Comparative outcomes in patients receiving pirfenidone or nintedanib for idiopathic pulmonary fibrosis

Abstract Background Real-world data regarding outcomes of idiopathic pulmonary fibrosis (IPF) are scarce, outside of registries. In France, pirfenidone and nintedanib are only reimbursed for documented IPF, with similar reimbursement criteria with respect to disease characteristics, prescription thr...

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Main Authors: Manon Belhassen, Faustine Dalon, Maëva Nolin, Eric Van Ganse
Format: Article
Language:English
Published: BMC 2021-05-01
Series:Respiratory Research
Subjects:
Online Access:https://doi.org/10.1186/s12931-021-01714-y
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spelling doaj-4e0a9a1630ae472384f0afad80f329c72021-05-09T11:17:13ZengBMCRespiratory Research1465-993X2021-05-0122111110.1186/s12931-021-01714-yComparative outcomes in patients receiving pirfenidone or nintedanib for idiopathic pulmonary fibrosisManon Belhassen0Faustine Dalon1Maëva Nolin2Eric Van Ganse3PELyon, PharmacoEpidemiology LyonPELyon, PharmacoEpidemiology LyonPELyon, PharmacoEpidemiology LyonPELyon, PharmacoEpidemiology LyonAbstract Background Real-world data regarding outcomes of idiopathic pulmonary fibrosis (IPF) are scarce, outside of registries. In France, pirfenidone and nintedanib are only reimbursed for documented IPF, with similar reimbursement criteria with respect to disease characteristics, prescription through a dedicated form, and IPF diagnosis established in multidisciplinary discussion. Research question The data of the comprehensive French National Health System were used to evaluate outcomes in patients newly treated with pirfenidone or nintedanib in 2015–2016. Study design and methods Patients aged < 50 years or who had pulmonary fibrosis secondary to an identified cause were excluded. All-cause mortality, acute respiratory-related hospitalisations and treatment discontinuations up to 31 December 2017 were compared using a Cox proportional hazards model adjusted for age, sex, year of treatment initiation, time to treatment initiation and proxies of disease severity identified during a pre-treatment period. Results During the study period, a treatment with pirfenidone or nintedanib was newly initiated in 804 and 509 patients, respectively. No difference was found between groups for age, sex, time to treatment initiation, Charlson comorbidity score, and number of hospitalisations or medical contacts prior to treatment initiation. As compared to pirfenidone, nintedanib was associated with a greater risk of all-cause mortality (hazard ratio [HR], 1.8; 95% confidence interval [CI] 1.3–2.6), a greater risk of acute respiratory-related hospitalisations (HR 1.3; 95% CI 1.0–1.7) and a lower risk of treatment discontinuation at 12 months (HR 0.7; 95% CI 0.6–0.9). Interpretation This observational study identified potential differences in outcome under newly prescribed antifibrotic drugs, deserving further explorations.https://doi.org/10.1186/s12931-021-01714-yIdiopathic pulmonary fibrosisAntifibroticsMortalityAcute hospitalisations
collection DOAJ
language English
format Article
sources DOAJ
author Manon Belhassen
Faustine Dalon
Maëva Nolin
Eric Van Ganse
spellingShingle Manon Belhassen
Faustine Dalon
Maëva Nolin
Eric Van Ganse
Comparative outcomes in patients receiving pirfenidone or nintedanib for idiopathic pulmonary fibrosis
Respiratory Research
Idiopathic pulmonary fibrosis
Antifibrotics
Mortality
Acute hospitalisations
author_facet Manon Belhassen
Faustine Dalon
Maëva Nolin
Eric Van Ganse
author_sort Manon Belhassen
title Comparative outcomes in patients receiving pirfenidone or nintedanib for idiopathic pulmonary fibrosis
title_short Comparative outcomes in patients receiving pirfenidone or nintedanib for idiopathic pulmonary fibrosis
title_full Comparative outcomes in patients receiving pirfenidone or nintedanib for idiopathic pulmonary fibrosis
title_fullStr Comparative outcomes in patients receiving pirfenidone or nintedanib for idiopathic pulmonary fibrosis
title_full_unstemmed Comparative outcomes in patients receiving pirfenidone or nintedanib for idiopathic pulmonary fibrosis
title_sort comparative outcomes in patients receiving pirfenidone or nintedanib for idiopathic pulmonary fibrosis
publisher BMC
series Respiratory Research
issn 1465-993X
publishDate 2021-05-01
description Abstract Background Real-world data regarding outcomes of idiopathic pulmonary fibrosis (IPF) are scarce, outside of registries. In France, pirfenidone and nintedanib are only reimbursed for documented IPF, with similar reimbursement criteria with respect to disease characteristics, prescription through a dedicated form, and IPF diagnosis established in multidisciplinary discussion. Research question The data of the comprehensive French National Health System were used to evaluate outcomes in patients newly treated with pirfenidone or nintedanib in 2015–2016. Study design and methods Patients aged < 50 years or who had pulmonary fibrosis secondary to an identified cause were excluded. All-cause mortality, acute respiratory-related hospitalisations and treatment discontinuations up to 31 December 2017 were compared using a Cox proportional hazards model adjusted for age, sex, year of treatment initiation, time to treatment initiation and proxies of disease severity identified during a pre-treatment period. Results During the study period, a treatment with pirfenidone or nintedanib was newly initiated in 804 and 509 patients, respectively. No difference was found between groups for age, sex, time to treatment initiation, Charlson comorbidity score, and number of hospitalisations or medical contacts prior to treatment initiation. As compared to pirfenidone, nintedanib was associated with a greater risk of all-cause mortality (hazard ratio [HR], 1.8; 95% confidence interval [CI] 1.3–2.6), a greater risk of acute respiratory-related hospitalisations (HR 1.3; 95% CI 1.0–1.7) and a lower risk of treatment discontinuation at 12 months (HR 0.7; 95% CI 0.6–0.9). Interpretation This observational study identified potential differences in outcome under newly prescribed antifibrotic drugs, deserving further explorations.
topic Idiopathic pulmonary fibrosis
Antifibrotics
Mortality
Acute hospitalisations
url https://doi.org/10.1186/s12931-021-01714-y
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