Simple Blood Test Combined with Exacerbation History May Help to Identify When to Add ICS to COPD Treatment

RIDGEFIELD, Conn., September 5, 2016 - Boehringer Ingelheim today announced a new post-hoc sub-analysis of the WISDOM* study. It suggests that only 4 in 100 people of the study population – with a history of frequent exacerbations and raised eosinophil levels (≥400 cells/µL) – may benefit by adding ICS to SPIRIVA^® HANDIHALER^® (tiotropium bromide inhalation powder) and a long-acting beta2-agonist (salmeterol) to further reduce the risk of exacerbations.

Eosinophils, which are a type of white blood cell, are assessed as part of a routine blood test. This new sub-analysis was presented today at the European Respiratory Society (ERS) International Congress 2016 in London.

“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 and Rehabilitation 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 hospitalizations and contributing to the risk of death. 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 treatment only in people with COPD who have severe to very severe lung function impairment and/or are at high risk of exacerbations or who have had a hospitalization (GOLD C/D) – the patient population studied in WISDOM. However, ICS treatments are widely used outside of GOLD treatment recommendations in combination with bronchodilators, such as tiotropium and salmeterol, in the treatment of COPD.

This new sub-analysis suggests that by combining a patient 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 benefit from the addition of ICS on top of tiotropium and salmeterol for further exacerbation risk reduction.

This finding builds on an earlier sub-analysis of the WISDOM trial that evaluated blood eosinophil levels alone and indicated that people with blood eosinophil levels higher than ≥300 cells/µL benefitted from the addition of ICS on top of tiotropium and salmeterol in reducing the risk of an exacerbation.

The 52-week WISDOM study (NCT00975195) evaluated the effect of ICS withdrawal in people with severe to very severe COPD having a history of exacerbation, while receiving tiotropium and salmeterol. The patient population of the WISDOM trial represents approximately 20 percent of the normal COPD patient population and only 4 percent of this study population was 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.

“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, 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 withdrawal was associated with a small reduction in trough FEV1. A prior post-hoc analysis showed overall no relationship between blood eosinophil count and change in lung function with ICS withdrawal. However, the latest post-hoc analysis indicated a relevant reduction in trough FEV1 in the small subgroup of people with high eosinophil count and frequent exacerbations.

About COPD
Chronic obstructive pulmonary disease (COPD) is a term including chronic bronchitis and/or emphysema. This disease can make breathing harder because less air is able to flow in and out of the lungs. Chronic lower respiratory diseases, which include COPD, are the third leading cause of death in the United States, and approximately 15 million Americans have been told by a healthcare provider that they have COPD.

The most common symptom of COPD is shortness of breath, especially with physical activities. Coughing, with or without mucus production, is also a common symptom of COPD. These symptoms can be misunderstood as signs of aging. COPD is usually associated with progressive airway damage and loss that cause breathing to get more difficult.

Indication
SPIRIVA HANDIHALER (tiotropium bromide inhalation powder) is a prescription medicine used once each day (a maintenance medicine) to control symptoms of chronic obstructive pulmonary disease (COPD) by relaxing your airways and keeping them open. COPD includes chronic bronchitis, emphysema, or both. SPIRIVA HANDIHALER also reduces the likelihood of flare-ups and worsening of COPD symptoms (COPD exacerbations).

Important Safety Information
Do not use SPIRIVA HANDIHALER if you are allergic to tiotropium, ipratropium, atropine or similar drugs, or any ingredient in this medicine.

SPIRIVA HANDIHALER is not a rescue medicine and should not be used for treating sudden breathing problems. Your doctor may give you other medicine to use for sudden breathing problems.

SPIRIVA HANDIHALER can cause allergic reactions. Symptoms can include raised red patches on your skin (hives), itching, rash, and/or swelling of the lips, tongue, or throat that may cause difficulty in breathing or swallowing. If you have any of these symptoms, stop taking the medicine and seek emergency medical care.

Before using SPIRIVA HANDIHALER, tell your doctor if you have a severe allergy to milk proteins.

SPIRIVA HANDIHALER can cause your breathing to suddenly get worse (bronchospasm). If this happens, use your rescue inhaler, stop taking SPIRIVA HANDIHALER, and call your doctor right away or seek emergency medical care.

SPIRIVA HANDIHALER can increase the pressure in your eyes (acute narrow-angle glaucoma), which can cause the following symptoms: eye pain, blurred vision, seeing halos or colored images along with red eyes. If you have any of these symptoms, stop taking your medicine and call your doctor right away.

Dizziness and blurred vision may occur with SPIRIVA HANDIHALER. If you experience these symptoms, use caution when engaging in activities such as driving a car, or operating appliances, or machinery.

SPIRIVA HANDIHALER can cause new or worsened urinary retention. Symptoms of blockage in your bladder, and/or enlarged prostate, may include difficulty passing urine and/or painful urination. If you have any of these symptoms, stop taking your medicine and call your doctor right away.

The most common side effects with SPIRIVA HANDIHALER include upper respiratory tract infection, dry mouth, sinus infection, sore throat, non-specific chest pain, urinary tract infection, indigestion, runny nose, constipation, increased heart rate and blurred vision.

Tell your doctor about all your medical conditions including kidney problems, glaucoma, enlarged prostate, problems passing urine, or blockage in your bladder.

Tell your doctor all the medicines you take, including eye drops. Ask your doctor if you are taking any anticholinergic medicines because taking them together can increase side effects.

Do not swallow SPIRIVA capsules. The contents of the capsule should only be inhaled through your mouth using the HANDIHALER device.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please click for full Prescribing Information and Instructions for Use for SPIRIVA HANDIHALER.

About Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation.

Boehringer Ingelheim is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with 145 affiliates and more than 47,000 employees. Since its founding in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel treatments for human and veterinary medicine.

Boehringer Ingelheim is committed to improving lives and providing valuable services and support to patients and their families. Our employees create and engage in programs that strengthen our communities. To learn more about how we make more health for more people, visit our Corporate Social Responsibility Report.

In 2015, Boehringer Ingelheim achieved net sales of about $15.8 billion (14.8 billion euros). R&D expenditure corresponds to 20.3 percent of its net sales.

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* Withdrawal of Inhaled Steroids During Optimized Bronchodilator Management

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