Nintedanib (OFEV®) May Offer Survival Advantage for IPF Patients

MedicalResearch.com Interview with:

Christopher J. Ryerson, M.D. Assistant Professor Centre for Heart Lung Innovation University of British Columbia Vancouver, Canada

Dr. Ryerson

Christopher J. Ryerson, M.D.
Assistant Professor
Centre for Heart Lung Innovation
University of British Columbia
Vancouver, Canada

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: A new Idiopathic pulmonary fibrosis (IPF) mortality analysis presented at the American Thoracic Society’s 2018 annual conference suggests that treatment with nintedanib may be associated with reduced risk of death in patients with the rare lung disease idiopathic pulmonary fibrosis (IPF).

Pooled data from the two Phase II INPULSIS trials and the Phase II TOMORROW study compared the number of deaths observed versus the number predicted based on GAP stage over one year. GAP stage is used to predict IPF prognosis and is based on gender, age and lung function (as measured by forced vital capacity [FVC] decline predicted and DLco % predicted). Higher stages of GAP are associated with an increased risk of death.

Across the population in the analysis (n=1,228), there were fewer deaths observed in each treatment group than predicted based on GAP stage at baseline (nintedanib: 42 vs. 89.9; placebo: 41 vs. 64.2). In the treated group, the number of observed deaths was 46.7% of the number predicted based on GAP stage, while in the placebo group the number of observed deaths was 63.9% of the number predicted. Based on these observations, the analysis suggests that nintedanib may be associated with a 26.8% relative reduction in the risk of death compared with placebo over one year. 

MedicalResearch.com: What should readers take away from your report?

Response: Although the individual trials included in this analysis were not powered to measure mortality, our pooled analysis suggests that nintedanib may offer a survival benefit for IPF patients. As Idiopathic pulmonary fibrosis is a progressive and fatal disease, this is an important finding that supports the established efficacy of nintedanib observed in clinical trials. 

MedicalResearch.com: What recommendations do you have for future research as a result of this study?

Response: Continued research will be key to continuing to understand interstitial lung diseases like Idiopathic pulmonary fibrosis and advance patient care for those living with this disease. While these data show that nintedanib can slow disease progression by reducing the rate of lung function decline, additional controlled studies are valuable to further providing insights and offering people with Idiopathic pulmonary fibrosis and their pulmonologists evidence to support their treatment decisions.

MedicalResearch.com: Is there anything else you would like to add? Any disclosures?

ResponseIdiopathic pulmonary fibrosis is a progressive and fatal disease, and it’s important that the research community continues to study available treatments for further insights into how they may benefit people living with this rare disease.

The TOMORROW and INPULSIS trials were funded by Boehringer Ingelheim.

Citation:

American Journal of Respiratory and Critical Care Medicine 2018;197:A2534
Predicted Versus Observed Mortality in Clinical Trials of Nintedanib in Idiopathic Pulmonary Fibrosis (IPF)

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