Safety and Efficacy Confirmed for Idiopathic Pulmonary Fibrosis Drug

Further analyses of the INPULSIS trials that added to the safety and efficacy profile of nintedanib (OFEV) in patients with idiopathic pulmonary fibrosis (IPF) were presented recently at the American Thoracic Society’s 2016 annual conference (ATS 2016).

Boehringer Ingelheim presented 12 abstracts related to IPF, including further analyses of the trials. This data helped reinforce the clinical benefit of OFEV across a range of patients, according to Boehringer Ingelheim.

OFEV was found to slow disease progression in a composite endpoint of forced vital capacity or lung function decline and death. It was also able to slow lung function decline, independent of disease severity, as measured by gender, age or disease physiology at baseline.

The risk of first investigator-reported acute exacerbation was reduced by 43% in patients taking OFEV versus the placebo in the INPULSIS trials.

The safety and tolerability profile seen in the studies was further confirmed by 1-year data from post-marketing surveillance, including real world clinical data from 6700 patients taking OFEV.

“IPF progression is variable and unpredictable, but, over time, the lung function of patients gradually and irreversibly declines,” said Imre Noth, MD, professor of medicine and director of the Interstitial Lung Disease Program at the University of Chicago. “Ongoing analyses of the Phase 3 INPULSIS trials along with real-world data provide additional support for the safety and efficacy of treatment with OFEV. As slowing disease progression is an important treatment goal, these data provide support for the benefit of IPF patients regardless of disease severity.”

The results of the new analyses presented at ATS 2016 showed that OFEV significantly reduced the risk of disease progression by 40% (27.1%, OFEV vs. 41.4%, placebo; p<0.0001), as measured by the composite endpoint of worsening lung function (absolute decline in FVC ≥10%) or death over a 52-week period. Additionally, there was a consistent reduction in disease progression among a range of patients defined by baseline FVC.

OFEV slowed the decrease in lung function, regardless of the patient’s GAP stage at baseline.

The risk for first investigator-reported acute exacerbation as serious adverse events was significantly reduced by 43% (3.6%, OFEV vs. 6.1%, placebo; p=0.0476) and 70% (1.6%, OFEV vs. 5%, placebo; p=0.0019) for serious adverse events adjudicated as confirmed or suspected acute exacerbations, respectively.

Acute exacerbations reported as serious adverse events were associated with a higher risk of death compared with those reported as non-serious adverse events.

“Boehringer Ingelheim is committed to furthering science that addresses the unmet needs of people with rare diseases where limited treatments exist,” said Danny McBryan, MD, vice president of Clinical Development and Medical Affairs, Respiratory, at Boehringer Ingelheim Pharmaceuticals, Inc. “Already, more than 10,000 patients worldwide have received treatment with OFEV to date, and we’re continually working to advance the understanding of IPF through our clinical trial program and ongoing research of OFEV in the real-world clinical setting.”