Findings from a recent study published in The Lancet journal entitled “Blood eosinophil counts, exacerbations, and response to the addition of inhaled fluticasone furoate to vilanterol in patients with chronic obstructive pulmonary disease: a secondary analysis of data from two parallel randomized controlled trials“ reveals that individuals suffering with chronic obstructive pulmonary disease (COPD) and high blood eosinophil can significantly benefit from the utilization of inhaled corticosteroids since they reduce the exacerbation frequency in comparison to patients with low eosinophil count.
Steven Pascoe from GlaxoSmithKline (GSK) and research colleagues wrote in a press release: “Our findings have immediate clinical implications as they show that blood eosinophil count, a readily available and easy to interpret measure, is potentially suitable for use as a biomarker to identify which patients are most likely to benefit from inhaled corticosteroids.”
Scientists conducted a data evaluation from two randomized, replicate, double blind, 12-month trials held between September 2009 and October 2011. The once-daily 25 µg Breo Ellipta (vilanterol, GlaxoSmithKline) was compared with 25 µg vilanterol plus 50 µg, 100 µg or 200 µg fluticasone furoate in patients suffering from moderate to severe COPD.
3,177 patients were included in the analysis. When the study began, 66 percent of patients had blood eosinophil counts of 2 percent or higher. Comparing the combination therapies with vilanterol alone, the research team found that patients with eosinophil counts of 2 percent had a decrease of 29 percent in COPD exacerbations.
COPD exacerbations decreased 10 percent in individuals who had eosinophil counts lower than 2 percent and received the combination therapy vs. vilanterol alone.
“Patients with mild or no history of exacerbation in the previous year were not included in the study, therefore, we cannot comment on the usefulness of eosinophil count as a biomarker in these patients. Our analysis … supports the view that the use of blood eosinophil cell counts as a biomarker of inhaled corticosteroid response would result in an improved risk-benefit ratio for this treatment,” the researchers concluded.
In other GSK-related news, the U.S. Food and Drug Administration (FDA) ruled against the use of GlaxoSmithKline‘s new drug combination Breo Ellipta in asthma patients between the ages of 12 and 17. However, the Pulmonary-Allergy Drugs Advisory Committee and the FDA’s Risk Management Advisory Committee approved the therapy’s supplemental New Drug Application (sNDA) in patients older than 17.