GlaxoSmithKline (GSK) presented new data at the American Thoracic Society (ATS) Conference from two pre-specified analyses from the Study to Understand Mortality and MorbidITy (SUMMIT) trial. One demonstrated that patients with COPD and moderate airflow limitation receiving Breo Ellipta (fluticasone furoate/vilanterol or FF/VI 100/25mcg) achieved improvements in exacerbations compared with placebo. The second analysis demonstrated these patients reported similar rates of pneumonia when taking FF/VI 100/25mcg compared with placebo.
The SUMMIT trial was designed to evaluate the effect of FF/VI 100/25mcg once-daily on all-cause mortality compared with placebo in patients with moderate COPD who had, or were at high risk for Cardiovascular Disease (CVD). Results of the primary endpoint were announced in 2015 and showed that all cause mortality was not affected by combination therapy or the individual components.
The first analysis presented investigated the impact of FF/VI 100/25mcg, an inhaled corticosteroid/long-acting beta2 agonist combination (ICS/LABA), on exacerbations in COPD patients with moderate airflow limitation (mean FEV1 60% predicted). In patients treated with FF/VI100/25mcg the risk of a COPD exacerbation, measured by time to first exacerbation, was decreased by 20% (HR 0.80, 95% confidence interval 0.73 – 0.86) versus placebo. In addition, FF/VI 100/25mcgled to a 29% reduction in the rate of a moderate to severe exacerbation of COPD compared with placebo.
A second analysis of all reported pneumonia events amongst the 16,568 patients in the SUMMIT trial showed that rates were similar for patients randomised to FF/VI 100/25mcg compared with those on placebo. Reported pneumonia related adverse-events on FF/VI 100/25mcg were 6% compared with placebo 5%, reported pneumonia related serious adverse-events on FF/VI 100/25mcg were 3% compared with placebo 3%.
“We believe these data are important for COPD physicians and are clinically relevant,” said Dr Courtney Crim, director Clinical Development, R&D Respiratory, GSK. “These findings from SUMMIT show that COPD patients with moderate airflow limitation experienced both a lower risk of having an exacerbation and fewer exacerbations when treated with FF/VI than patients on placebo. In the same patients with moderate airflow limitation we also saw a similar incidence of pneumonia in patients on FF/VI and those on placebo. In previous studies, in more severe patients, an increase in the incidence of pneumonias has been observed in ICS-containing treatment arms. The finding from this study is therefore interesting and will require further investigation.”