Modelling of Overall Survival of IPF Patients With Different Phenotypes Treated With Nintedanib
Bildiriler > Özet Bildiri
Yazarlar: M.K. Vasakova, J. Gregor, N. Mogulkoc Bishop, M. Kramer, K. Lewandowska, M. Sterclova, V. Müller, R. Slivka, M.J. Studnicka, M. Plackova, M. Zurkova, J. Tekavec-Trkanjec, M. Doubkova, P. Ovesna
American Journal of Respiratory and Critical Care Medicine, , , Uluslararası, Özet Bildiri, Wos, cilt 211, ss A2925-A2925
DOI: 10.1164/ajrccm.2025.211.abstracts.a2925
Özet
Abstract Rationale: Nintedanib (NIN) is to date used for treatment of idiopathic pulmonary fibrosis ( IPF) for more than 10 years. This tyrosine-kinase inhibitor showed effect on both, lung function decline, in clinical trials, and on overall survival, in real world. However there is a lack of data on the long-term effect of NIN on survival in patients with IPF with different phenotypes. We investigated the outcome associated with NIN in a large multicentre real-world observational cohort of IPF patients. The different phenotypes were defined by the following patient characteristics at the start of follow-up: age, sex, FVC and dyspnoea by NYHA functional class. Methods: The analysis included IPF patients treated with nintedanib (NIN) and those not receiving antifibrotic treatment (NAF); both groups were enrolled into the EMPIRE registry in 2015-2020. The patients were stratified according to sex, age (<60, 60-70 and >70 years), FVC predicted (>80%; 50-80% and <50%) and dyspnoea (NYHA FC). All-cause mortality was the main endpoint. Cox proportional hazard models were built for overall survival (OS) with treatment (NIN vs NAF) as the dependent variable. Sex, age, FVC predicted, and dyspnoea were analysed as effect-modifying variables. Using this model, survival for different subgroups was estimated.Results: A total of 869 NIN and 691 NAF patients were eligible for the analysis. NIN therapy reduced the overall risk of mortality in the total cohort by 60 % (adjusted hazard ratio [HR] 0.40; 95% CI 0.30 to 0.53, p < 0.001). The most significant difference between NIN and NAF in OS rates was seen in patients with higher age (>70 years) and functionally advanced disease (FVC<50%) and NYHA FC of III or IV (HRs for mortality in subgroups ranging between 0.20 to 0.37 for men and 0.33 to 0.61 in women).Conclusions: We observed that NIN therapy significantly reduced differences in OS between the subgroups of IPF patients. This survival difference was most marked in men, elderly patients presenting with low FVC and worse dyspnoea at the time of diagnosis. These observational data indicate that NIN might be particularly beneficial for the patients with severely impaired functional status (lung function, NYHA); however, interpretation must be cautious due to the possibility of diagnostic bias or selection bias.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 8 December 2014.