Abstract
In the Phase III INPULSIS® trials, nintedanib reduced the annual rate of decline in forced vital capacity (FVC) versus placebo in patients with idiopathic pulmonary fibrosis (IPF).
We conducted post hoc analyses of the distribution of changes in FVC in the INPULSIS® trials and FVC changes in the open-label extension trial INPULSIS®-ON in subgroups of patients based on whether patients had shown an improvement or no decline in FVC in INPULSIS®. Analyses were descriptive.
Based on the annual rate of change in FVC, 158 of 638 patients (24.8%) treated with nintedanib and 38 of 423 patients (9.0%) treated with placebo had an improvement/no decline in FVC in the INPULSIS® trials. In patients whose FVC improved/did not decline, median (interquartile range) improvements in FVC at week 52 were 76.5 (31–152) mL and 57.5 (31–103) mL in the nintedanib and placebo groups, respectively. Changes in FVC from baseline to week 48 of INPULSIS®-ON were similar in patients whose FVC improved or declined in the preceding INPULSIS® trial.
In the INPULSIS® trials, treatment with nintedanib resulted in a greater proportion of patients with IPF showing an improvement/no decline in FVC compared to taking placebo. Mechanisms underlying improvement in FVC in patients with IPF are unknown.
Abstract
25% of nintedanib-treated and 9% of placebo-treated patients in INPULSIS had an improvement in FVC over 52 weeks http://ow.ly/P30b30knPe2
Footnotes
This article has supplementary material available from erj.ersjournals.com
Conflict of interest: K.R. Flaherty reports grants and personal fees for consultancy from Boehringer Ingelheim and Roche/Genentech; personal fees for consultancy from Veracyte, Biogen, Aeolus, Pharmakea, Fibrogen and Sanofi-Genzyme; and grants from Afferent; outside the submitted work.
Conflict of interest: M. Kolb reports grants from Canadian Pulmonary Fibrosis Foundation and Canadian Institute for Health Research; grants and personal fees for advisory board work from Pulmonary Fibrosis Foundation, Roche Canada and Janssen; personal fees for advisory board work from Boehringer Ingelheim, GlaxoSmithKline, AstraZeneca, Vertex, Genoa, Gilead, Prometic and Alkermes; and has been site principal investigator in industry-sponsored clinical trials for Roche, Sanofi and Boehringer Ingelheim; outside the submitted work.
Conflict of interest: C. Vancheri reports grants and personal fees from Roche and Boehringer Ingelheim, outside the submitted work.
Conflict of interest: W. Tang is an employee of Boehringer Ingelheim Pharmaceuticals, Inc.
Conflict of interest: C.S. Conoscenti is an employee of Boehringer Ingelheim Pharmaceuticals, Inc.
Conflict of interest: L. Richeldi reports grants and personal fees for advisory board work from InterMune; personal fees for advisory board work from Medimmune, Roche and Takeda; personal fees for consultancy from Biogen-Idec, Sanofi-Aventis and ImmuneWorks; personal fees for lecturing from Shionogi; personal fees for steering committee work from Boehringer Ingelheim; and personal fees from Pliant Therapeutics; outside the submitted work.
Support statement: The INPULSIS® and INPULSIS®-ON trials were funded by Boehringer Ingelheim Pharmaceuticals, Inc. Funding information for this article has been deposited with the Crossref Funder Registry.
- Received December 13, 2017.
- Accepted May 30, 2018.
- Copyright ©ERS 2018
INDIVIDUALS
Log in using your username and password
LIBRARY USERS
Log in through your institution
Purchase access
CONTACT US
If you have any questions about the ERS publications website, please contact journals@ersnet.org
