Treatment of Idiopathic Pulmonary Fibrosis with Capsule or Tablet Formulations of Pirfenidone in the Real-Life French RaDiCo-ILD Cohort.
Antifibrotic
Capsule
Idiopathic pulmonary fibrosis
Interstitial lung disease
Pirfenidone
Tablet
Journal
Advances in therapy
ISSN: 1865-8652
Titre abrégé: Adv Ther
Pays: United States
ID NLM: 8611864
Informations de publication
Date de publication:
01 2022
01 2022
Historique:
received:
20
08
2021
accepted:
12
10
2021
pubmed:
11
11
2021
medline:
9
3
2022
entrez:
10
11
2021
Statut:
ppublish
Résumé
Pirfenidone, an antifibrotic medication for idiopathic pulmonary fibrosis (IPF), is now available in France in two formulations: tablets since April 2018, and the initial capsules form. We conducted a cohort study to describe tolerance and acceptability of capsules and/or tablets of pirfenidone in patients with IPF. This study was nested within the French, non-randomized, multicenter RaDiCo-ILD (Rare Disease Cohort-Interstitial Lung Diseases). Included patients with IPF received at least one dose of pirfenidone tablets or capsules from July 2017 to June 2019 in three populations: the inclusion population (patients treated at least once with pirfenidone during the study period, n = 288); the potential switch population (patients treated with pirfenidone during the switch period starting April 2018, n = 256); the newly treated population (patients who initiated pirfenidone during the study period, n = 162). Each of those last two populations included three subgroups (tablets, capsules, and substitution). In 288 patients treated, 162 newly initiated pirfenidone during the study period: there were no meaningful differences in the baseline characteristics with the 256 patients treated during the potential switch period. In the newly treated population, 30.3% started pirfenidone treatment with tablet formulation. In the potential switch population, 44.9% of patients shifted from capsule to tablet. Half of the patients shifted to tablet formulation within the first 10 months. The mean treatment duration was 21.5 months with a mean dose of 2106.7 mg/day; 46.5% of patients discontinued treatment, mainly because of adverse events. There were fewer discontinuations in the tablets and substitution subgroups than in the capsules-only subgroup. The most reported adverse event was skin rash (11.5%). No new adverse event was identified. This real-life cohort assessing the characteristics of the prescription of pirfenidone tablets and capsules suggests a good acceptability of the tablet formulation by patients with IPF. Clinical trial registered with www.clinicaltrials.gov (NCT04238871).
Identifiants
pubmed: 34757602
doi: 10.1007/s12325-021-01961-x
pii: 10.1007/s12325-021-01961-x
doi:
Substances chimiques
Pyridones
0
Tablets
0
pirfenidone
D7NLD2JX7U
Banques de données
ClinicalTrials.gov
['NCT04238871']
Types de publication
Journal Article
Multicenter Study
Observational Study
Research Support, Non-U.S. Gov't
Langues
eng
Pagination
405-420Investigateurs
Emmanuel Bergot
(E)
Philippe Bonniaud
(P)
Arnaud Bourdin
(A)
Jacques Cadranel
(J)
Cécile Chenivesse
(C)
Vincent Cottin
(V)
Bruno Crestani
(B)
Jean-Charles Dalphin
(JC)
Claire Dromer
(C)
Emmanuel Gomez
(E)
Sandrine Hirschi
(S)
Dominique Israël-Biet
(D)
Stéphane Jouneau
(S)
Sylvain Marchand-Adam
(S)
David Montani
(D)
Hilario Nunes
(H)
Grégoire Prévot
(G)
Sébastien Quetant
(S)
Martine Reynaud-Gaubert
(M)
Dominique Valeyre
(D)
Lidwine Wemeau
(L)
Informations de copyright
© 2021. The Author(s), under exclusive licence to Springer Healthcare Ltd., part of Springer Nature.
Références
Richeldi L, Collard HR, Jones MG. Idiopathic pulmonary fibrosis. Lancet. 2017;389(10082):1941–52.
doi: 10.1016/S0140-6736(17)30866-8
Wuyts WA, Wijsenbeek M, Bondue B, et al. Idiopathic pulmonary fibrosis: best practice in monitoring and managing a relentless fibrotic disease. Respiration. 2020;99(1):73–82.
doi: 10.1159/000504763
Sauleda J, Núñez B, Sala E, Soriano JB. Idiopathic pulmonary fibrosis: epidemiology, natural history, phenotypes. Med Sci (Basel). 2018;6(4):110.
Kim DS, Collard HR, King TE Jr. Classification and natural history of the idiopathic interstitial pneumonias. Proc Am Thorac Soc. 2006;3(4):285–92.
doi: 10.1513/pats.200601-005TK
Duchemann B, Annesi-Maesano I, de Jacobe NC, et al. Prevalence and incidence of interstitial lung diseases in a multi-ethnic county of Greater Paris. Eur Respir J. 2017;50(2):1602419.
doi: 10.1183/13993003.02419-2016
Cottin V, Crestani B, Valeyre D, et al. French national reference centre; network of competence centres for rare lung diseases. Diagnosis and management of idiopathic pulmonary fibrosis: French practical guidelines. Eur Respir Rev. 2014;23(132):193–214.
doi: 10.1183/09059180.00001814
Olson AL, Gifford AH, Inase N, Fernández Pérez ER, Suda T. The epidemiology of idiopathic pulmonary fibrosis and interstitial lung diseases at risk of a progressive-fibrosing phenotype. Eur Respir Rev. 2018;27(150): 180077.
doi: 10.1183/16000617.0077-2018
Guenther A, Krauss E, Tello S, et al. The European IPF registry (eurIPFreg): baseline characteristics and survival of patients with idiopathic pulmonary fibrosis. Respir Res. 2018;19(1):141.
doi: 10.1186/s12931-018-0845-5
Raghu G, Rochwerg B, Zhang Y, 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(2):e3-19.
doi: 10.1164/rccm.201506-1063ST
Raghu G, Remy-Jardin M, Myers JL, et al. American Thoracic Society, European Respiratory Society, Japanese Respiratory Society, and Latin American Thoracic Society. Diagnosis of Idiopathic Pulmonary Fibrosis. An official ATS/ERS/JRS/ALAT Clinical practice guideline. Am J Respir Crit Care Med. 2018;198(5):e44–68.
doi: 10.1164/rccm.201807-1255ST
Centre de Référence des Maladies Pulmonaires Rares. Available from: http://www.maladies-pulmonaires-rares.fr/ . Accessed 28 Oct 2021.
Cottin V, Crestani B, Cadranel J, et al. French practical guidelines for the diagnosis and management of idiopathic pulmonary fibrosis-2017 update. Full-length version. Rev Mal Respir. 2017;34(8):900–68.
doi: 10.1016/j.rmr.2017.07.017
George PM, Patterson CM, Reed AK, Thillai M. Lung transplantation for idiopathic pulmonary fibrosis. Lancet Respir Med. 2019;7(3):271–82.
doi: 10.1016/S2213-2600(18)30502-2
Richeldi L, du Bois RM, Raghu G, et al. Efficacy and safety of nintedanib in idiopathic pulmonary fibrosis. N Engl J Med. 2014;370(22):2071–82.
doi: 10.1056/NEJMoa1402584
Raghu G, Johnson WC, Lockhart D, Mageto Y. Treatment of idiopathic pulmonary fibrosis with a new antifibrotic agent, pirfenidone: results of a prospective, open-label phase II study. Am J Respir Crit Care Med. 1999;159(4 Pt 1):1061–9.
doi: 10.1164/ajrccm.159.4.9805017
Takeda Y, Tsujino K, Kijima T, Kumanogoh A. Efficacy and safety of pirfenidone for idiopathic pulmonary fibrosis. Patient Prefer Adher. 2014;21(8):361–70.
doi: 10.2147/PPA.S37233
Summary of Product Characteristics (SmPC) Esbriet®. Available from: https://www.ema.europa.eu/en/documents/product-information/esbriet-epar-product-information_en.pdf . Accessed 28 Oct 2021.
Noble PW, Albera C, Bradford WZ, et al. Pirfenidone for idiopathic pulmonary fibrosis: analysis of pooled data from three multinational phase 3 trials. Eur Respir J. 2016;47(1):243–53.
doi: 10.1183/13993003.00026-2015
Cottin V, Koschel D, Günther A, et al. Long-term safety of pirfenidone: results of the prospective, observational PASSPORT study. ERJ Open Res. 2018;4(4):00084–2018.
doi: 10.1183/23120541.00084-2018
Jouneau S, Gamez AS, Traclet J, et al. A 2-year observational study in patients suffering from idiopathic pulmonary fibrosis and treated with pirfenidone: a French ancillary study of PASSPORT. Respiration. 2019;98(1):19–28.
doi: 10.1159/000496735
Pan L, Belloni P, Ding HT, Wang J, Rubino CM, Putnam WS. A pharmacokinetic bioequivalence study comparing pirfenidone tablet and capsule dosage forms in healthy adult volunteers. Adv Ther. 2017;34(9):2071–82.
doi: 10.1007/s12325-017-0594-8
Lancaster LH, Valenzuela C, Mason W, et al. Patients’ and healthcare professionals’ experiences of idiopathic pulmonary fibrosis treatment with the pirfenidone 801 mg tablet formulation: a multinational survey. Pulm Ther. 2020;6(1):93–105.
doi: 10.1007/s41030-020-00111-y
Cottin V, Jouneau S, Crestani B, et al. Demographics and baseline characteristics of patients with idiopathic pulmonary fibrosis (IPF) in a real-world setting: results of 847 patients enrolled in the Radico-ILD Cohort in France. Am J Respir Crit Care Med. 2020;201:A3349.
Behr J, Kreuter M, Hoeper MM, et al. Management of patients with idiopathic pulmonary fibrosis in clinical practice: the INSIGHTS-IPF registry. Eur Respir J. 2015;46(1):186–96.
doi: 10.1183/09031936.00217614
Tran T, Šterclová M, Mogulkoc N, et al. The European MultiPartner IPF registry (EMPIRE): validating long-term prognostic factors in idiopathic pulmonary fibrosis. Respir Res. 2020;21(1):11.
doi: 10.1186/s12931-019-1271-z
Karahalios A, Baglietto L, Carlin JB, English DR, Simpson JA. A review of the reporting and handling of missing data in cohort studies with repeated assessment of exposure measures. BMC Med Res Methodol. 2012;12:96.
doi: 10.1186/1471-2288-12-96
Ferrara G, Carlson L, Palm A, Einarsson J, Olivesten C, Sköld M. Idiopathic pulmonary fibrosis in Sweden: report from the first year of activity of the Swedish IPF-Registry. Eur Clin Respir J. 2016;3:31090.
doi: 10.3402/ecrj.v3.31090
Wuyts WA, Dahlqvist C, Slabbynck H, et al. Baseline clinical characteristics, comorbidities and prescribed medication in a real-world population of patients with idiopathic pulmonary fibrosis: the PROOF registry. BMJ Open Respir Res. 2018;5(1): e000331.
doi: 10.1136/bmjresp-2018-000331
Sköld CM, Arnheim-Dahlström L, Bartley K, et al. Patient journey and treatment patterns in adults with IPF based on health care data in Sweden from 2001 to 2015. Respir Med. 2019;155:72–8.
doi: 10.1016/j.rmed.2019.06.001
Nathan SD, Lancaster LH, Albera C, et al. Dose modification and dose intensity during treatment with pirfenidone: analysis of pooled data from three multinational phase III trials. BMJ Open Respir Res. 2018;5(1): e000323.
doi: 10.1136/bmjresp-2018-000323
Hughes G, Toellner H, Morris H, Leonard C, Chaudhuri N. Real world experiences: pirfenidone and nintedanib are effective and well tolerated treatments for idiopathic pulmonary fibrosis. J Clin Med. 2016;5(9):78.
doi: 10.3390/jcm5090078
Galli JA, Pandya A, Vega-Olivo M, Dass C, Zhao H, Criner GJ. Pirfenidone and nintedanib for pulmonary fibrosis in clinical practice: tolerability and adverse drug reactions. Respirology. 2017;22(6):1171–8.
doi: 10.1111/resp.13024
Cottin V, Maher T. Long-term clinical and real-world experience with pirfenidone in the treatment of idiopathic pulmonary fibrosis. Eur Respir Rev. 2015;24(135):58–64.
doi: 10.1183/09059180.00011514
Kreuter M, Swigris J, Pittrow D, et al. Health related quality of life in patients with idiopathic pulmonary fibrosis in clinical practice: insights-IPF registry. J Respir Res. 2017;18(1):139.
doi: 10.1186/s12931-017-0621-y