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Effect of nintedanib in patients with progressive pulmonary fibrosis associated with rheumatoid arthritis: data from the INBUILD trial
OBJECTIVES: Some patients with rheumatoid arthritis develop interstitial lung disease (RA-ILD) that develops into progressive pulmonary fibrosis. We assessed the efficacy and safety of nintedanib versus placebo in patients with progressive RA-ILD in the INBUILD trial. METHODS: The INBUILD trial enro...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer International Publishing
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10412475/ https://www.ncbi.nlm.nih.gov/pubmed/37209188 http://dx.doi.org/10.1007/s10067-023-06623-7 |
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author | Matteson, Eric L. Aringer, Martin Burmester, Gerd R. Mueller, Heiko Moros, Lizette Kolb, Martin |
author_facet | Matteson, Eric L. Aringer, Martin Burmester, Gerd R. Mueller, Heiko Moros, Lizette Kolb, Martin |
author_sort | Matteson, Eric L. |
collection | PubMed |
description | OBJECTIVES: Some patients with rheumatoid arthritis develop interstitial lung disease (RA-ILD) that develops into progressive pulmonary fibrosis. We assessed the efficacy and safety of nintedanib versus placebo in patients with progressive RA-ILD in the INBUILD trial. METHODS: The INBUILD trial enrolled patients with fibrosing ILD (reticular abnormality with traction bronchiectasis, with or without honeycombing) on high-resolution computed tomography of >10% extent. Patients had shown progression of pulmonary fibrosis within the prior 24 months, despite management in clinical practice. Subjects were randomised to receive nintedanib or placebo. RESULTS: In the subgroup of 89 patients with RA-ILD, the rate of decline in FVC over 52 weeks was −82.6 mL/year in the nintedanib group versus −199.3 mL/year in the placebo group (difference 116.7 mL/year [95% CI 7.4, 226.1]; nominal p = 0.037). The most frequent adverse event was diarrhoea, which was reported in 61.9% and 27.7% of patients in the nintedanib and placebo groups, respectively, over the whole trial (median exposure: 17.4 months). Adverse events led to permanent discontinuation of trial drug in 23.8% and 17.0% of subjects in the nintedanib and placebo groups, respectively. CONCLUSIONS: In the INBUILD trial, nintedanib slowed the decline in FVC in patients with progressive fibrosing RA-ILD, with adverse events that were largely manageable. The efficacy and safety of nintedanib in these patients were consistent with the overall trial population. A graphical abstract is available at: https://www.globalmedcomms.com/respiratory/INBUILD_RA-ILD. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s10067-023-06623-7. |
format | Online Article Text |
id | pubmed-10412475 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Springer International Publishing |
record_format | MEDLINE/PubMed |
spelling | pubmed-104124752023-08-11 Effect of nintedanib in patients with progressive pulmonary fibrosis associated with rheumatoid arthritis: data from the INBUILD trial Matteson, Eric L. Aringer, Martin Burmester, Gerd R. Mueller, Heiko Moros, Lizette Kolb, Martin Clin Rheumatol Original Article OBJECTIVES: Some patients with rheumatoid arthritis develop interstitial lung disease (RA-ILD) that develops into progressive pulmonary fibrosis. We assessed the efficacy and safety of nintedanib versus placebo in patients with progressive RA-ILD in the INBUILD trial. METHODS: The INBUILD trial enrolled patients with fibrosing ILD (reticular abnormality with traction bronchiectasis, with or without honeycombing) on high-resolution computed tomography of >10% extent. Patients had shown progression of pulmonary fibrosis within the prior 24 months, despite management in clinical practice. Subjects were randomised to receive nintedanib or placebo. RESULTS: In the subgroup of 89 patients with RA-ILD, the rate of decline in FVC over 52 weeks was −82.6 mL/year in the nintedanib group versus −199.3 mL/year in the placebo group (difference 116.7 mL/year [95% CI 7.4, 226.1]; nominal p = 0.037). The most frequent adverse event was diarrhoea, which was reported in 61.9% and 27.7% of patients in the nintedanib and placebo groups, respectively, over the whole trial (median exposure: 17.4 months). Adverse events led to permanent discontinuation of trial drug in 23.8% and 17.0% of subjects in the nintedanib and placebo groups, respectively. CONCLUSIONS: In the INBUILD trial, nintedanib slowed the decline in FVC in patients with progressive fibrosing RA-ILD, with adverse events that were largely manageable. The efficacy and safety of nintedanib in these patients were consistent with the overall trial population. A graphical abstract is available at: https://www.globalmedcomms.com/respiratory/INBUILD_RA-ILD. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s10067-023-06623-7. Springer International Publishing 2023-05-20 2023 /pmc/articles/PMC10412475/ /pubmed/37209188 http://dx.doi.org/10.1007/s10067-023-06623-7 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . |
spellingShingle | Original Article Matteson, Eric L. Aringer, Martin Burmester, Gerd R. Mueller, Heiko Moros, Lizette Kolb, Martin Effect of nintedanib in patients with progressive pulmonary fibrosis associated with rheumatoid arthritis: data from the INBUILD trial |
title | Effect of nintedanib in patients with progressive pulmonary fibrosis associated with rheumatoid arthritis: data from the INBUILD trial |
title_full | Effect of nintedanib in patients with progressive pulmonary fibrosis associated with rheumatoid arthritis: data from the INBUILD trial |
title_fullStr | Effect of nintedanib in patients with progressive pulmonary fibrosis associated with rheumatoid arthritis: data from the INBUILD trial |
title_full_unstemmed | Effect of nintedanib in patients with progressive pulmonary fibrosis associated with rheumatoid arthritis: data from the INBUILD trial |
title_short | Effect of nintedanib in patients with progressive pulmonary fibrosis associated with rheumatoid arthritis: data from the INBUILD trial |
title_sort | effect of nintedanib in patients with progressive pulmonary fibrosis associated with rheumatoid arthritis: data from the inbuild trial |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10412475/ https://www.ncbi.nlm.nih.gov/pubmed/37209188 http://dx.doi.org/10.1007/s10067-023-06623-7 |
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