Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Observational Study
. 2024 Apr 24;11(1):e001687.
doi: 10.1136/bmjresp-2023-001687.

Antifibrotic treatment adherence, efficacy and outcomes for patients with idiopathic pulmonary fibrosis in Spain: a real-world evidence study

Ana Dolores Romero Ortiz  1 , Beatriz María Jiménez-Rodríguez  2 , Cecilia López-Ramírez  3 , Ángela López-Bauzá  3 , María Pérez-Morales  4 , José Antonio Delgado-Torralbo  5 , Cristina Villalba Moral  6 , Bernardino Alcazar-Navarrete  2   7
Affiliations
Observational Study

Antifibrotic treatment adherence, efficacy and outcomes for patients with idiopathic pulmonary fibrosis in Spain: a real-world evidence study

Ana Dolores Romero Ortiz et al. BMJ Open Respir Res. .

Abstract

Background: Idiopathic pulmonary fibrosis (IPF) is a rare disorder associated with increased mortality and morbidity. There are currently two drugs approved for IPF but their safety and efficacy profile in real-world settings in Spain is not well understood.

Methods: An observational, multicentre, prospective study was carried out among patients with IPF who started treatment with pirfenidone or nintedanib from 2015 to 2021. Data regarding clinical characteristics, drug adherence, safety profiles and clinical outcomes between these two drugs were collected.

Results: 232 patients were included in the analysis. There were no meaningful differences between both groups at baseline. Patients who started pirfenidone showed a decreased risk for treatment withdrawal compared with those starting nintedanib (HR 0.65 (95% CI 0.46 to 0.94; p=0.002)). Time to first adverse event and all-cause mortality was similar between study groups. Risk factors for withdrawal were female sex, diarrhoea and photosensitivity.

Conclusions: in this real-world study, both pirfenidone and nintedanib showed similar efficacy profiles. Pirfenidone was associated with less treatment discontinuations due to side effects.

Keywords: interstitial fibrosis.

PubMed Disclaimer

Conflict of interest statement

Competing interests: BA reports grants and personal fees from GSK, personal fees and non-financial support from Boehringer Ingelheim, personal fees and non-financial support from Chiesi, non-financial support from Laboratorios Menarini, grants, personal fees and non-financial support from AstraZeneca, personal fees from Gilead, personal fees and non-financial support from MSD, personal fees from Laboratorios BIAL, personal fees from Zambon, outside the submitted work.

Figures

Figure 1
Figure 1
Kaplan-Meier survival curves showing time (with shadow lines reflecting 95% CI) to definitive discontinuation (withdrawal) from either nintedanib (blue) or pirfenidone (red) among new antifibrotic users.
Figure 2
Figure 2
Kaplan-Meier survival curves showing time (with shadow lines reflecting 95% CI) for first reported adverse event from either nintedanib (blue) or pirfenidone (red) among new antifibrotic users.
Figure 3
Figure 3
Kaplan-Meier survival curves showing time (with shadow lines reflecting 95% CI) to death from either nintedanib (blue) or pirfenidone (red) among new antifibrotic users.
Figure 4
Figure 4
Multivariate analysis for definitive discontinuation from antifibrotic therapy. Results are expressed as HR (mean, 95% CI) for each variable. 6MWT, 6 min walking test; Charlson CI, Charlson Comorbidity Index; DLCO, lung diffusion for carbon monoxide; LFT, liver function test.
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

References

    1. Lederer DJ, Martinez FJ. Idiopathic pulmonary fibrosis. N Engl J Med 2018;378:1811–23. 10.1056/NEJMra1705751 - DOI - PubMed
    1. Richeldi L, Collard HR, Jones MG. Idiopathic pulmonary fibrosis. Lancet 2017;389:1941–52. 10.1016/S0140-6736(17)30866-8 - DOI - PubMed
    1. Soriano JB, Kendrick PJ, Paulson KR. Prevalence and attributable health burden of chronic respiratory diseases, 1990–2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet Respir Med 2020;8:585–96. 10.1016/S2213-2600(20)30105-3 - DOI - PMC - PubMed
    1. Ley B, Collard HR, King TE. Clinical course and prediction of survival in idiopathic pulmonary fibrosis. Am J Respir Crit Care Med 2011;183:431–40. 10.1164/rccm.201006-0894CI - DOI - PubMed
    1. Nathan SD, Shlobin OA, Weir N, et al. . Long-term course and prognosis of idiopathic pulmonary fibrosis in the new millennium. Chest 2011;140:221–9. 10.1378/chest.10-2572 - DOI - PubMed

Publication types

LinkOut - more resources