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Simple blood test combined with exacerbation history may help to identify when to add ICS to COPD treatment

Boehringer Ingelheim today announced a new post-hoc subanalysis of the WISDOM study that suggests only 4 out of 100 people with chronic obstructive pulmonary disease (COPD), who have a history of frequent exacerbations and raised eosinophil levels (≥400 cells/µL), may further benefit by adding inhaled corticosteroids (ICS, fluticasone propionate 500µg twice daily) to Spiriva® (tiotropium 18μg once daily) and a long-acting beta2-agonist (LABA, salmeterol 50μg twice daily) with regard to reducing exacerbation risk.1,3 Eosinophils, which are a type of white blood cell, are assessed as part of a routine blood test.4 This new post-hoc subanalysis was presented today at the European Respiratory Society (ERS) International Congress 2016 in London.

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“New results from the WISDOM study indicate that using ICS as part of a triple therapy regimen in COPD maintenance treatment reduces the likelihood of an exacerbation for a smaller number of people than previously thought. It challenges our current understanding of the appropriate use of ICS in COPD maintenance therapy,” said study investigator Professor Peter Calverley, Professor of Pulmonary Medicine, University of Liverpool, UK. “These study results add important information to a debate that has potentially wide-ranging implications for the future treatment of people with COPD.”

Exacerbations significantly contribute to the impact of COPD, often leading to the person being admitted to a hospital,5 and can increase the risk of death.6 The Global Initiative for Chronic Obstructive Lung Disease (GOLD), which is a collaboration between the World Health Organization and the US National Institutes of Health, recommends the use of ICS-containing therapy only in people with COPD who have severe to very severe lung function impairment and/or are at high risk of exacerbations (GOLD C/D) or who have had a hospitalisation7 – the patient population studied in WISDOM. However, ICS are widely used outside of GOLD treatment recommendations in combination with bronchodilators, such as tiotropium and LABAs, in the treatment of COPD.8

This new post-hoc subanalysis suggests that by combining history of frequent exacerbations (two or more exacerbations in the past twelve months) with raised blood eosinophil levels of ≥400 cells/µL, healthcare providers may more precisely identify the minority of people with COPD who could experience a further exacerbation risk reduction from ICS (fluticasone propionate) on top of tiotropium and a LABA (salmeterol).1,3

This finding further builds on an earlier post-hoc analysis of the WISDOM trial, which evaluated blood eosinophil levels alone, and indicated that people with blood eosinophil levels higher than ≥300 cells/µL had an additional exacerbation reduction from ICS (fluticasone propionate) on top of tiotropium and a LABA (salmeterol).2

The 52-week WISDOM study (NCT00975195) evaluated the effect of ICS (fluticasone propionate) withdrawal in people with severe to very severe COPD having a history of exacerbation, while receiving tiotropium and a LABA (salmeterol).9 The patient population of the WISDOM trial represents approximately 20 percent of the normal COPD patient population10 and only 4 percent of this population were known to have a history of frequent exacerbations (two or more exacerbations in the past twelve months) with raised blood eosinophil levels of ≥400 cells/µL.1,3

“Boehringer Ingelheim is committed to continuing scientific research that informs the optimal treatment of people with COPD. These findings add to our understanding of the factors that should be considered by healthcare providers when deciding a treatment regimen for people with COPD – specifically when to add an ICS,” said Dr William Mezzanotte, Vice President and Head of Respiratory Medicine at Boehringer Ingelheim. “In addition, these findings highlight the importance of further investigation and discussion of this topic.”

In the WISDOM study population, complete ICS (fluticasone propionate) withdrawal was associated with a small reduction in trough FEV1 .9 The earlier post-hoc analysis showed overall no relationship between blood eosinophil count and change in lung function with ICS (fluticasone propionate) withdrawal.2 However, the latest post-hoc subanalysis indicated a relevant reduction in trough FEV1 in the small subgroup of people with high eosinophil count and frequent exacerbations.11

COPD is a serious but manageable lung disease, which is estimated to affect 210 million people worldwide.12 Total deaths from COPD are projected to increase by more than 30 percent in the next 10 years; COPD is predicted to become the third leading cause of death globally by 2030.13

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