Extract
Disease progression in idiopathic pulmonary fibrosis (IPF) is monitored by decline in forced vital capacity (FVC) [1]. An absolute or relative decline in % predicted FVC ≥10% is associated with mortality [2, 3]. Measures of FVC decline were selected as primary endpoints in the pivotal phase 3 trials of antifibrotic therapies [4–6]. Despite consistent trends for FVC decline in the IPF population, the rate of disease progression in individuals is unpredictable and highly variable: significant variability in FVC is observed over time, and prior declines are a poor predictor of future FVC decline [1, 7, 8]. In new trials in IPF, the margin for reducing FVC decline is smaller (∼70 mL) in patients who are receiving an investigational drug with background antifibrotics than in the placebo arms of past trials (130–210 mL) [9].
Abstract
Variability in 3-month changes in FVC was examined in 954 patients with IPF (n=3966 observations) from phase 3 trials; concurrent 3-month decline in the FVC and 6MWD (n=1321 observations) predicted further decline in FVC over the subsequent 3 months http://bit.ly/2GfBKW3
Acknowledgements
We thank the patients who participated in the studies and their families. Support for third-party writing assistance, furnished by Benjamin Ricca of Health Interactions, Inc., was provided by F. Hoffmann-La Roche Ltd.
Footnotes
Qualified researchers may request access to individual patient–level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available at https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx Further details on Roche's Global Policy on the Sharing of Clinical Study Information and how to request access to related clinical study documents can be found at www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm
Conflict of interest: S.D. Nathan was a member of the ASCEND study steering committee; has served on a scientific advisory board and received research funding from InterMune (a wholly owned subsidiary of Roche); has received research funding and served as a consultant for Boehringer Ingelheim, Gilead and Roche/Genentech and is on the speakers bureau for Roche/Genentech and Boehringer Ingelheim; his institution has received research funding from Boehringer Ingelheim and Roche/Genentech.
Conflict of interest: M. Yang is an employee of Genentech, Inc.
Conflict of interest: E.A. Morgenthien is an employee of Genentech, Inc.
Conflict of interest: J.L. Stauffer is an employee of Genentech, Inc.
Support statement: F. Hoffmann-La Roche Ltd and Genentech, Inc. provided funding and support for this work. The GIPF-001 trial was originally sponsored by InterMune. ASCEND and CAPACITY were sponsored by F. Hoffmann-La Roche Ltd. Funding information for this article has been deposited with the Crossref Funder Registry.
- Received November 5, 2019.
- Accepted January 18, 2020.
- Copyright ©ERS 2020
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