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Home Research & Development News New presentations at ATS 2016 reinforce OFEV efficacy, safety and tolerability across range of patients with IPF
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16 May 2016

New presentations at ATS 2016 reinforce OFEV efficacy, safety and tolerability across range of patients with IPF

A new analysis of Phase III INPULSIS trials reinforces OFEV's slowing of disease progression in a composite endpoint involving lung function decline (FVC decrease >10%) and death.

New analyses presented at the American Thoracic Society's 2016 annual conference (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, 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."

    The new analyses from the pooled Phase III INPULSIS trials 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 a composite endpoint of worsening in lung function (absolute decline in FVC >10%) or death over 52 weeks. Furthermore, the analyses showed there was a consistent reduction in disease progression across a range of patients defined by baseline FVC.

  • OFEV's clinical benefit was consistent across subgroups. OFEV slowed the decline in lung function regardless of the patient's GAP stage (gender, age and disease physiology) at baseline.

  • OFEV significantly reduced the risk for time to first acute exacerbations reported by investigators as serious adverse events 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. Acute exacerbations reported as serious adverse events were associated with a higher risk of death than acute exacerbations reported as non-serious adverse events.

  • One-year data on adverse events collected from more than 6,700 US OFEV patients from post-marketing surveillance, including real-world clinical data, was consistent with those seen in the pivotal clinical trials. No new safety concerns or unexpected safety signals were observed.

    • "Boehringer Ingelheim is committed to furthering science that addresses the unmet needs of people with rare diseases where limited treatments exist," said Danny McBryan, vice president, Clinical Development and Medical Affairs, Respiratory, 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."

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