The effect of nintedanib on lung functions and survival in idiopathic pulmonary fibrosis: real-life analysis of the Czech EMPIRE registry
Jazyk angličtina Země Velká Británie, Anglie Médium electronic
Typ dokumentu časopisecké články
PubMed
37138274
PubMed Central
PMC10155319
DOI
10.1186/s12890-023-02450-3
PII: 10.1186/s12890-023-02450-3
Knihovny.cz E-zdroje
- Klíčová slova
- Idiopathic pulmonary fibrosis, Lung function decline, Nintedanib, Overall survival,
- MeSH
- idiopatická plicní fibróza * farmakoterapie MeSH
- lidé MeSH
- plíce MeSH
- registrace MeSH
- vitální kapacita MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- Geografické názvy
- Česká republika MeSH
- Názvy látek
- nintedanib MeSH Prohlížeč
INTRODUCTION: The antifibrotic drug nintedanib is used for the treatment of idiopathic pulmonary fibrosis (IPF). We analysed the effect of nintedanib on antifibrotic treatment outcome in real-world cohorts of Czech EMPIRE registry. PATIENTS/METHODS: Data of 611 Czech IPF subjects, 430 (70%) treated with nintedanib (NIN group), 181 (30%) with no-antifibrotic treatment (NAF group) were analysed. The influence of nintedanib on overall survival (OS), pulmonary function parameters as forced vital capacity (FVC) and diffusing lung capacity for carbon monoxide (DLCO), as well as GAP score (gender, age, physiology) and and CPI (composite physiological index) were investigated. RESULTS: During 2 year follow-up we observed that nintedanib treated patients had longer OS, compared to those treated with no-antifibrotic drugs (p < 0.00001). Nintedanib reduces risk of mortality over no-antifibrotic treatment by 55% (p < 0.001). We have observed no significant difference in the rate of FVC and DLCO decline between the NIN and NAF group. Changes within 24 months from baseline in CPI were not significant between the groups (NAF and NIN). CONCLUSION: Our real-practice study showed the benefit of nintedanib treatment on survival. There were no significant differences between NIN and NAF groups in changes from baseline in FVC %, DLCO % predicted and CPI.
Department of Pulmonary Medicine and Allergology Hospital Kromeriz Kromeriz Czech Republic
Department of Pulmonary Medicine and Thoracic Surgery Hospital Na Bulovce Prague Czech Republic
Department of Pulmonary Medicine Hospital Ceske Budejovice Ceske Budejovice Czech Republic
Department of Pulmonary Medicine Hospital Jihlava Jihlava Czech Republic
Department of Pulmonary Medicine Hospital Novy Jicin Novy Jicin Czech Republic
Department of Pulmonary Medicine Regional Hospital Pardubice Pardubice Czech Republic
Department of Pulmonary Medicine Tomas Bata Regional Hospital Zlin Czech Republic
Department of Pulmonary Medicine University Hospital Plzen Pilsen Czech Republic
Institute of Biostatistics and Analyses Faculty of Medicine Masaryk University Brno Czech Republic
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Raghu G, Collard HR, Egan JJ, Martinez FJ, Behr J, Brown KK, Colby TV, Cordier JF, Flaherty KR, Lasky JA, Lynch DA, Ryu JH, Swigris JJ, Wells AU, Ancochea J, Bouros D, Carvalho C, Costabel U, Ebina M, Hansell DM, Johkoh T, Kim DS, King TE, Jr, Kondoh Y, Myers J, Müller NL, Nicholson AG, Richeldi L, Selman M, Dudden RF, Griss BS, Protzko SL, Schünemann HJ. An official ATS/ERS/JRS/ALAT statement: idiopathic pulmonary fibrosis: evidence-based guidelines for diagnosis and management. Am J Respir Crit Care Med. 2011;183:788–824. doi: 10.1164/rccm.2009-040GL. PubMed DOI PMC
Doubková M, Švancara J, Svoboda M, Šterclová M, Bartoš V, Plačková M, Lacina L, Žurková M, Binková I, Bittenglová R, Lošťáková V, Merta Z, Šišková L, Tyl R, Lisá P, Šuldová H, Petřík F, Pšikalová J, Řihák V, Snížek T, Reiterer P, Homolka J, Musilová P, Lněnička J, Palúch P, Hrdina R, Králová R, Hortvíková H, Strenková J, Vašáková MEMPIRE, Registry. Czech Part: Impact of demographics, pulmonary function and HRCT on survival and clinical course in idiopathic pulmonary fibrosis. Clin Respir J. 2018;12:1526–35. PubMed
Ley B, Collard HR. Epidemiology of idiopathic pulmonary fibrosis. Clin Epidemiol. 2013;5:483–92. doi: 10.2147/CLEP.S54815. PubMed DOI PMC
King TE, Jr, Bradford WZ, Castro-Bernardini S, Fagan EA, Glaspole I, Glassberg MK, Gorina E, Hopkins PM, Kardatzke D, Lancaster L, Lederer DJ, Nathan SD, Pereira CA, Sahn SA, Sussman R, Swigris JJ, Noble PW. ASCEND Study Group. A phase 3 trial of pirfenidone in patients with idiopathic pulmonary fibrosis. N Engl J Med. 2014;370:2083–92. doi: 10.1056/NEJMoa1402582. PubMed DOI
Noble PW, Albera C, Bradford WZ, Costabel U, Glassberg MK, Kardatzke D, King TE, Jr, Lancaster L, Sahn SA, Szwarcberg J, Valeyre D, du Bois RM, CAPACITY Study Group CAPACITY study group Pirfenidone in patients with idiopathic pulmonary fibrosis (CAPACITY): two randomised trials. Lancet. 2011;377:1760–9. doi: 10.1016/S0140-6736(11)60405-4. PubMed DOI
Fisher M, Nathan SD, Hill C, Marshall J, Dejonckheere F, Thuresson PO, Maher TM. Predicting Life Expectancy for Pirfenidone in Idiopathic Pulmonary Fibrosis. J Manag Care Spec Pharm. 2017;23:17–24. PubMed PMC
Zurkova M, Kriegova E, Kolek V, Lostakova V, Sterclova M, Bartos V, Doubkova M, Binkova I, Svoboda M, Strenkova J, Janotova M, Plackova M, Lacina L, Rihak V, Petrik F, Lisa P, Bittenglova R, Tyl R, Ondrejka G, Suldova H, Lnenicka J, Psikalova J, Snizek T, Homolka J, Kralova R, Kervitzer J, Vasakova M. ILD section; IPF registry. Effect of pirfenidone on lung function decline and survival: 5-yr experience from a real-life IPF cohort from the Czech EMPIRE registry. Respir Res. 2019;20:16. doi: 10.1186/s12931-019-0977-2. PubMed DOI PMC
Májek O, Gregor J, Mogulkoć N, Lewandowska K, Šterclová M, Müller V, Hájková M, Kramer MR, Tekavec-Trkanjec J, Jovanović D, Studnicka M, Stoeva N, Kirchgässler KU, Littnerová S, Dušek L, Vašáková MK. Survival and lung function decline in patients with definite, probable and possible idiopathic pulmonary fibrosis treated with pirfenidone. PLoS ONE. 2022;17:e0273854. doi: 10.1371/journal.pone.0273854. PubMed DOI PMC
Wollin L, Wex E, Pautsch A, Schnapp G, Hostettler KE, Stowasser S, Kolb M. Mode of action of nintedanib in the treatment of idiopathic pulmonary fibrosis. Eur Respir J. 2015;45:1434–45. doi: 10.1183/09031936.00174914. PubMed DOI PMC
Richeldi L, du Bois RM, Raghu G, Azuma A, Brown KK, Costabel U, Cottin V, Flaherty KR, Hansell DM, Inoue Y, Kim DS, Kolb M, Nicholson AG, Noble PW, Selman M, Taniguchi H, Brun M, Le Maulf F, Girard M, Stowasser S, Schlenker-Herceg R, Disse B, Collard HR. INPULSIS Trial Investigators. Efficacy and safety of nintedanib in idiopathic pulmonary fibrosis. N Engl J Med. 2014;370:2071–82. doi: 10.1056/NEJMoa1402584. PubMed DOI
Vasakova M, Sterclová M. Idiopathic pulmonary fibrosis – recommendations for the diagnostics, treatment and follow-up (2. Up-date) [in Czech]. 2019. http://www.pneumologie.cz/guidelines. Accessed 15. Sept 2022.
Miller MR, Hankinson J, Brusasco V, et al. Standardisation of spirometry. Eur Respir J. 2005;26:319–38. doi: 10.1183/09031936.05.00034805. PubMed DOI
Wanger J, Clausen JL, Coates A, et al. Standardisation of the measurement of lung volumes. Eur Respir J. 2005;26:511–22. doi: 10.1183/09031936.05.00035005. PubMed DOI
Macintyre N, Crapo RO, Viegi G, et al. Standardisation of the single-breath determination of carbon monoxide uptake in the lung. Eur Respir J. 2005;26:720–35. doi: 10.1183/09031936.05.00034905. PubMed DOI
Ley B, Ryerson CJ, Vittinghoff E, Ryu JH, Tomassetti S, Lee JS, Poletti V, Buccioli M, Elicker BM, Jones KD, King TE, Jr, Collard HR. A multidimensional index and staging system for idiopathic pulmonary fibrosis. Ann Intern Med. 2012;156:684–91. doi: 10.7326/0003-4819-156-10-201205150-00004. PubMed DOI
Lynch JP, 3rd, Huynh RH, Fishbein MC, Saggar R, Belperio JA, Weigt SS. Idiopathic pulmonary fibrosis: epidemiology, clinical features, prognosis, and management. Semin Respir Crit Care Med. 2016;37:331–57. doi: 10.1055/s-0036-1582011. PubMed DOI
Wells AU, Desai SR, Rubens MB, Goh NS, Cramer D, Nicholson AG, Colby TV, du Bois RM, Hansell DM. Idiopathic pulmonary fibrosis: a composite physiologic index derived from disease extent observed by computed tomography. Am J Respir Crit Care Med. 2003;167:962–9. doi: 10.1164/rccm.2111053. PubMed DOI
Costabel U, Inoue Y, Richeldi L, Collard HR, Tschoepe I, Stowasser S, Azuma A. Efficacy of Nintedanib in Idiopathic Pulmonary Fibrosis across Prespecified Subgroups in INPULSIS. Am J Respir Crit Care Med. 2016;193:178–85. doi: 10.1164/rccm.201503-0562OC. PubMed DOI
Raghu G, Wells AU, Nicholson AG, Richeldi L, Flaherty KR, Le Maulf F, Stowasser S, Schlenker-Herceg R, Hansell DM. Effect of Nintedanib in Subgroups of Idiopathic Pulmonary Fibrosis by Diagnostic Criteria. Am J Respir Crit Care Med. 2017;195:78–85. doi: 10.1164/rccm.201602-0402OC. PubMed DOI PMC
Brown KK, Flaherty KR, Cottin V, Raghu G, Inoue Y, Azuma A, Huggins JT, Richeldi L, Stowasser S, Stansen W, Schlenker-Herceg R, Maher TM, Wells AU. Lung function outcomes in the INPULSIS® trials of nintedanib in idiopathic pulmonary fibrosis. Respir Med. 2019;146:42–8. doi: 10.1016/j.rmed.2018.11.012. PubMed DOI
Ryerson CJ, Kolb M, Richeldi L, Lee J, Wachtlin D, Stowasser S, Poletti V. Effects of nintedanib in patients with idiopathic pulmonary fibrosis by GAP stage. ERJ Open Res. 2019;5:00127–2018. doi: 10.1183/23120541.00127-2018. PubMed DOI PMC
Pellegrino R, Viegi G, Brusasco V, et al. Interpretative strategies for lung function tests. Eur Respir J. 2005;26:948. doi: 10.1183/09031936.05.00035205. PubMed DOI
Gläser S, Noga O, Koch B, et al. Impact of pulmonary hypertension on gas exchange and exercise capacity in patients with pulmonary fibrosis. Respir Med. 2009;103:317–24. doi: 10.1016/j.rmed.2008.08.005. PubMed DOI
Lee SH, Park JS, Kim SY, Kim DS, Kim YW, Chung MP, Uh ST, Park CS, Park SW, Jeong SH, Park YB, Lee HL, Shin JW, Lee EJ, Lee JH, Jegal Y, Lee HK, Kim YH, Song JW, Park MS. Comparison of CPI and GAP models in patients with idiopathic pulmonary fibrosis: a nationwide cohort study. Sci Rep. 2018;8:4784. doi: 10.1038/s41598-018-23073-3. PubMed DOI PMC
Wells A, Behr J, Stansen W, Stowasser S, Maher TM. Effect of nintedanib on composite physiologic index (CPI) in idiopathic pulmonary fibrosis (IPF). Eur Respir J. 2017;50 Suppl 61.
Wells A, Behr J, Stansen W, Stowasser S, Maher T. Effect of baseline composite physiologic index on benefit of nintedanib in IPF. Eur Respir J. 2016;48 Suppl 60.