GSK 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

1. 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 per cent, exacerbation rates were reduced by 29 per cent (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 per cent a decrease of 10 per cent (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.

2. 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 per cent or <2 per cent 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.

Chronic obstructive pulmonary disease (COPD) is a disease of the lungs that includes chronic bronchitis, emphysema or both. COPD is characterised by obstruction to airflow that interferes with normal breathing.

Long-term exposure to lung irritants that damage the lungs and the airways are usually the cause of COPD. Cigarette smoke, breathing in second-hand smoke, air pollution, chemical fumes or dust from the environment or workplace can all contribute to COPD.iv Most people who have COPD are at least 40 years old when symptoms begin.

Eosinophils are a type of white blood cell thought to play a role in the development of allergic airway inflammation.

Although primarily associated with asthma, eosinophilic airway inflammation is present in some patients with COPD and has been shown to occur during exacerbations of COPD. A blood eosinophil count of =2 per cent has been suggested to identify a group of patients who show a greater response to corticosteroid treatment in COPD.

Please note that all doses listed above are specified as the pre-dispensed dose as reported in the abstracts, which are equivalent to the delivered dose (emitted from the inhaler). The approved dose within the European SmPC for Relvar Ellipta, Anoro and Incruse are all stated as the delivered dose.

Relvar Ellipta is a once-daily dual combination treatment comprising fluticasone furoate, an inhaled corticosteroid and vilanterol, a long-acting beta2-agonist, in a single inhaler, the Ellipta. For the EU Summary of Product Characteristics for Relvar Ellipta

Anoro Ellipta is a once-daily combination treatment comprising two bronchodilators: umeclidinium, a long-acting muscarinic antagonist, and vilanterol, a long-acting beta2 agonist, in a single inhaler, the Ellipta. For the EU Summary of Product Characteristics for Anoro.