New Results From a Patient Registry Reveal Insights About Idiopathic Pulmonary Fibrosis (IPF)

Ridgefield, Conn. and Montreal, October 22, 2015 – Boehringer Ingelheim Pharmaceutical, Inc. today announced initial results of the first 49 people enrolled in the IPF-PRO Registry, which shed light on characteristics of people with IPF at the time of diagnosis.  Results will be presented at the American College of Chest Physicians Annual Meeting (CHEST 2015) on October 26 in Montreal, Canada.

The IPF-PRO Registry is an academic-industry alliance between Boehringer Ingelheim Pharmaceuticals, Inc. and the Duke Clinical Research Institute to better understand outcomes and disease progression for people with IPF, a rare and fatal lung disease.

“We are very excited to share this first look at real-world patients with IPF across 18 IPF academic centers in the United States. Over time, we look forward to helping the IPF community learn more about disease progression, quality of life and other outcomes that are important to patients,” said lead study author Michael Durheim, M.D., Medical Instructor, Department of Medicine, Duke Clinical Research Institute. “As this alliance continues, our objective is to advance the understanding of this devastating disease, through additional findings about diagnosis, treatment patterns and whether blood or genetic markers may impact patient outcomes.”

From an evaluation of the first 49 people with IPF enrolled in the registry (NCT01915511; abstract 362A), the results showed:

• Most people exhibited symptoms of IPF for more than a year before being diagnosed.
• By the time of enrollment, many people exhibited considerably impaired lung function, with a median forced vital capacity (FVC, or the amount of air that can be exhaled after maximum inhalation) of 72 percent (61 to 81 percent) predicted and diffusing capacity of carbon monoxide (DLCO, or the measure of the lungs’ ability to transfer oxygen to red blood cells) of 39 percent (34 to 48 percent) predicted.
• Twenty-nine percent (14 patients) required supplemental oxygen when resting, and 45 percent (22 patients) required supplemental oxygen during activities.
• Nearly all patients (98 percent, 48 patients) received an imaging test known as high resolution CT scan as part of their diagnosis, while 20 percent (10 patients) also underwent surgical biopsy to examine for signs of IPF.
• The most commonly reported comorbidities were gastroesophageal reflux disease (GERD) (69 percent), coronary artery disease (31 percent) and sleep apnea (29 percent).

“These results showed us that many patients already have significant respiratory impairment by the time they are diagnosed by a pulmonologist, which reinforces what we know from ongoing research,” said Danny McBryan, M.D., vice president, Clinical Development and Medical Affairs, Respiratory, Boehringer Ingelheim Pharmaceuticals, Inc. “The Registry emphasizes the critical need to recognize IPF earlier and send patients to a specialist faster to determine diagnosis and care.”

About IPF
Idiopathic pulmonary fibrosis (IPF) is characterized by inflammation and scarring of lung tissue and loss of lung function over time. Development of scarred tissue is called fibrosis. Over time, as the tissue thickens and stiffens with scarring, the lungs lose their ability to take in and transfer oxygen into the bloodstream, and vital organs do not get the oxygen they require. Individuals with IPF experience shortness of breath and often have difficulty participating in everyday physical activities.

Research indicates that IPF may affect as many as 132,000 people in the United States and the patient population may be increasing. Most patients with IPF die from the disease within three to five years of diagnosis.

About IPF-PRO
The Idiopathic Pulmonary Fibrosis – PROspective Outcomes (IPF-PRO) Registry is a prospective, multi-center effort designed to better understand the natural progression of, and treatment approaches for, idiopathic pulmonary fibrosis (IPF). IPF-PRO is a unique collaboration between Boehringer Ingelheim and the Duke Clinical Research Institute (DCRI) designed to build on the knowledge of single-center studies and clinical trials.

The five-year registry is actively recruiting 300 patients with IPF diagnosed at 18 centers specialized in treating lung disease. The primary measures include: characterizing and describing the natural history of recently-diagnosed patients; understanding current practice patterns; and describing the impact of IPF on patient quality-of-life. The registry also will include a biomarker bank to identify potential blood or genetic markers of the disease that correlate with patient outcomes.

For more information, please visit clinicaltrials.gov/ct2/show/NCT01915511.

About Boehringer Ingelheim
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.

For more information please visit www.us.boehringer-ingelheim.com, or follow us on Twitter @BoehringerUS.  

About Duke Clinical Research Institute
The Duke Clinical Research Institute (www.dcri.org) is the world’s largest academic clinical research organization. Duke Clinical Research Institute research spans multiple disciplines, from pediatrics to geriatrics, primary care to subspecialty medicine, and genomics to proteomics. The Duke Clinical Research Institute is also home to the Duke Databank for Cardiovascular Diseases, the largest and oldest institutional cardiovascular database in the world, which continues to inform clinical decision-making 40 years after its founding. The Duke Clinical Research Institute has conducted studies at more than 37,000 sites in 65 countries; completed more than 970 phase I-IV clinical trials, studies of patient outcomes and analyses of comparative effectiveness; managed national patient registries; enrolled more than 1.2 million patients in Duke Clinical Research Institute studies; and published more than 8,300 papers in peer-reviewed journals.
 

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