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Effects of nintedanib by inclusion criteria for progression of interstitial lung disease

BACKGROUND: The INBUILD trial investigated nintedanib versus placebo in patients with progressive fibrosing interstitial lung diseases (ILDs). We investigated the decline in forced vital capacity (FVC) in subgroups based on the inclusion criteria for ILD progression. METHODS: Subjects had a fibrosin...

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Autores principales: Maher, Toby M., Brown, Kevin K., Kreuter, Michael, Devaraj, Anand, Walsh, Simon L.F., Lancaster, Lisa H., Belloli, Elizabeth A., Padilla, Maria, Behr, Juergen, Goeldner, Rainer-Georg, Tetzlaff, Kay, Schlenker-Herceg, Rozsa, Flaherty, Kevin R.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: European Respiratory Society 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8812469/
https://www.ncbi.nlm.nih.gov/pubmed/34210788
http://dx.doi.org/10.1183/13993003.04587-2020
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author Maher, Toby M.
Brown, Kevin K.
Kreuter, Michael
Devaraj, Anand
Walsh, Simon L.F.
Lancaster, Lisa H.
Belloli, Elizabeth A.
Padilla, Maria
Behr, Juergen
Goeldner, Rainer-Georg
Tetzlaff, Kay
Schlenker-Herceg, Rozsa
Flaherty, Kevin R.
author_facet Maher, Toby M.
Brown, Kevin K.
Kreuter, Michael
Devaraj, Anand
Walsh, Simon L.F.
Lancaster, Lisa H.
Belloli, Elizabeth A.
Padilla, Maria
Behr, Juergen
Goeldner, Rainer-Georg
Tetzlaff, Kay
Schlenker-Herceg, Rozsa
Flaherty, Kevin R.
author_sort Maher, Toby M.
collection PubMed
description BACKGROUND: The INBUILD trial investigated nintedanib versus placebo in patients with progressive fibrosing interstitial lung diseases (ILDs). We investigated the decline in forced vital capacity (FVC) in subgroups based on the inclusion criteria for ILD progression. METHODS: Subjects had a fibrosing ILD other than idiopathic pulmonary fibrosis and met the following criteria for ILD progression within the 24 months before screening despite management deemed appropriate in clinical practice: Group A, relative decline in FVC ≥10% predicted; Group B, relative decline in FVC ≥5–<10% predicted with worsened respiratory symptoms and/or increased extent of fibrosis on high-resolution computed tomography (HRCT); Group C, worsened respiratory symptoms and increased extent of fibrosis on HRCT only. RESULTS: In the placebo group, the rates of FVC decline over 52 weeks in Groups A, B and C, respectively, were −241.9, −133.1 and −115.3 mL per year in the overall population (p=0.0002 for subgroup-by-time interaction) and −288.9, −156.2 and −100.1 mL per year among subjects with a usual interstitial pneumonia (UIP)-like fibrotic pattern on HRCT (p=0.0005 for subgroup-by-time interaction). Nintedanib had a greater absolute effect on reducing the rate of FVC decline in Group A than in Group B or C. However, the relative effect of nintedanib versus placebo was consistent across the subgroups (p>0.05 for heterogeneity). CONCLUSIONS: The inclusion criteria used in the INBUILD trial, based on FVC decline or worsening of symptoms and extent of fibrosis on HRCT, were effective at identifying patients with progressive fibrosing ILDs. Nintedanib reduced the rate of decline in FVC across the subgroups based on the inclusion criteria related to ILD progression.
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spelling pubmed-88124692022-02-04 Effects of nintedanib by inclusion criteria for progression of interstitial lung disease Maher, Toby M. Brown, Kevin K. Kreuter, Michael Devaraj, Anand Walsh, Simon L.F. Lancaster, Lisa H. Belloli, Elizabeth A. Padilla, Maria Behr, Juergen Goeldner, Rainer-Georg Tetzlaff, Kay Schlenker-Herceg, Rozsa Flaherty, Kevin R. Eur Respir J Original Research Articles BACKGROUND: The INBUILD trial investigated nintedanib versus placebo in patients with progressive fibrosing interstitial lung diseases (ILDs). We investigated the decline in forced vital capacity (FVC) in subgroups based on the inclusion criteria for ILD progression. METHODS: Subjects had a fibrosing ILD other than idiopathic pulmonary fibrosis and met the following criteria for ILD progression within the 24 months before screening despite management deemed appropriate in clinical practice: Group A, relative decline in FVC ≥10% predicted; Group B, relative decline in FVC ≥5–<10% predicted with worsened respiratory symptoms and/or increased extent of fibrosis on high-resolution computed tomography (HRCT); Group C, worsened respiratory symptoms and increased extent of fibrosis on HRCT only. RESULTS: In the placebo group, the rates of FVC decline over 52 weeks in Groups A, B and C, respectively, were −241.9, −133.1 and −115.3 mL per year in the overall population (p=0.0002 for subgroup-by-time interaction) and −288.9, −156.2 and −100.1 mL per year among subjects with a usual interstitial pneumonia (UIP)-like fibrotic pattern on HRCT (p=0.0005 for subgroup-by-time interaction). Nintedanib had a greater absolute effect on reducing the rate of FVC decline in Group A than in Group B or C. However, the relative effect of nintedanib versus placebo was consistent across the subgroups (p>0.05 for heterogeneity). CONCLUSIONS: The inclusion criteria used in the INBUILD trial, based on FVC decline or worsening of symptoms and extent of fibrosis on HRCT, were effective at identifying patients with progressive fibrosing ILDs. Nintedanib reduced the rate of decline in FVC across the subgroups based on the inclusion criteria related to ILD progression. European Respiratory Society 2022-02-03 /pmc/articles/PMC8812469/ /pubmed/34210788 http://dx.doi.org/10.1183/13993003.04587-2020 Text en Copyright ©The authors 2022. https://creativecommons.org/licenses/by-nc/4.0/This version is distributed under the terms of the Creative Commons Attribution Non-Commercial Licence 4.0. For commercial reproduction rights and permissions contact permissions@ersnet.org (mailto:permissions@ersnet.org)
spellingShingle Original Research Articles
Maher, Toby M.
Brown, Kevin K.
Kreuter, Michael
Devaraj, Anand
Walsh, Simon L.F.
Lancaster, Lisa H.
Belloli, Elizabeth A.
Padilla, Maria
Behr, Juergen
Goeldner, Rainer-Georg
Tetzlaff, Kay
Schlenker-Herceg, Rozsa
Flaherty, Kevin R.
Effects of nintedanib by inclusion criteria for progression of interstitial lung disease
title Effects of nintedanib by inclusion criteria for progression of interstitial lung disease
title_full Effects of nintedanib by inclusion criteria for progression of interstitial lung disease
title_fullStr Effects of nintedanib by inclusion criteria for progression of interstitial lung disease
title_full_unstemmed Effects of nintedanib by inclusion criteria for progression of interstitial lung disease
title_short Effects of nintedanib by inclusion criteria for progression of interstitial lung disease
title_sort effects of nintedanib by inclusion criteria for progression of interstitial lung disease
topic Original Research Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8812469/
https://www.ncbi.nlm.nih.gov/pubmed/34210788
http://dx.doi.org/10.1183/13993003.04587-2020
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