20 Jul Nintedanib – Ofev – Slows Progression in Broader Group of Idiopathic Pulmonary Fibrosis Patients
MedicalResearch.com Interview with:
Ganesh Raghu, M.D. FACP, FCCP
Professor of Medicine
Division of Pulmonary and Critical Care Medicine and Director of Center for Interstitial Lung Diseases
Director, Interstitial Lung Disease/Sarcoid/Pulmonary Fibrosis Program
University of Washington Medical Center
MedicalResearch.com: What is the background for this study?
Response: This is a new post-hoc analysis of the Phase III INPULSIS trials, including a total of 1,061 patients with idiopathic pulmonary fibrosis (IPF), which has been published in the American Journal of Respiratory and Critical Care Medicine.
As background, achieving an accurate diagnosis of IPF in clinical practice is very complex and challenging. Physicians use an imaging technique called high resolution computed tomography (HRCT) to help them identify the presence of scarring (fibrosis) and, specifically, the presence of usual interstitial pneumonia (UIP) pattern in the lungs. The radiological changes called “honeycombing” are the key feature of the UIP pattern visible on HRCT and the pattern of UIP is the hallmark of the fibrosis in patients with IPF. In the absence of definitive UIP pattern on HRCT images of the lungs, the diagnosis of idiopathic pulmonary fibrosis requires the microscopic features of UIP in the surgical lung biopsy (SLB) based on current guidelines for diagnosis of IPF.
However, it can be challenging to confirm that scarring in the absence of honeycombing on HRCT meets the strict guideline criteria for a definitive diagnosis of IPF. For a large group of patients who do not receive a confirmed diagnosis of IPF according to guidelines, including those not eligible for surgical lung biopsy, the clinical course of their condition and the effectiveness of idiopathic pulmonary fibrosis treatment remains unknown. Therefore, investigations into the behavior of the disease across diagnostic subgroups are important.
MedicalResearch.com: What are the main findings?
Response: This post-hoc analysis shows, for the first time, that disease progression is similar in idiopathic pulmonary fibrosis patients enrolled in the clinical trials (INPULSIS) using a broader diagnostic definition compared with the current diagnostic guideline. The analysis also shows that Ofev (nintedanib) is effective in slowing disease progression in the subgroups of patients with IPF with honeycombing and the patients who have pulmonary fibrosis without honeycombing studied in Phase III, and may be applicable to similar patients seen in clinical practice.
MedicalResearch.com: What should readers take away from your report?
Response: This analysis suggests that the disease course and response to treatment with nintedanib is similar in patients with IPF who meet the current criteria for diagnosis of IPF and those patients with pulmonary fibrosis of unknown cause who have similar clinical and radiographic features with the exception of honeycombing. This has implications in design of future clinical trials and considerations while updating 2011 criteria for diagnosis of IPF.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: I would recommend continuation of similar analyses and further research to ascertain the diagnosis of idiopathic pulmonary fibrosis and differentiate from other fibrotic lung diseases with similar clinical and radiological features. IPF is a devastating and serious condition affecting as many as 132,000 Americans, and is extremely complex to diagnose. With additional analyses, we are able to further glean insights and advance understanding as to how the disease progresses, as well as criteria for its diagnosis.
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Am J Respir Crit Care Med. First published online 22 Jun 2016 as DOI: 10.1164/rccm.201602-0402OC
Effect of Nintedanib in Subgroups of Idiopathic Pulmonary Fibrosis by Diagnostic Criteria
Ganesh Raghu, Athol U Wells, Andrew G Nicholson, Luca Richeldi, Kevin R Flaherty, Florence Le Maulf, Susanne Stowasser, Rozsa Schlenker-Herceg, and David M Hansell
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