GSK data presented at ERS demonstrate potential of blood eosinophil levels to help inform COPD treatment decisions

GSK today presented data at the European Respiratory Society (ERS) Congress that show blood eosinophil levels may help predict those patients with COPD who will have a greater reduction in exacerbation rates when receiving an inhaled corticosteroid (ICS) containing regimen, and could potentially be used in the future, if supported by further studies, to help physicians tailor their treatment decisions.

A number of scientific studies have suggested that eosinophils (a type of white blood cell), although primarily associated with asthma, may also influence and be associated with an increased risk of exacerbations among patients with COPD. To explore whether measuring and stratifying patients by blood eosinophil levels could help identify those patients who are likely to derive the most benefit from a particular treatment, GSK undertook a post-hoc analysis of data from almost 8,000 patients to explore whether there was a differential response to treatment based on eosinophil levels measured at study start.

Data were analysed from studies undertaken as part of the development of Relvar® Ellipta® (fluticasone furoate/vilanterol or FF/VI), an inhaled corticosteroid/long-acting beta2 agonist combination (ICS/LABA) and its individual components, and also Anoro® Ellipta® (umeclidinium/vilanterol or UMEC/VI), a long-acting muscarinic antagonist/long-acting beta2 agonist (LAMA/LABA) and its individual components.

The findings from each study were as follows:

• Blood eosinophil count as a biomarker of ICS effectiveness in reducing exacerbation rates in COPD (Pascoe S, Locantore N, Dransfield MT, Pavord ID) – P2817

Post-hoc analysis of data from two randomised, double-blind, placebo-controlled 1-year trials comparing exacerbation rates in patients with moderate to severe COPD, showed that in the subgroup with an eosinophil level ≥2%, exacerbation rates were reduced by 29% (p<0.001) in those treated with FF/VI all doses (50/25mcg, 100/25mcg and 200/25mcg) compared to VI (25mcg) alone. In patients with an eosinophil level of <2% a decrease of 10% (p=0.283) was observed between those receiving FF/VI and those receiving VI.

Results from this analysis suggest that baseline eosinophil levels might predict improvement in exacerbation rates in patients taking FF/VI compared to VI alone and that the magnitude of improvement is likely to be greatest in those with the highest levels of eosinophils.

• Is blood eosinophil count a predictor of response to bronchodilators in COPD? (Iqbal A, Barnes NC, Brooks J) P2819

Post-hoc analysis of data from four 6-month studies of UMEC/VI (62.5/25mcg and 125/25mcg) and VI (25mcg) found that response to treatment with UMEC, VI or UMEC/VI, evaluated by bronchodilator response, health-related quality of life or dyspnoea, were similar when stratified by blood eosinophil levels ≥2% or <2% at baseline.

Results from this analysis suggested that blood eosinophils levels are not predictive of a bronchodilator response.

Neil Barnes, Global Franchise Medical Head, Respiratory, GSK said: “COPD is a heterogeneous disease and enhancing our understanding of how individual patients respond to different treatments is critical to allow treatment to be tailored to their specific needs, with the ultimate aim of improving outcomes.

“These data, and those from other studies, are very valuable and support our belief that these circulating white blood cells could play an important role in guiding effective COPD management. We believe it is important that further work, including prospective studies, is undertaken to generate more evidence about the promising role of blood eosinophil levels as an indicator of response to an ICS-containing regimen.”

Further analysis of existing data and also prospective studies are needed to substantiate these findings and provide further scientific data regarding the role of the eosinophil in COPD, as well as help inform the most appropriate use of our medicines. GSK is committed to working with the scientific community and exploring this further, including prospective eosinophil data collection from the large-scale phase III Closed Triple study of FF/UMEC/VI, known as IMPACT.