The Lancet Respiratory Medicine:New analysis shows only minority of COPD patients may benefit from inhaled corticosteroids

• New post-hoc analysis shows routine eosinophil blood test could help identify the small group of severe/very severe patients who may benefit from addition of ICS*

• Only 20 percent of patients in WISDOM^† study¹ benefited from addition of ICS on top of Spiriva^®‡ and a LABA^§ with regards to exacerbation risk reduction

• Data, published in The Lancet Respiratory Medicine, adds to current debate about appropriate selection of patients for ICS treatment in chronic obstructive pulmonary disease (COPD)

INGELHEIM, Germany--(BUSINESS WIRE)--Boehringer Ingelheim today 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 2030.¹⁰

For the full results please refer to The Lancet Respiratory Medicine paper here: http://www.thelancet.com/journals/lanres/article/PIIS2213-2600(16)00100-4/abstract

For ‘Notes to Editors’ and ‘References’ please visit: http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2016/08_april_2016_copd.html

* Inhaled corticosteroids

^† Withdrawal of Inhaled Steroids During Optimised Bronchodilator Management

^‡ Once-daily tiotropium 18µg administered via HandiHaler® (tiotropium bromide inhalation powder)

^§ Long-acting beta2-agonist

^** Twice-daily salmeterol 50µg