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Respiratory Research
Published in: Respiratory Research 1/2021

Open Access 01-12-2021 | Idiopathic Pulmonary Fibrosis | Research

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

Authors: Manon Belhassen, Faustine Dalon, Maëva Nolin, Eric Van Ganse

Published in: Respiratory Research | Issue 1/2021

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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.
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Literature
1.
2.
Ley B, Collard HR, King TE Jr. Clinical course and prediction of survival in idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 2011;183:431–40.PubMedCrossRef
3.
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;377:1760–9.PubMedCrossRef
4.
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;370:2083–92.PubMedCrossRef
5.
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.PubMedCrossRef
6.
Ley B, Swigris J, Day BM, Stauffer JL, Raimundo K, Chou W, Collard HR. Pirfenidone reduces respiratory-related hospitalizations in idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 2017;196:756–61.PubMedPubMedCentralCrossRef
7.
Richeldi L, du Bois RM, Raghu G, Azuma A, Brown KK, Costabel U, Cottin V, Flaherty KR, Hansell DM, Inoue Y, et al. Efficacy and safety of nintedanib in idiopathic pulmonary fibrosis. N Engl J Med. 2014;370:2071–82.PubMedCrossRef
8.
Richeldi L, Cottin V, du Bois RM, Selman M, Kimura T, Bailes Z, Schlenker-Herceg R, Stowasser S, Brown KK. Nintedanib in patients with idiopathic pulmonary fibrosis: combined evidence from the TOMORROW and INPULSIS® trials. Respir Med. 2016;113:74–9.PubMedCrossRef
9.
Raghu G, Collard HR, Anstrom KJ, Flaherty KR, Fleming TR, King TE Jr, Martinez FJ, Brown KK. Idiopathic pulmonary fibrosis: clinically meaningful primary endpoints in phase 3 clinical trials. Am J Respir Crit Care Med. 2012;185:1044–8.PubMedPubMedCentralCrossRef
10.
King TE Jr, Albera C, Bradford WZ, Costabel U, Du Bois RM, Leff JA, Nathan SD, Sahn SA, Valeyre D, Noble PW. All-cause mortality rate in patients with idiopathic pulmonary fibrosis. Implications for the design and execution of clinical trials. Am J Respir Crit Care Med. 2014;189:825–31.PubMedCrossRef
11.
Bradford WZ, Cohen AH, Leff JA. Selection of clinically meaningful primary endpoints in phase 3 clinical trials in idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 2013;187:1269–70.PubMedCrossRef
12.
Wells AU, Behr J, Costabel U, Cottin V, Poletti V, Richeldi L, European IPF Consensus Group, Albera C, Ancochea J, Antoniou KM, et al. Hot of the breath: mortality as a primary end-point in IPF treatment trials: the best is the enemy of the good. Thorax 2012; 67:938–940.
13.
14.
Guenther A, Krauss E, Tello S, Wagner J, Paul B, Kuhn S, Maurer O, Heinemann S, Costabel U, Barbero MAN, et al. The European IPF registry (eurIPFreg): baseline characteristics and survival of patients with idiopathic pulmonary fibrosis. Respir Res. 2018;19:141.PubMedPubMedCentralCrossRef
15.
Tuppin P, Rudant J, Constantinou P, Gastaldi-Menager C, Rachas A, de Roquefeuil L, Maura G, Caillol H, Tajahmady A, Coste J, et al. Value of a national administrative database to guide public decisions: From the systeme national d’information interregimes de l’Assurance Maladie (SNIIRAM) to the systeme national des donnees de sante (SNDS) in France. Rev Epidemiol Sante Publique. 2017;65(Suppl 4):S149–67.PubMedCrossRef
16.
Raghu G, Rochwerg B, Zhang Y, Garcia CA, Azuma A, Behr J, Brozek JL, Collard HR, Cunningham W, Homma S, et al. An official ATS/ERS/JRS/ALAT clinical practice guideline: treatment of idiopathic pulmonary fibrosis. An update of the 2011 clinical practice guideline. Am J Respir Crit Care Med. 2015;192:3–19.CrossRef
17.
Cottin V, Crestani B, Cadranel J, Cordier JF, Marchand-Adam S, Prevot G, Wallaert B, Bergot E, Camus P, Dalphin JC, et al. Recommandations pratiques pour le diagnostic et la prise en charge de la fibrose pulmonaire idiopathique—actualisation 2017. Version longue [French practical guidelines for the diagnosis and management of idiopathic pulmonary fibrosis—2017 update. Full-length version]. Rev Mal Respir. 2017;34:900–68.PubMedCrossRef
18.
Haute Autorité de Santé. Brief summary of the Transparency Committee Opinion: ESBRIET (pirfenidone). France; 2015.
19.
Haute Autorité de Santé. Brief summary of the transparency committee opinion: Ofev (nintedanib). France; 2015.
20.
Bannay A, Chaignot C, Blotiere PO, Basson M, Weill A, Ricordeau P, Alla F. The best use of the Charlson comorbidity index with electronic health care database to predict mortality. Med Care. 2016;54:188–94.PubMedCrossRef
21.
Olson AL, Swigris JJ, Lezotte DC, Norris JM, Wilson CG, Brown KK. Mortality from pulmonary fibrosis increased in the United States from 1992 to 2003. Am J Respir Crit Care Med. 2007;176:277–84.PubMedCrossRef
22.
Paterniti MO, Bi Y, Rekic D, Wang Y, Karimi-Shah BA, Chowdhury BA. Acute exacerbation and decline in forced vital capacity are associated with increased mortality in idiopathic pulmonary fibrosis. Ann Am Thorac Soc. 2017;14:1395–402.PubMedCrossRef
23.
Raghu G, Amatto VC, Behr J, Stowasser S. Comorbidities in idiopathic pulmonary fibrosis patients: a systematic literature review. Eur Respir J. 2015;46:1113–30.PubMedCrossRef
24.
Snyder L, Neely ML, Hellkamp AS, O’Brien E, de Andrade J, Conoscenti CS, Leonard T, Bender S, Gulati M, Culver DA, et al. Predictors of death or lung transplant after a diagnosis of idiopathic pulmonary fibrosis: insights from the IPF-PRO Registry. Respir Res. 2019;20:105.PubMedPubMedCentralCrossRef
25.
Brown AW, Fischer CP, Shlobin OA, Buhr RG, Ahmad S, Weir NA, Nathan SD. Outcomes after hospitalization in idiopathic pulmonary fibrosis: a cohort study. Chest. 2015;147:173–9.PubMedCrossRef
26.
27.
Rochwerg B, Neupane B, Zhang Y, Garcia CC, Raghu G, Richeldi L, Brozek J, Beyene J, Schunemann H. Treatment of idiopathic pulmonary fibrosis: a network meta-analysis. BMC Med. 2016;14:18.PubMedPubMedCentralCrossRef
28.
Skandamis A, Kani C, Markantonis SL, Souliotis K. Systematic review and network meta-analysis of approved medicines for the treatment of idiopathic pulmonary fibrosis. J Drug Assess. 2019;8:55–61.PubMedPubMedCentralCrossRef
29.
Fleetwood K, McCool R, Glanville J, Edwards SC, Gsteiger S, Daigl M, Fisher M. Systematic review and network meta-analysis of idiopathic pulmonary fibrosis treatments. J Manag Care Spec Pharm. 2017;23:S5–16.PubMed
30.
Dempsey TM, Sangaralingham LR, Yao X, Sanghavi D, Shah ND, Limper AH. Clinical effectiveness of antifibrotic medications for idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 2019;200:168–74.PubMedCrossRef
31.
Vetrano DL, Bianchini E, Onder G, Cricelli I, Cricelli C, Bernabei R, Bettoncelli G, Lapi F. Poor adherence to chronic obstructive pulmonary disease medications in primary care: role of age, disease burden and polypharmacy. Geriatr Gerontol Int. 2017;17:2500–6.PubMedCrossRef
32.
33.
Cottin V, Schmidt A, Catella L, Porte F, Fernandez-Montoya C, Le Lay K, Benard S. Burden of idiopathic pulmonary fibrosis progression: a 5-year longitudinal follow-up study. PLoS ONE. 2017;12:e0166462.PubMedPubMedCentralCrossRef
Metadata
Title
Comparative outcomes in patients receiving pirfenidone or nintedanib for idiopathic pulmonary fibrosis
Authors
Manon Belhassen
Faustine Dalon
Maëva Nolin
Eric Van Ganse
Publication date
01-12-2021
Publisher
BioMed Central
Published in
Respiratory Research / Issue 1/2021
Electronic ISSN: 1465-993X
DOI
https://doi.org/10.1186/s12931-021-01714-y

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