New analyses presented at ATS 2016 further add to the efficacy and safety profile of Ofev (nintedanib) in idiopathic pulmonary fibrosis (IPF). In total, Boehringer Ingelheim presented 12 IPF-related abstracts at ATS, including further analyses of the INPULSIS trials, which add to the growing body of evidence reinforcing the clinical benefit of Ofev across a range of patients by showing that:
- Ofev slowed disease progression in a composite endpoint of lung function decline (forced vital capacity, or FVC, decrease >10%) and death.
- Ofev slowed lung function decline independent of disease severity as measured by GAP stage (patient’s gender, age or disease physiology) at baseline.
- Ofev significantly reduced the risk of a first investigator-reported acute exacerbation (reported as a serious adverse event) by 43% versus placebo based on pooled data from the INPULSIS trials.
- One-year data from post-marketing surveillance, including real-world clinical data from 6,700 patients taking Ofev, further confirmed the safety and tolerability profile seen in studies.
“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 III 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.”