GlaxoSmithKline (GSK) recently presented new data from a pre-specified analysis of the SUMMIT clinical trial, showing that once daily treatment with Breo Ellipta (fluticasone furoate/vilanterol) reduced exacerbations in chronic obstructive pulmonary disease (COPD) patients compared to placebo. The presentation was one of two given at the American Thoracic Society (ATS) 2016 International Conference in San Francisco, California.
Breo Ellipta is an inhaled corticosteroid/long-acting beta agonist combination (ICS/LABA).
SUMMIT (Study to Understand Mortality and MorbidITy) was a Phase 3 trial multicenter, double-blind and randomized, parallel group study. It evaluated the effects of Breo Ellipta (fluticasone furoate/vilanterol, or FF/VI, 100/25mcg), when administered once a day via the Ellipta dry powder inhaler, on all-cause mortality in COPD patients with moderate airflow limitation and who had, or were at risk of, cardiovascular disease (CVD). Results announced in 2015 showed that the primary endpoint — all-cause mortality — was not affected by the combination therapy or its individual components.
The new analysis, the first presented at ATS, investigated the risk of a COPD exacerbation — as measured by time to first exacerbation — in patients treated with FF/VI 100/25mcg. Results found that the combination decreased the risk of a COPD exacerbation by 20% and reduced the rate of moderate-to-severe exacerbations by 29%, in comparison to placebo.
Earlier analysis of the study’s primary endpoint found a 12.2% reduction in the risk of dying compared to placebo, but that finding was not significant.
The second analysis found similar rates of pneumonia among the 16,568 patients enrolled in the SUMMIT trial, whether they were treated with FF/VI or placebo. Specifically, all reported pneumonia-related adverse effects in people given FF/VI were 6% and 5% in those receiving placebo, and pneumonia-related serious events were 3% in the treated arm versus 3% in the placebo arm.
COPD, now the third leading cause of death worldwide, often coexists with other chronic diseases, and recent epidemiological data suggests that CVC or its risk exists in nearly 50% of all COPD patients. Indeed, CVD is the leading killer of mild-to-moderate COPD patients. In studies extending up to 15 years, patients with CVD and COPD were found to have a mortality rate two times higher than COPD patients without CVD.
“We believe these data are important for COPD physicians and are clinically relevant. 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 placebos,” Dr. Courtney Crim, GSK’s director of Clinical Development and Research and Development Respiratory, said in a press release. “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.”