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Acute exacerbations in the INPULSIS trials of nintedanib in idiopathic pulmonary fibrosis

Acute exacerbations in the INPULSIS trials of nintedanib in idiopathic pulmonary fibrosis
Acute exacerbations in the INPULSIS trials of nintedanib in idiopathic pulmonary fibrosis

Time to first investigator-reported acute exacerbation was a key secondary end-point in the INPULSIS trials of nintedanib in patients with idiopathic pulmonary fibrosis (IPF).We used the INPULSIS trial data to investigate risk factors for acute exacerbation of IPF and to explore the impact of nintedanib on risk and outcome of investigator-reported and adjudicated confirmed/suspected acute exacerbations. Mortality following these events and events adjudicated as not acute exacerbations was analysed using the log rank test.Risk of acute exacerbations was most strongly associated with the following variables: baseline forced vital capacity (higher risk with lower value), baseline supplemental oxygen (higher risk with use), baseline antacid medication (higher risk with use), treatment (higher risk with placebo), and for confirmed/suspected acute exacerbations, cigarette smoking. Mortality was similar following investigator-reported and adjudicated confirmed/suspected acute exacerbations. Nintedanib had no significant effect on risk of mortality post-exacerbation.Investigator-reported acute exacerbations of IPF are associated with similar risk factors and outcomes as adjudicated confirmed/suspected acute exacerbations.

0903-1936
1-7
Collard, Harold R.
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Richeldi, Luca
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Kim, Dong Soon
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Taniguchi, Hiroyuki
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Tschoepe, Inga
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Luisetti, Maurizio
ed08621d-5ac0-451c-b460-ddb0c1483a54
Roman, Jesse
cd3a52a0-ff0c-4a2c-8d16-346388b4e274
Tino, Gregory
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Schlenker-Herceg, Rozsa
b99d9236-8d93-43d8-8111-fa21b1f31e0b
Hallmann, Christoph
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du Bois, Roland M.
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Collard, Harold R.
6eee2ce5-3016-4c13-ac58-f30a77f7d141
Richeldi, Luca
47177d9c-731a-49a1-9cc6-4ac8f6bbbf26
Kim, Dong Soon
fc63af4d-dfe9-4131-9410-989dbc21a53e
Taniguchi, Hiroyuki
2ccfac1c-e5a4-4ac9-9683-1825867f1a1d
Tschoepe, Inga
49fc52a3-e89e-4739-ac92-7ebdea984cac
Luisetti, Maurizio
ed08621d-5ac0-451c-b460-ddb0c1483a54
Roman, Jesse
cd3a52a0-ff0c-4a2c-8d16-346388b4e274
Tino, Gregory
b8dab277-567a-4c3a-be20-52b49bfdaa1c
Schlenker-Herceg, Rozsa
b99d9236-8d93-43d8-8111-fa21b1f31e0b
Hallmann, Christoph
4fc31311-5d38-4b0a-80e3-01df6e1a96f4
du Bois, Roland M.
5f8aef36-d70e-4902-aded-f6da129c0741

Collard, Harold R., Richeldi, Luca, Kim, Dong Soon, Taniguchi, Hiroyuki, Tschoepe, Inga, Luisetti, Maurizio, Roman, Jesse, Tino, Gregory, Schlenker-Herceg, Rozsa, Hallmann, Christoph and du Bois, Roland M. (2017) Acute exacerbations in the INPULSIS trials of nintedanib in idiopathic pulmonary fibrosis. The European respiratory journal, 49 (5), 1-7, [1601339]. (doi:10.1183/13993003.01339-2016).

Record type: Article

Abstract

Time to first investigator-reported acute exacerbation was a key secondary end-point in the INPULSIS trials of nintedanib in patients with idiopathic pulmonary fibrosis (IPF).We used the INPULSIS trial data to investigate risk factors for acute exacerbation of IPF and to explore the impact of nintedanib on risk and outcome of investigator-reported and adjudicated confirmed/suspected acute exacerbations. Mortality following these events and events adjudicated as not acute exacerbations was analysed using the log rank test.Risk of acute exacerbations was most strongly associated with the following variables: baseline forced vital capacity (higher risk with lower value), baseline supplemental oxygen (higher risk with use), baseline antacid medication (higher risk with use), treatment (higher risk with placebo), and for confirmed/suspected acute exacerbations, cigarette smoking. Mortality was similar following investigator-reported and adjudicated confirmed/suspected acute exacerbations. Nintedanib had no significant effect on risk of mortality post-exacerbation.Investigator-reported acute exacerbations of IPF are associated with similar risk factors and outcomes as adjudicated confirmed/suspected acute exacerbations.

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Accepted/In Press date: 9 February 2017
Published date: 1 May 2017

Identifiers

Local EPrints ID: 443483
URI: http://eprints.soton.ac.uk/id/eprint/443483
ISSN: 0903-1936
PURE UUID: 9ffc3a8b-320f-4a0e-8d5d-c9f22cfe05b4

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Date deposited: 26 Aug 2020 16:36
Last modified: 07 Oct 2020 00:10

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Contributors

Author: Harold R. Collard
Author: Luca Richeldi
Author: Dong Soon Kim
Author: Hiroyuki Taniguchi
Author: Inga Tschoepe
Author: Maurizio Luisetti
Author: Jesse Roman
Author: Gregory Tino
Author: Rozsa Schlenker-Herceg
Author: Christoph Hallmann
Author: Roland M. du Bois

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