New analysis shows only minority of COPD patients may benefit from inhaled corticosteroids

Boehringer IngelheimBoehringer Ingelheim has announced a new publication showing that levels of white blood cells called eosinophils can help identify patients with COPD who may and may not benefit from the addition of ICS treatment. (1) In WISDOM, for 80 percent of patients, the use of ICS on top of Spiriva® and a LABA had no additional benefit in reducing the risk of exacerbations or 'flare-ups,' compared to Spiriva® and a LABA without ICS. The post-hoc analysis shows that these patients can be easily identified by measuring the level of eosinophils in their blood. Patients with levels lower than 4 percent (300 cells/µL) had no additional exacerbation benefit with the inclusion of ICS in their regimen.

Exacerbations significantly contribute to the impact of COPD, often lead to the patient being admitted to hospital,(2) and can increase the risk of a patient dying.(3) GOLD recommends the use of ICS-containing therapy only in COPD patients with severe to very severe lung function impairment and/or at high risk of exacerbations (GOLD C/D)4 - the patient population studied in WISDOM. Even within this severe population, only a small minority of patients in the study benefited from the inclusion of ICS to reduce their exacerbation risk.(1) It is recognised that long term use of ICS treatments may be associated with a risk of serious side effects including pneumonia, osteoporosis and diabetes onset and progression.(5,6,7)

The WISDOM post-hoc analysis demonstrates that using the simple and commonly performed eosinophil blood count may provide a practical tool to help doctors identify the small subset of patients who may benefit from the addition of ICS to Spiriva+LABA therapy. This post-hoc analysis is published online in the journal The Lancet Respiratory Medicine.

"Long acting bronchodilators are a mainstay therapy in COPD management, however in clinical practice ICS is widely used across all COPD stages," said study investigator Peter Calverley, Professor of Pulmonary and Rehabilitation Medicine, University of Liverpool, UK. "Previously, it has been difficult to determine the subset of patients who respond to ICS. These findings will help physicians more confidently identify which patients may benefit from ICS therapy, helping minimise exposure to the risk of side effects related to long-term ICS use."

The 52-week, large-scale WISDOM study evaluated the effect of ICS withdrawal in patients with severe to very severe COPD with a history of exacerbation, while receiving Spiriva® and a LABA.(8) This new post-hoc analysis from WISDOM found that the 20 percent of patients who benefited from a reduced exacerbation risk due to the continued use of ICS on top of a combination of Spiriva® with a LABA had higher levels of blood eosinophils (≥300 cells/µL; more than 4 percent).(1)

"These results are thought-provoking and add to the current debate about the appropriate use of ICS therapy in COPD," said Dr William Mezzanotte, Vice President and Head of Respiratory Medicine at Boehringer Ingelheim. "We look forward to further discussion and investigation of this important topic."

Future prospective studies are needed to provide further evidence to confirm these findings. In the WISDOM study population, complete ICS withdrawal was associated with a small reduction in trough FEV1. No relationship was observed between blood eosinophil count and change in lung function with ICS withdrawal.

COPD is a serious but manageable lung disease, which is estimated to affect 210 million patients worldwide.(9) 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 by 2(030.10)

About COPD
For people with COPD, decreasing lung function causes breathlessness and stops them from being active. This can lead to a downward spiral of worsening symptoms and even further inactivity,(11) contributing to an increased risk of disability and death.(12)

About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally with 146 affiliates and a total of more than 47,700 employees. The focus of the family-owned company, founded in 1885, is researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine.

Social responsibility is an important element of the corporate culture at Boehringer Ingelheim. This includes worldwide involvement in social projects, such as the initiative "Making more Health" and caring for the employees. Respect, equal opportunities and reconciling career and family form the foundation of the mutual cooperation. In everything it does, the company focuses on environmental protection and sustainability.

In 2014, Boehringer Ingelheim achieved net sales of about 13.3 billion euros. R&D expenditure corresponds to 19.9 per cent of its net sales.

1. Watz H et al. Blood eosinophil count and exacerbations in severe chronic obstructive pulmonary disease after withdrawal of inhaled corticosteroids: a post-hoc analysis of the WISDOM trial. Lancet Respir Med 2016. Available at http://www.thelancet.com/journals/lanres/article/PIIS2213-2600(16)00100-4/abstract [last accessed April 2016]
2. Anzueto A. Impact of exacerbations on COPD. Eur Respir Rev 2010; 19 (116); 113-118
3. Gunen H, et al. Factors affecting survival of hospitalised patients with COPD. Eur Respir J 2005; 26 (2); 234-241
4. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global Strategy for the Diagnosis, Management and Prevention of COPD. 2015. Available at http://www.goldcopd.org/ [last accessed April 2016]
5. Cates C. Inhaled corticosteroids in COPD: quantifying risks and benefits. Thorax 2013; 68: 499-500
6. Price D, et al. Risk-to-benefit ratio of inhaled corticosteroids in patients with COPD Prim Care Respir J 2013; 22(1): 92-100
7. Suissa S, et al. Inhaled corticosteroids and the risks of diabetes onset and progression. Am J Med 2010; 123: 1001-06
8. Magnussen H, et al. Withdrawal of inhaled glucocorticoids and exacerbations of COPD. N Engl J Med 2014; 371: 1285-94
9. WHO. Global Alliance Against Chronic Respiratory Diseases. Chronic Respiratory Diseases. Available at http://www.who.int/gard/publications/chronic_respiratory_diseases.pdf [last accessed April 2016]
10. WHO. Chronic respiratory diseases, Burden of COPD. Available at http://www.who.int/respiratory/copd/burden/en/index.html [last accessed April 2016]
11. Reardon JZ, et al. Functional status and quality of life in chronic obstructive pulmonary disease. Am J Med 2006; 119: 32-37
12. Casaburi R. Activity promotion: a paradigm shift for chronic obstructive pulmonary disease therapeutics. Am Thorac Soc 2011; 8(4):334-37

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