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Long‐term treatment with nintedanib in Asian patients with idiopathic pulmonary fibrosis: Results from INPULSIS®‐ON

BACKGROUND AND OBJECTIVE: The efficacy and safety of nintedanib in patients with idiopathic pulmonary fibrosis (IPF) were investigated in the placebo‐controlled INPULSIS® trials. All patients who completed an INPULSIS® trial could receive open‐label nintedanib in the extension trial INPULSIS®‐ON. ME...

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Autores principales: Song, Jin Woo, Ogura, Takashi, Inoue, Yoshikazu, Xu, Zuojun, Quaresma, Manuel, Stowasser, Susanne, Stansen, Wibke, Crestani, Bruno
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley & Sons, Ltd 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7154738/
https://www.ncbi.nlm.nih.gov/pubmed/31329360
http://dx.doi.org/10.1111/resp.13647
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author Song, Jin Woo
Ogura, Takashi
Inoue, Yoshikazu
Xu, Zuojun
Quaresma, Manuel
Stowasser, Susanne
Stansen, Wibke
Crestani, Bruno
author_facet Song, Jin Woo
Ogura, Takashi
Inoue, Yoshikazu
Xu, Zuojun
Quaresma, Manuel
Stowasser, Susanne
Stansen, Wibke
Crestani, Bruno
author_sort Song, Jin Woo
collection PubMed
description BACKGROUND AND OBJECTIVE: The efficacy and safety of nintedanib in patients with idiopathic pulmonary fibrosis (IPF) were investigated in the placebo‐controlled INPULSIS® trials. All patients who completed an INPULSIS® trial could receive open‐label nintedanib in the extension trial INPULSIS®‐ON. METHODS: We assessed the long‐term efficacy and safety of nintedanib in patients of Asian race who were treated in INPULSIS®‐ON. Analyses were descriptive. RESULTS: A total of 215 Asian patients were treated in INPULSIS®‐ON, of whom 121 continued nintedanib in INPULSIS®‐ON and 94 initiated nintedanib in INPULSIS®‐ON having received placebo in an INPULSIS® trial. At baseline of INPULSIS®‐ON, the mean (SD) age of Asian patients was 66.3 (7.5) years, 80.5% were males and mean (SD) forced vital capacity (FVC) was 78.9 (19.3) % predicted. Median total exposure to nintedanib in both INPULSIS® and INPULSIS®‐ON was 42.2 months; maximum exposure was 64.1 months. In INPULSIS®, the annual rate (SE) of decline in FVC over 52 weeks in Asian patients was −124 (20) mL/year in the nintedanib group and −218 (24) mL/year in the placebo group. In INPULSIS®‐ON, the annual rate (SE) of decline in FVC over 192 weeks in Asian patients was −127 (11) mL/year. Diarrhoea was reported in Asian patients at event rates of 58.8 and 82.5 events per 100 patient exposure–years in patients who continued and initiated nintedanib in INPULSIS®‐ON, respectively. CONCLUSION: The effect of nintedanib on slowing disease progression in Asian patients with IPF is sustained over the long term. Long‐term treatment with nintedanib has an acceptable safety and tolerability profile.
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spelling pubmed-71547382020-04-15 Long‐term treatment with nintedanib in Asian patients with idiopathic pulmonary fibrosis: Results from INPULSIS®‐ON Song, Jin Woo Ogura, Takashi Inoue, Yoshikazu Xu, Zuojun Quaresma, Manuel Stowasser, Susanne Stansen, Wibke Crestani, Bruno Respirology ORIGINAL ARTICLES BACKGROUND AND OBJECTIVE: The efficacy and safety of nintedanib in patients with idiopathic pulmonary fibrosis (IPF) were investigated in the placebo‐controlled INPULSIS® trials. All patients who completed an INPULSIS® trial could receive open‐label nintedanib in the extension trial INPULSIS®‐ON. METHODS: We assessed the long‐term efficacy and safety of nintedanib in patients of Asian race who were treated in INPULSIS®‐ON. Analyses were descriptive. RESULTS: A total of 215 Asian patients were treated in INPULSIS®‐ON, of whom 121 continued nintedanib in INPULSIS®‐ON and 94 initiated nintedanib in INPULSIS®‐ON having received placebo in an INPULSIS® trial. At baseline of INPULSIS®‐ON, the mean (SD) age of Asian patients was 66.3 (7.5) years, 80.5% were males and mean (SD) forced vital capacity (FVC) was 78.9 (19.3) % predicted. Median total exposure to nintedanib in both INPULSIS® and INPULSIS®‐ON was 42.2 months; maximum exposure was 64.1 months. In INPULSIS®, the annual rate (SE) of decline in FVC over 52 weeks in Asian patients was −124 (20) mL/year in the nintedanib group and −218 (24) mL/year in the placebo group. In INPULSIS®‐ON, the annual rate (SE) of decline in FVC over 192 weeks in Asian patients was −127 (11) mL/year. Diarrhoea was reported in Asian patients at event rates of 58.8 and 82.5 events per 100 patient exposure–years in patients who continued and initiated nintedanib in INPULSIS®‐ON, respectively. CONCLUSION: The effect of nintedanib on slowing disease progression in Asian patients with IPF is sustained over the long term. Long‐term treatment with nintedanib has an acceptable safety and tolerability profile. John Wiley & Sons, Ltd 2019-07-22 2020-04 /pmc/articles/PMC7154738/ /pubmed/31329360 http://dx.doi.org/10.1111/resp.13647 Text en © 2019 The Authors. Respirology published by John Wiley & Sons Australia, Ltd on behalf of Asian Pacific Society of Respirology This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
spellingShingle ORIGINAL ARTICLES
Song, Jin Woo
Ogura, Takashi
Inoue, Yoshikazu
Xu, Zuojun
Quaresma, Manuel
Stowasser, Susanne
Stansen, Wibke
Crestani, Bruno
Long‐term treatment with nintedanib in Asian patients with idiopathic pulmonary fibrosis: Results from INPULSIS®‐ON
title Long‐term treatment with nintedanib in Asian patients with idiopathic pulmonary fibrosis: Results from INPULSIS®‐ON
title_full Long‐term treatment with nintedanib in Asian patients with idiopathic pulmonary fibrosis: Results from INPULSIS®‐ON
title_fullStr Long‐term treatment with nintedanib in Asian patients with idiopathic pulmonary fibrosis: Results from INPULSIS®‐ON
title_full_unstemmed Long‐term treatment with nintedanib in Asian patients with idiopathic pulmonary fibrosis: Results from INPULSIS®‐ON
title_short Long‐term treatment with nintedanib in Asian patients with idiopathic pulmonary fibrosis: Results from INPULSIS®‐ON
title_sort long‐term treatment with nintedanib in asian patients with idiopathic pulmonary fibrosis: results from inpulsis®‐on
topic ORIGINAL ARTICLES
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7154738/
https://www.ncbi.nlm.nih.gov/pubmed/31329360
http://dx.doi.org/10.1111/resp.13647
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