IPF patients treated with OFEV^® (nintedanib) versus placebo were twice as likely to have improved or stable lung function¹

Ingelheim, Germany, May 24, 2017 – Boehringer Ingelheim today announced the presentation of new analyses on the use of OFEV^®(nintedanib) in treating idiopathic pulmonary fibrosis (IPF) at the 2017 American Thoracic Society (ATS) conference. Abstracts presented at the conference support the established efficacy and safety data for OFEV^®, and offer further insights into its effect on lung function in IPF patients. 

Pooled data from the two Phase III INPULSIS^® trials showed that OFEV^®-treated patients were twice as likely as those given placebo to experience an improvement or no decline in lung function, as measured by forced vital capacity (FVC), at week 52 (36.8%, OFEV^® vs. 18.0%, placebo).¹ A subgroup analysis of the open-label INPULSIS^®-ON study demonstrated a similar annual rate of FVC decline over 96 weeks among OFEV^®-treated patients, regardless of the dosage they received based on individual tolerability (150 mg twice daily, 100 mg twice daily, or both doses).²

Additionally, a pooled analysis from the TOMORROW^™ and INPULSIS^® trials assessed the incidence rates for major adverse cardiovascular events (MACE) among patients treated with OFEV^® and placebo. Most patients included in this analysis (90%) had a high cardiovascular (CV) risk at baseline, including a history of fatty-plaque build-up in the arteries (called atherosclerosis) and/or at least one CV risk factor such as high blood pressure, diabetes or elevated blood cholesterol levels. Overall, the incidence of MACE was similar between the treatment groups both in patients with a high CV risk (3.5%, OFEV^® and 3.3%, placebo) and low CV risk (4.5%, OFEV^® and 5.3%, placebo) at baseline.³

“IPF is a progressive disease that requires ongoing treatment. So it is important to assess the long-term efficacy and safety of IPF treatments like OFEV^® to ensure we are maintaining lung function and reducing disease progression while not exacerbating co-existing conditions,” said Imre Noth, M.D., professor of medicine and director of the Interstitial Lung Disease Program at the University of Chicago. “These new data help to further strengthen the science supporting the efficacy and safety of OFEV^® for up to 96 weeks of treatment, and offer physicians additional evidence to support their treatment decisions.”

New Insights about IPF Patients
A separate analysis presented at ATS examined data from the IPF-PRO patient registry at 18 pulmonary care sites to identify the clinical characteristics of IPF patients who have advanced lung function impairment. Most clinical studies have included IPF patients with mild to moderate lung function impairment, and investigators wanted to understand how patients with more advanced disease differed. Patients with advanced IPF at baseline had greater physical impairment versus patients with mild to moderate disease, including lower six-minute walk distance (320 feet vs. 397 feet). The more advanced IPF patients also had an increased prevalence of hypoxaemia (low blood oxygen), both at rest (36.6% vs. 7.4%) and while active (62.4% vs. 20.2%), requiring more supplemental oxygen, as well as a history of pulmonary arterial hypertension, or high blood pressure in the lungs (14.0% vs. 6.4%). In addition, health-related quality of life (HRQL) scores were significantly worse in those with advanced lung function impairment.⁶

“Boehringer Ingelheim remains committed to research in IPF with the goal of providing further medical advances for patients suffering from this devastating disease,” said Dr. Susanne Stowasser, M.D., Global Team Lead Medical Affairs ILD, Therapeutic Area Respiratory, Boehringer Ingelheim Pharma GmbH & Co KG. “Building on our recent medical progress, we are expanding our research and development activities to other fibrosing interstitial lung diseases to address the high unmet medical need of patients affected by these conditions.”

Ongoing research is being conducted for the treatment of OFEV^®in patients with IPF and other interstitial lung diseases. Nintedanib is also being investigated for the treatment of systemic sclerosis with associated interstitial lung disease (SSc-ILD), as well as progressive fibrosing interstitial lung disease (PF-ILD).^* Additionally, the first Phase IV trial following the approval of OFEV^® for the treatment of IPF is completed and will add evidence to the safety and tolerability of nintedanib with add-on pirfenidone. Results from the 12 week, randomised INJOURNEY^® trial will be presented at an upcoming international medical congress. 

The corresponding abstracts can be found within the online programme, here: https://cms.psav.com/ats2017/confcal

About IPF
IPF affects approximately 3 million people worldwide.^7,8 IPF is a rare and devastating disease with a median life expectancy after diagnosis of approximately 2-3 years.⁹

To find out more about IPF, visit Life with IPF and Boehringer Ingelheim IPF where amongst a range of materials, you’ll find our new IPF patient webinar.

About the INPULSIS^® trials
INPULSIS^®-1 and -2 are two global Phase III trials which evaluated the efficacy and safety of nintedanib in the treatment of idiopathic pulmonary fibrosis (IPF). The INPULSIS^® trials were identical in design, e.g., with matching dosing, inclusion criteria and endpoints. INPULSIS^® recruited a range of patient types – similar to those seen in clinical practice including patients with early disease (FVC > 90% pred), no honeycombing on HRCT and/or concomitant emphysema. Patients who completed the 52-week treatment period and a 4-week follow-up period in the INPULSIS^® trials were offered open-label treatment with OFEV^® as part of an extension trial to assess the long-term safety and tolerability of OFEV. The INPULSIS^®-ON (Clinicaltrial.gov trial identifier: NCT01619085) trial included 734 patients and is currently ongoing. 

About OFEV^® (nintedanib)
OFEV^® (nintedanib, is approved for the treatment of the rare lung disease IPF (idiopathic pulmonary fibrosis).^10,11,12 OFEV^® targets growth factor receptors, which have been shown to be involved in the mechanisms by which pulmonary fibrosis occurs. It is believed that nintedanib slows the decline in lung function by blocking the signalling pathways that are involved in fibrotic processes.^14,15,16 In animal models, the anti-fibrotic activity of nintedanib was shown to be independent of the cause of the fibrosing lung disease.¹⁶

About Boehringer Ingelheim
Innovative medicines for people and animals have for more than 130 years been what the research-driven pharmaceutical company Boehringer Ingelheim stands for. Boehringer Ingelheim is one of the pharmaceutical industry’s top 20 companies and to this day remains family-owned. Day by day, some 50,000 employees create value through innovation for the three business areas human pharmaceuticals, animal health and biopharmaceutical contract manufacturing. In 2016, Boehringer Ingelheim achieved net sales of around 15.9 billion euros. With more than three billion euros, R&D expenditure corresponds to 19.6 per cent of net sales.

Social responsibility comes naturally to Boehringer Ingelheim. That is why the company is involved in social projects such as the “Making More Health” initiative. Boehringer Ingelheim also actively promotes workforce diversity and benefits from its employees’ different experiences and skills. Furthermore, the focus is on environmental protection and sustainability in everything the company does. 

More information about Boehringer Ingelheim can be found on www.boehringer-ingelheim.com or in our annual report: http://annualreport.boehringer-ingelheim.com.

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