Short- and long-term clinical outcomes of nintedanib therapy in IPF patients with different phenotypes: A retrospective registry-based study
Language English Country England, Great Britain Media print-electronic
Document type Journal Article, Observational Study, Multicenter Study, Research Support, Non-U.S. Gov't
PubMed
39255912
DOI
10.1016/j.rmed.2024.107791
PII: S0954-6111(24)00266-X
Knihovny.cz E-resources
- Keywords
- Idiopathic pulmonary fibrosis, Lung, Survival, Treatment,
- MeSH
- Antifibrotic Agents therapeutic use MeSH
- Time Factors MeSH
- Phenotype MeSH
- Idiopathic Pulmonary Fibrosis * drug therapy mortality physiopathology MeSH
- Indoles * therapeutic use MeSH
- Middle Aged MeSH
- Humans MeSH
- Proportional Hazards Models MeSH
- Registries MeSH
- Retrospective Studies MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Vital Capacity MeSH
- Treatment Outcome MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
- Observational Study MeSH
- Research Support, Non-U.S. Gov't MeSH
- Names of Substances
- Antifibrotic Agents MeSH
- Indoles * MeSH
- nintedanib MeSH Browser
BACKGROUND: There is a lack of data on the long-term effect of nintedanib on survival in specific groups of idiopathic pulmonary fibrosis (IPF) patients with different phenotypes. We investigated the outcomes of nintedanib therapy in an observational study of a large multicentre real-world cohort of IPF patients with various initial characteristics. METHODS: The analysis included IPF patients treated with nintedanib (NIN) and IPF patients not receiving antifibrotic treatment (NAF) enrolled for the EMPIRE registry in 2015-2020. The patients were stratified according to their initial FVC predicted, dyspnoea, UIP pattern and age. All-cause mortality and annual rate of FVC decline were the main endpoints. Cox proportional hazards model for survival assessment and linear mixed-effects model for FVC decline modelling were used. RESULTS: A total of 869 NIN patients and 691 NAF patients were eligible for the analysis. The annual FVC decline rate was significantly different (adjusted values -0.053 l/yr vs -0.122 l/yr; p = 0.001). The adjusted hazard ratio (HR) for mortality was 0.40 (95 % CI 0.3 to 0.53, p < 0.001). The most significant effect of nintedanib was demonstrated in patients with impaired lung function, i.e., with an FVC predicted to be less than 80 % and a NYHA II to IV. Nintedanib therapy also reduced the difference in survival between men and women. CONCLUSIONS: Modelling confirmed that NIN therapy reduced differences in OS between patients with better and worse initial conditions and prognosis. Our results indicate that NIN is particularly beneficial for patients with advanced IPF and more severe phenotypes. TRIAL REGISTRATION: EMPIRE was registered as a non-interventional post-registration study at the State Institute for Drug Control of the Czech Republic under ID 1412080000 on December 8, 2014.
1st Department of Pulmonary Diseases Institute of Tuberculosis and Lung Diseases Warsaw Poland
Department of Chest Diseases Faculty of Medicine Ege University Izmir Turkey
Department of Pneumology University Hospital Ostrava Czech Republic
Department of Pulmonology Faculty of Medicine Semmelweis University Budapest Hungary
Department of Pulmonology University Hospital Dubrava Zagreb Croatia
Department of Respiratory Medicine Paracelsus Medical University Salzburg Austria
Department of Respiratory Medicine Thomayer University Hospital Prague Czech Republic
Department of Respiratory Medicine University Hospital Olomouc Czech Republic
Institute of Biostatistics and Analyses Faculty of Medicine Masaryk University Brno Czech Republic
National Institute of Tuberculosis Respiratory Diseases and Chest Surgery Vyšné Hagy Slovakia
References provided by Crossref.org
