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Nintedanib in patients with idiopathic pulmonary fibrosis and preserved lung volume

Nintedanib in patients with idiopathic pulmonary fibrosis and preserved lung volume
Nintedanib in patients with idiopathic pulmonary fibrosis and preserved lung volume

Rationale There is no consensus as to when treatment for idiopathic pulmonary fibrosis (IPF) should be initiated. Some physicians prefer not to treat patients with preserved lung volume. Objective To investigate whether patients with IPF and preserved lung volume receive the same benefit from nintedanib as patients with more impaired lung volume. Methods Post hoc subgroup analyses of pooled data from the two replicate phase III INPULSIS trials by baseline FVC % predicted (≤90%, >90%). Results At baseline, 274 patients had FVC >90% predicted and 787 patients had FVC ≤90% predicted. In patients treated with placebo, the adjusted annual rate of decline in FVC was consistent between patients with FVC >90% predicted and FVC ≤90% predicted (â '224.6â €..mL/year and â '223.6â €..mL/year, respectively). There was no statistically significant difference between these subgroups in the effect of nintedanib on annual rate of decline in FVC, change from baseline in St George's Respiratory Questionnaire total score or time to first acute exacerbation. In patients with baseline FVC >90% predicted and ≤90% predicted, respectively, the adjusted annual rate of decline in FVC with nintedanib was â '91.5â €..mL/year (difference vs placebo: 133.1â €..mL/year (95% CI 68.0 to 198.2)) and â '121.5â €..mL/year (difference vs placebo: 102.1â €..mL/year (95% CI 61.9 to 142.3)). Adverse events associated with nintedanib were similar in both subgroups. Conclusions Patients with IPF and preserved lung volume (FVC >90% predicted) have the same rate of FVC decline and receive the same benefit from nintedanib as patients with more impaired lung volume. Trial registration number NCT01335464 and NCT01335477.

Idiopathic pulmonary fibrosis
0040-6376
340-346
Kolb, Martin
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Richeldi, Luca
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Behr, Jürgen
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Maher, Toby M.
6c166764-7a4e-4d20-b528-381a7218ea0b
Tang, Wenbo
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Stowasser, Susanne
db03e3f9-5df8-403d-b6f7-5284a506fd94
Hallmann, Christoph
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Du Bois, Roland M.
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Kolb, Martin
f7169cba-735d-4c03-b348-55f170d1b5dd
Richeldi, Luca
47177d9c-731a-49a1-9cc6-4ac8f6bbbf26
Behr, Jürgen
c87301f1-90b1-4ca0-8ea8-e83566e18431
Maher, Toby M.
6c166764-7a4e-4d20-b528-381a7218ea0b
Tang, Wenbo
6ca86272-275d-4d01-b22d-71fbe3e1f73e
Stowasser, Susanne
db03e3f9-5df8-403d-b6f7-5284a506fd94
Hallmann, Christoph
4fc31311-5d38-4b0a-80e3-01df6e1a96f4
Du Bois, Roland M.
5f8aef36-d70e-4902-aded-f6da129c0741

Kolb, Martin, Richeldi, Luca, Behr, Jürgen, Maher, Toby M., Tang, Wenbo, Stowasser, Susanne, Hallmann, Christoph and Du Bois, Roland M. (2017) Nintedanib in patients with idiopathic pulmonary fibrosis and preserved lung volume. Thorax, 72 (4), 340-346. (doi:10.1136/thoraxjnl-2016-208710).

Record type: Article

Abstract

Rationale There is no consensus as to when treatment for idiopathic pulmonary fibrosis (IPF) should be initiated. Some physicians prefer not to treat patients with preserved lung volume. Objective To investigate whether patients with IPF and preserved lung volume receive the same benefit from nintedanib as patients with more impaired lung volume. Methods Post hoc subgroup analyses of pooled data from the two replicate phase III INPULSIS trials by baseline FVC % predicted (≤90%, >90%). Results At baseline, 274 patients had FVC >90% predicted and 787 patients had FVC ≤90% predicted. In patients treated with placebo, the adjusted annual rate of decline in FVC was consistent between patients with FVC >90% predicted and FVC ≤90% predicted (â '224.6â €..mL/year and â '223.6â €..mL/year, respectively). There was no statistically significant difference between these subgroups in the effect of nintedanib on annual rate of decline in FVC, change from baseline in St George's Respiratory Questionnaire total score or time to first acute exacerbation. In patients with baseline FVC >90% predicted and ≤90% predicted, respectively, the adjusted annual rate of decline in FVC with nintedanib was â '91.5â €..mL/year (difference vs placebo: 133.1â €..mL/year (95% CI 68.0 to 198.2)) and â '121.5â €..mL/year (difference vs placebo: 102.1â €..mL/year (95% CI 61.9 to 142.3)). Adverse events associated with nintedanib were similar in both subgroups. Conclusions Patients with IPF and preserved lung volume (FVC >90% predicted) have the same rate of FVC decline and receive the same benefit from nintedanib as patients with more impaired lung volume. Trial registration number NCT01335464 and NCT01335477.

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Accepted/In Press date: 27 August 2016
e-pub ahead of print date: 26 September 2016
Published date: 1 April 2017
Keywords: Idiopathic pulmonary fibrosis

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Local EPrints ID: 443358
URI: http://eprints.soton.ac.uk/id/eprint/443358
ISSN: 0040-6376
PURE UUID: 029984f8-9d1a-4de0-a176-e6d444e80ec1

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Date deposited: 21 Aug 2020 16:30
Last modified: 16 Mar 2021 17:41

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Contributors

Author: Martin Kolb
Author: Luca Richeldi
Author: Jürgen Behr
Author: Toby M. Maher
Author: Wenbo Tang
Author: Susanne Stowasser
Author: Christoph Hallmann
Author: Roland M. Du Bois

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