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Efficacy of nintedanib in idiopathic pulmonary fibrosis across prespecified subgroups in INPULSIS

Efficacy of nintedanib in idiopathic pulmonary fibrosis across prespecified subgroups in INPULSIS
Efficacy of nintedanib in idiopathic pulmonary fibrosis across prespecified subgroups in INPULSIS

Rationale: In the two replicate, placebo-controlled, 52-week, phase III INPULSIS trials, nintedanib 150 mg twice daily significantly reduced the annual rate of decline in FVC, the primary endpoint, in subjects with idiopathic pulmonary fibrosis (IPF). It is unknown if this effect was uniform across all subjects treated with nintedanib. Objectives: To investigate the potential association of demographic and clinical variables with the effect of nintedanib in subjects with IPF. Methods: Subgroup analyses of pooled data from the INPULSIS trials were prespecified. Subgroups were analyzed by sex, age (<65, ≥ 65 yr), race (white, Asian), baseline FVC percentage predicted (≥ 70%, >70%), baseline St. George's Respiratory Questionnaire (SGRQ) total score (≤ 40, >40), smoking status (never, ex/current), systemic corticosteroid use (yes/no), and bronchodilator use (yes/no). Measurements and Main Results: A total of 1,061 subjects were treated (nintedanib n = 638, placebo n = 423). There was no statistically significant difference in the effect of nintedanib for the primary endpoint or the key secondary endpoints of change from baseline in SGRQ total score or time to first acute exacerbation in any subgroup. Treatment effects for the key secondary endpoints seemed more pronounced in subjects with baseline FVC ≤ 70% predicted, because the majority of acute exacerbations and a greater deterioration in SGRQ total score occurred in placebo-treated subjects in this subgroup. Conclusions: Pooled data from the INPULSIS trials support a consistent effect of nintedanib across a range of IPF phenotypes by slowing disease progression across a number of prespecified subgroups.

Disease progression, Forced vital capacity, Quality of life
1073-449X
178-185
Costabel, Ulrich
4dc38723-49b2-4f71-aeee-6b959553c3b8
Inoue, Yoshikazu
deae4955-7f69-4fc2-a611-7f3fc07d09c4
Richeldi, Luca
47177d9c-731a-49a1-9cc6-4ac8f6bbbf26
Collard, Harold R.
6eee2ce5-3016-4c13-ac58-f30a77f7d141
Tschoepe, Inga
49fc52a3-e89e-4739-ac92-7ebdea984cac
Stowasser, Susanne
db03e3f9-5df8-403d-b6f7-5284a506fd94
Azuma, Arata
f6ca02ae-75d2-4414-b4dd-ef74306a3e93
Costabel, Ulrich
4dc38723-49b2-4f71-aeee-6b959553c3b8
Inoue, Yoshikazu
deae4955-7f69-4fc2-a611-7f3fc07d09c4
Richeldi, Luca
47177d9c-731a-49a1-9cc6-4ac8f6bbbf26
Collard, Harold R.
6eee2ce5-3016-4c13-ac58-f30a77f7d141
Tschoepe, Inga
49fc52a3-e89e-4739-ac92-7ebdea984cac
Stowasser, Susanne
db03e3f9-5df8-403d-b6f7-5284a506fd94
Azuma, Arata
f6ca02ae-75d2-4414-b4dd-ef74306a3e93

Costabel, Ulrich, Inoue, Yoshikazu, Richeldi, Luca, Collard, Harold R., Tschoepe, Inga, Stowasser, Susanne and Azuma, Arata (2016) Efficacy of nintedanib in idiopathic pulmonary fibrosis across prespecified subgroups in INPULSIS. American Journal of Respiratory and Critical Care Medicine, 193 (2), 178-185. (doi:10.1164/rccm.201503-0562OC).

Record type: Article

Abstract

Rationale: In the two replicate, placebo-controlled, 52-week, phase III INPULSIS trials, nintedanib 150 mg twice daily significantly reduced the annual rate of decline in FVC, the primary endpoint, in subjects with idiopathic pulmonary fibrosis (IPF). It is unknown if this effect was uniform across all subjects treated with nintedanib. Objectives: To investigate the potential association of demographic and clinical variables with the effect of nintedanib in subjects with IPF. Methods: Subgroup analyses of pooled data from the INPULSIS trials were prespecified. Subgroups were analyzed by sex, age (<65, ≥ 65 yr), race (white, Asian), baseline FVC percentage predicted (≥ 70%, >70%), baseline St. George's Respiratory Questionnaire (SGRQ) total score (≤ 40, >40), smoking status (never, ex/current), systemic corticosteroid use (yes/no), and bronchodilator use (yes/no). Measurements and Main Results: A total of 1,061 subjects were treated (nintedanib n = 638, placebo n = 423). There was no statistically significant difference in the effect of nintedanib for the primary endpoint or the key secondary endpoints of change from baseline in SGRQ total score or time to first acute exacerbation in any subgroup. Treatment effects for the key secondary endpoints seemed more pronounced in subjects with baseline FVC ≤ 70% predicted, because the majority of acute exacerbations and a greater deterioration in SGRQ total score occurred in placebo-treated subjects in this subgroup. Conclusions: Pooled data from the INPULSIS trials support a consistent effect of nintedanib across a range of IPF phenotypes by slowing disease progression across a number of prespecified subgroups.

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More information

Accepted/In Press date: 22 September 2015
Published date: 15 January 2016
Keywords: Disease progression, Forced vital capacity, Quality of life

Identifiers

Local EPrints ID: 443449
URI: http://eprints.soton.ac.uk/id/eprint/443449
ISSN: 1073-449X
PURE UUID: 83d60a60-85fc-4692-b2cb-fcb4a5a2d0bf

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Date deposited: 26 Aug 2020 16:34
Last modified: 16 Mar 2021 17:41

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