GlaxoSmithKline (GSK) and Innoviva recently presented positive results from two analyses of the SUMMIT trial, which investigated the efficacy and safety of Breo Ellipta (fluticasone furoate/vilanterol, or FF/VI 100/25 mcg) in patients with chronic obstructive pulmonary disease (COPD) with moderate airflow limitation.
Breo Ellipta is an inhaled corticosteroid (ICS)/long-acting beta2 agonist combination (LABA). It is FDA-approved in the U.S. for the long-term, once-daily maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema, as well as for the reduction of exacerbations in COPD patients.
In Europe, FF/VI 100/25 mcg, sold under the brand name Relvar Ellipta, is approved for the symptomatic treatment of adult COPD patients with a forced expiratory volume in one second (FEV1, a measure of lung function) less than 70 percent predicted normal (post-bronchodilator) with an exacerbation history despite regular bronchodilator therapy.
Results from the analyses of the SUMMIT study, titled ”The impact of vilanterol, fluticasone furoate, or their combination on exacerbations in COPD patients with moderate airflow obstruction: the SUMMIT trial,” were presented at the American Thoracic Society 2016 International Conference May 13-18 in San Francisco.
The SUMMIT trial, which enrolled 16,568 patients, was designed to evaluate the effect, compared with placebo, of FF/VI 100/25 mcg once-daily on the mortality in patients with moderate COPD who had, or were, at high risk for cardiovascular disease (CVD).
The first analysis focused on the effect of the drug on COPD exacerbations. Results indicated that treatment with the inhaled drug decreased by 20 percent the risk of a COPD exacerbation, as measured by time to first exacerbation. Importantly, FF/VI 100/25 mcg reduced by 29 percent the rate of a moderate to severe exacerbation of COPD compared with placebo.
The second analysis focused on reported pneumonia events, of which rates were similar between the medicine and placebo groups. Reported pneumonia related adverse-events on FF/VI 100/25 mcg were 6 percent compared with placebo 5 percent; reported pneumonia-related serious adverse-events on FF/VI 100/25 mcg were 3 percent compared with placebo 3 percent.
“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,” said Dr. Courtney Crim, director of clinical development, R&D Respiratory at GSK, in a press release.
“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 [inhaled corticosteroids]-containing treatment arms. The finding from this study is therefore interesting and will require further investigation,” Crim said.
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