MedicalResearch.com Interview with:
Kevin R. Flaherty, M.D., M.S.
Professor, Department of Internal Medicine
Associate Director, T32 Multidisciplinary Training Program in Lung Diseases
Chair, Pulmonary Fibrosis Foundation Clinical Care Network Steering Committee
University of Michigan Medicine
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: This is a new post-hoc analysis, recently presented at the 2017 American Thoracic Society (ATS) conference, which sought to further assess the efficacy of Ofev (nintedanib), an FDA-approved drug treatment for idiopathic pulmonary fibrosis (IPF), and its effect on lung function in those with this disease.
IPF is a rare and serious lung disease that causes permanent scarring of the lungs and affects as many as 132,000 Americans.
The analysis examined pooled data from the two placebo-controlled, global Phase III INPULSIS trials, which evaluated the efficacy and safety of 52 weeks’ treatment with nintedanib in people with IPF. In both trials, a higher proportion of people treated with placebo than nintedanib had disease progression from baseline to week 52, as defined by the proportions of patients with ≥5% or ≥10% declines in lung function, as measured by forced vital capacity (FVC) % predicted. Additionally, a lower proportion of patients treated with placebo than nintedanib had no decline or an improvement in FVC % predicted.
These data support the initial findings from the Phase III INPULSIS trials which found that more patients treated with nintedanib versus placebo had an absolute decline in FVC of less than 5%.
In this subgroup analysis, we assessed the proportions of patients from the two INPULSIS trials treated with nintedanib and placebo who had no decline or an improvement in lung function from baseline to week 52 using pooled data for this post-hoc analysis. In terms of those who participated, a total of 864 patients were included (519 treated with nintedanib, 345 treated with placebo). Baseline characteristics including age, gender and FVC were similar between the subgroups of patients who had no decline or an improvement in FVC and those whose FVC declined, and between the nintedanib and placebo groups within each subgroup.
MedicalResearch.com: What are the main findings?
Response: The main findings showed that nintedanib -treated patients were twice as likely as those given placebo to experience an improvement or no decline in lung function, as measured by FVC, at week 52 (36.8%, nintedanib vs. 18.0%, placebo).
MedicalResearch.com: What should readers take away from your report?
Response: Although IPF is a progressive and unpredictable disease, these data highlight that for up to 52 weeks of treatment with nintedanib, those taking the treatment were twice as likely to have improved or stable lung function. This is an important step in exploring the way fibrosis of the lungs is treated and offers further insights into nintedanib’s effect on lung function; however, long term follow up is needed for additional support of these data.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: Continued research is key to continuing to understand fibrosing lung disease like IPF and advance patient care in this disease space. Specifically, further research is needed to determine if some patients with IPF can experience improvement in lung function and if so, how we can identify those individuals. Through this ongoing research, we can provide valuable insights and offer people with IPF and their pulmonologists additional evidence to support their treatment decisions.
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The abstract presented at ATS can be found in the link here: http://www.atsjournals.org/doi/abs/10.1164/ajrccm-conference.2017.195.1_MeetingAbstracts.A5399
Industry-related disclosures are listed here: Research funding to institution: Roche/Genentech, Afferent, BI Consultation related to IPF: BI, Roche/Genentech, ImmuneWorks, Fibrogen, Veracyte, Aeolus, Pharmakea, Sanofi-Genzyme
 Flaherty, K., Molb, M., Vancheri, C., et al. American Journal of Respiratory and Critical Care Medicine 2017;195:A5399. Improvement in Forced Vital Capacity (FVC) with Nintedanib in Patients with Idiopathic Pulmonary Fibrosis (IPF): Results from The INPULSIS Trials. http://www.atsjournals.org/doi/abs/10.1164/ajrccm-conference.2017.195.1_MeetingAbstracts.A5399. Accessed June 6, 2017.
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