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
. 2021 May 4;22(1):135.
doi: 10.1186/s12931-021-01714-y.

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

Manon Belhassen  1 , Faustine Dalon  1 , Maëva Nolin  1 , Eric Van Ganse  2   3   4
Affiliations
Observational Study

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

Manon Belhassen et al. Respir Res. .

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.

Keywords: Acute hospitalisations; Antifibrotics; Idiopathic pulmonary fibrosis; Mortality.

PubMed Disclaimer

Conflict of interest statement

F. Dalon, M. Nolin and M. Belhassen are full-time employees of PELyon. E. Van Ganse is the scientific advisor of PELyon.

Figures

Fig. 1
Fig. 1
Patient flowchart
Fig. 2
Fig. 2
Comparison of outcomes in patients newly treated with pirfenidone or nintedanib. a Comparison of overall mortality in patients newly treated with pirfenidone or nintedanib;a b Comparison of acute respiratory-related hospital admissions during the drug-exposure period in patients newly treated with pirfenidone or nintedanib;b c Comparative incidence of discontinuation of pirfenidone or nintedanib treatment.b CI confidence interval, m month, y year. aCumulative mortality was estimated using a cumulative incidence function. bCumulative incidence was estimated using a cumulative incidence function. The coloured areas represent the 95% CI
See this image and copyright information in PMC

References

    1. Richeldi L, Collard HR, Jones MG. Idiopathic pulmonary fibrosis. Lancet. 2017;389:1941–1952. - PubMed
    1. Ley B, Collard HR, King TE., Jr Clinical course and prediction of survival in idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 2011;183:431–440. - PubMed
    1. Noble PW, Albera C, Bradford WZ, Costabel U, Glassberg MK, Kardatzke D, King TE, Jr, Lancaster L, Sahn SA, Szwarcberg J, et al. Pirfenidone in patients with idiopathic pulmonary fibrosis (CAPACITY): two randomised trials. Lancet. 2011;377:1760–1769. - PubMed
    1. King TE, Jr, Bradford WZ, Castro-Bernardini S, Fagan EA, Glaspole I, Glassberg MK, Gorina E, Hopkins PM, Kardatzke D, Lancaster L, et al. A phase 3 trial of pirfenidone in patients with idiopathic pulmonary fibrosis. N Engl J Med. 2014;370:2083–2092. - PubMed
    1. Nathan SD, Albera C, Bradford WZ, Costabel U, Glaspole I, Glassberg MK, Kardatzke DR, Daigl M, Kirchgaessler KU, Lancaster LH, et al. Effect of pirfenidone on mortality: pooled analyses and meta-analyses of clinical trials in idiopathic pulmonary fibrosis. Lancet Respir Med. 2017;5:33–41. - PubMed

Publication types

MeSH terms

LinkOut - more resources