Lancet Publication: New Analysis Demonstrates Only Small Minority of Severe/Very Severe COPD Patients May Benefit from Adding ICS to SPIRIVA^® HANDIHALER^® (tiotropium bromide inhalation powder) + LABA Therapy

RIDGEFIELD, Conn., April 8, 2016 – 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. For 80 percent of patients in the WISDOM study, the use of ICS on top of SPIRIVA^® HANDIHALER^®‡ and a LABA^** had no additional benefit in reducing the risk of exacerbations or ‘flare-ups,’ compared to SPIRIVA^® HANDIHALER^®‡ 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) were associated with a lack of response to ICS.

Exacerbations significantly contribute to the impact of COPD, often lead to the patient being admitted to hospital, and can increase the risk of a patient dying. 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) – 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 in their treatment regimen. It is recognized 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.

The WISDOM post-hoc analysis demonstrates that using the simple and commonly performed eosinophil blood count may provide a practical tool to help healthcare providers identify the small subset of patients who may benefit from the addition of ICS to SPIRIVA^® HANDIHALER^®‡+ LABA therapy. This post-hoc analysis is published online in the journal 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 minimize exposure to the risk of long-term side effects of 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^® HANDIHALER^®‡ and a LABA. This new post-hoc analysis from WISDOM found that the 20 percent of patients who benefited from the continued use of ICS on top of a combination of SPIRIVA^® HANDIHALER^®‡ with a LABA had raised levels of blood eosinophil (≥300 cells/µL; ≥4 percent).

“These results further inform the current debate about the appropriate role of ICS in the treatment of COPD,” said Danny McBryan, MD, vice president, Clinical Development & Medical Affairs, Respiratory, Boehringer Ingelheim Pharmaceuticals, Inc. “Boehringer Ingelheim has an ongoing commitment to help healthcare providers and patients better understand how to optimally treat COPD. We look forward to additional studies on this topic to provide us with more information.”

Future prospective studies are needed to provide further evidence to confirm these findings. For all subgroups, ICS withdrawal was associated with a decrease in trough FEV₁. No relationship was observed between blood eosinophil count and change in lung function with ICS withdrawal.

Indication

SPIRIVA HANDIHALER 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 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.

Leading Respiratory Forward

Through research, treatments and patient-centric support services, the Boehringer Ingelheim (BI) lung health portfolio is designed to help address the challenges people living with a lung disease face every day. Leveraging the company's cutting edge science and leadership in chronic obstructive pulmonary disease (COPD), BI is researching new treatment approaches where needs persist. It is the company's goal to make a difference in the lives of patients with COPD, asthma, lung cancer, idiopathic pulmonary fibrosis and other respiratory diseases.

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 146 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 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 2014, Boehringer Ingelheim achieved net sales of about $16.96 billion dollars (13.3 billion euros). R&D expenditure corresponds to 19.9 percent of its net sales.

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