● Separate subgroup analysis demonstrates long-term efficacy of OFEV® in slowing disease progression is maintained for up to 96 weeks in patients who require dose adjustments to manage adverse events2
● An additional pooled analysis where the majority of patients (90%) had high cardiovascular (CV) risk showed the incidence of major adverse CV events was low and comparable between OFEV® and placebo-treated patients3
INGELHEIM, Germany-Wednesday, May 24th 2017 [ ME NewsWire ]
(BUSINESS WIRE)-- 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
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