Comparative outcomes in patients receiving pirfenidone or nintedanib for idiopathic pulmonary fibrosis.
Aged
Aged, 80 and over
Databases, Factual
Disease Progression
Female
France
Health Status
Hospitalization
Humans
Idiopathic Pulmonary Fibrosis
/ diagnosis
Indoles
/ adverse effects
Male
Middle Aged
Pyridones
/ adverse effects
Respiratory System Agents
/ adverse effects
Risk Assessment
Risk Factors
Time Factors
Treatment Outcome
Acute hospitalisations
Antifibrotics
Idiopathic pulmonary fibrosis
Mortality
Journal
Respiratory research
ISSN: 1465-993X
Titre abrégé: Respir Res
Pays: England
ID NLM: 101090633
Informations de publication
Date de publication:
04 May 2021
04 May 2021
Historique:
received:
02
12
2020
accepted:
13
04
2021
entrez:
5
5
2021
pubmed:
6
5
2021
medline:
24
11
2021
Statut:
epublish
Résumé
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. 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. 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. 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). This observational study identified potential differences in outcome under newly prescribed antifibrotic drugs, deserving further explorations.
Sections du résumé
BACKGROUND
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
OBJECTIVE
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
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
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
CONCLUSIONS
This observational study identified potential differences in outcome under newly prescribed antifibrotic drugs, deserving further explorations.
Identifiants
pubmed: 33947414
doi: 10.1186/s12931-021-01714-y
pii: 10.1186/s12931-021-01714-y
pmc: PMC8094468
doi:
Substances chimiques
Indoles
0
Pyridones
0
Respiratory System Agents
0
pirfenidone
D7NLD2JX7U
nintedanib
G6HRD2P839
Types de publication
Journal Article
Observational Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
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