COPD patients with CV risk.

Researchers then computed COPD exacerbation costs for each treatment cohort with inverse probability treatment weighting (IPRTW) to account for censoring.

In the 16,485 subjects evaluated — with all 4 treatment cohorts accumulating about one-quarter of the rate — the 1-year average cost for moderate-to-severe exacerbations were significantly lower versus placebo, researchers noted.

Cost averages were: Breo Ellipta $2,468; FF $2,592; VI $2,708; and placebo $3,386.

With the greatest cost difference from placebo being found in Breo Ellipta, researchers concluded both clinicians and payers could be able to reduce costs in treating COPD patients with CV risks by treating for COPD — especially with FF/VI.