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Effect of nintedanib in subgroups of idiopathic pulmonary fibrosis by diagnostic criteria

Effect of nintedanib in subgroups of idiopathic pulmonary fibrosis by diagnostic criteria
Effect of nintedanib in subgroups of idiopathic pulmonary fibrosis by diagnostic criteria

Rationale: In the absence of a surgical lung biopsy, patients diagnosed with idiopathic pulmonary fibrosis (IPF) in clinical practice could participate in the INPULSIS trials of nintedanib if they had honeycombing and/or traction bronchiectasis plus reticulation, without atypical features of usual interstitial pneumonia (UIP), on high-resolution computed tomography (HRCT). Thus, the patients in these trials represented patients with definite UIP and a large subgroup of patients with possible UIP.

Objectives: To investigate the potential impact of diagnostic subgroups on the progression of IPF and the effect of nintedanib.

Methods: We conducted a post hoc subgroup analysis of patients with honeycombing on HRCT and/or confirmation of UIP by biopsy versus patients without either, using pooled data from the INPULSIS trials.

Measurements and Main Results: Seven hundred twenty-three (68.1%) patients had honeycombing and/or biopsy, and 338 (31.9%) patients had no honeycombing or biopsy. In these subgroups, respectively, the adjusted annual rate of decline in FVC in patients treated with placebo was 2225.7 and 2221.0 ml/yr, and the nintedanib versus placebo difference in the adjusted annual rate of declineinFVCwas117.0ml/yr(95%confidenceinterval,76.3-157.8) and 98.9 ml/yr (95% confidence interval, 36.4-161.5). There was no significant treatment-by-subgroup interaction (P = 0.8139). Adverse events were similar between the subgroups.

Conclusions: Patients with IPF diagnosed in clinical practice who had possible UIP with traction bronchiectasis on HRCT and had not undergonesurgicallungbiopsyhaddiseasethatprogressedinasimilar way, and responded similarly to nintedanib, to that of patients with honeycombing on HRCT and/or confirmation of UIP by biopsy.

Diagnosis, High-resolution computed tomography, Honeycombing, HRCT, Traction bronchiectasis
1073-449X
78-85
Raghu, Ganesh
bf5d4a84-1eae-4e42-aac8-5fb9fb49d2ab
Wells, Athol U.
47bba0f1-7cf9-4e3d-97b3-2be719a87357
Nicholson, Andrew G.
96615ec5-6082-4999-b383-fca53d2f991b
Richeldi, Luca
47177d9c-731a-49a1-9cc6-4ac8f6bbbf26
Flaherty, Kevin R.
9d1edc7b-124b-43b3-8d54-85f7b54b67ee
Maulf, Florence Le
c1cc2912-bf9a-4dfa-94ce-7c1d6b8a56c4
Stowasser, Susanne
db03e3f9-5df8-403d-b6f7-5284a506fd94
Schlenker-Herceg, Rozsa
b99d9236-8d93-43d8-8111-fa21b1f31e0b
Hansell, David M.
6ffd4a69-9a48-4062-b0ca-c509faedede7
Raghu, Ganesh
bf5d4a84-1eae-4e42-aac8-5fb9fb49d2ab
Wells, Athol U.
47bba0f1-7cf9-4e3d-97b3-2be719a87357
Nicholson, Andrew G.
96615ec5-6082-4999-b383-fca53d2f991b
Richeldi, Luca
47177d9c-731a-49a1-9cc6-4ac8f6bbbf26
Flaherty, Kevin R.
9d1edc7b-124b-43b3-8d54-85f7b54b67ee
Maulf, Florence Le
c1cc2912-bf9a-4dfa-94ce-7c1d6b8a56c4
Stowasser, Susanne
db03e3f9-5df8-403d-b6f7-5284a506fd94
Schlenker-Herceg, Rozsa
b99d9236-8d93-43d8-8111-fa21b1f31e0b
Hansell, David M.
6ffd4a69-9a48-4062-b0ca-c509faedede7

Raghu, Ganesh, Wells, Athol U., Nicholson, Andrew G., Richeldi, Luca, Flaherty, Kevin R., Maulf, Florence Le, Stowasser, Susanne, Schlenker-Herceg, Rozsa and Hansell, David M. (2017) Effect of nintedanib in subgroups of idiopathic pulmonary fibrosis by diagnostic criteria. American Journal of Respiratory and Critical Care Medicine, 195 (1), 78-85. (doi:10.1164/rccm.201602-0402OC).

Record type: Article

Abstract

Rationale: In the absence of a surgical lung biopsy, patients diagnosed with idiopathic pulmonary fibrosis (IPF) in clinical practice could participate in the INPULSIS trials of nintedanib if they had honeycombing and/or traction bronchiectasis plus reticulation, without atypical features of usual interstitial pneumonia (UIP), on high-resolution computed tomography (HRCT). Thus, the patients in these trials represented patients with definite UIP and a large subgroup of patients with possible UIP.

Objectives: To investigate the potential impact of diagnostic subgroups on the progression of IPF and the effect of nintedanib.

Methods: We conducted a post hoc subgroup analysis of patients with honeycombing on HRCT and/or confirmation of UIP by biopsy versus patients without either, using pooled data from the INPULSIS trials.

Measurements and Main Results: Seven hundred twenty-three (68.1%) patients had honeycombing and/or biopsy, and 338 (31.9%) patients had no honeycombing or biopsy. In these subgroups, respectively, the adjusted annual rate of decline in FVC in patients treated with placebo was 2225.7 and 2221.0 ml/yr, and the nintedanib versus placebo difference in the adjusted annual rate of declineinFVCwas117.0ml/yr(95%confidenceinterval,76.3-157.8) and 98.9 ml/yr (95% confidence interval, 36.4-161.5). There was no significant treatment-by-subgroup interaction (P = 0.8139). Adverse events were similar between the subgroups.

Conclusions: Patients with IPF diagnosed in clinical practice who had possible UIP with traction bronchiectasis on HRCT and had not undergonesurgicallungbiopsyhaddiseasethatprogressedinasimilar way, and responded similarly to nintedanib, to that of patients with honeycombing on HRCT and/or confirmation of UIP by biopsy.

Full text not available from this repository.

More information

Accepted/In Press date: 9 June 2016
e-pub ahead of print date: 22 June 2016
Published date: 1 January 2017
Keywords: Diagnosis, High-resolution computed tomography, Honeycombing, HRCT, Traction bronchiectasis

Identifiers

Local EPrints ID: 443357
URI: http://eprints.soton.ac.uk/id/eprint/443357
ISSN: 1073-449X
PURE UUID: 48c1f8fa-4c68-4295-bb6e-32aa4a0e2613

Catalogue record

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

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