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1. Treatment of Idiopathic Pulmonary Fibrosis with Capsule or Tablet Formulations of Pirfenidone in the Real-Life French RaDiCo-ILD Cohort.

Author

Cottin, Vincent, Guéguen, Sonia, Nunes, Hilario, Jouneau, Stéphane, Crestani, Bruno, Bonniaud, Philippe, Wemeau, Lidwine, Israël-Biet, Dominique, Reynaud-Gaubert, Martine, Gondouin, Anne, Cadranel, Jacques, Marchand-Adam, Sylvain, Chevereau, Marie, Dufaure-Garé, Isabelle, Amselem, Serge, Clément, Annick, and the RaDiCo team, Bergot, Emmanuel, Bourdin, Arnaud, and Chenivesse, Cécile

Abstract

Introduction: 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. Methods: 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). Results: 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. Conclusions: 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. Trial Registration: Clinical trial registered with www.clinicaltrials.gov (NCT04238871). [ABSTRACT FROM AUTHOR]

Published
2022
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2. Treatment of Idiopathic Pulmonary Fibrosis with Capsule or Tablet Formulations of Pirfenidone in the Real-Life French RaDiCo-ILD Cohort

Author

Cottin, Vincent, Guéguen, Sonia, Nunes, Hilario, Jouneau, Stéphane, Crestani, Bruno, Bonniaud, Philippe, Wemeau, Lidwine, Israël-Biet, Dominique, Reynaud-Gaubert, Martine, Gondouin, Anne, Cadranel, Jacques, Marchand-Adam, Sylvain, Chevereau, Marie, Dufaure-Garé, Isabelle, Amselem, Serge, Clément, Annick, Bergot, Emmanuel, Bourdin, Arnaud, Chenivesse, Cécile, Dalphin, Jean-Charles, Dromer, Claire, Gomez, Emmanuel, Hirschi, Sandrine, Montani, David, Prévot, Grégoire, Quetant, Sébastien, Valeyre, Dominique, Physiologie & médecine expérimentale du Cœur et des Muscles [U 1046] (PhyMedExp), Université de Montpellier (UM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Hôpital Louis Pradel [CHU - HCL], Hospices Civils de Lyon (HCL), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon, Maladies génétiques d'expression pédiatrique [CHU Trousseau] (Inserm U933), Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Trousseau [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Hôpital Avicenne [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), CHU Pontchaillou [Rennes], AP-HP - Hôpital Bichat - Claude Bernard [Paris], CHU Dijon, Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), CHU Lille, Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), CHU Marseille, Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), CHU Tenon [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), UF de Génétique moléculaire [CHU Trousseau], CHU Trousseau [APHP], Service de Pneumologie pédiatrique [CHU Trousseau], Centre de référence national pour les maladies respiratoires rares de l’enfant RespiRare [CHU Trousseau], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-CHU Trousseau [APHP], and the RaDiCo team: Emmanuel Bergot, Philippe Bonniaud, Arnaud Bourdin, Jacques Cadranel, Cécile Chenivesse, Vincent Cottin, Bruno Crestani, Jean-Charles Dalphin, Claire Dromer, Emmanuel Gomez, Sandrine Hirschi, Dominique Israël-Biet, Stéphane Jouneau, Sylvain Marchand-Adam, David Montani, Hilario Nunes, Grégoire Prévot, Sébastien Quetant, Martine Reynaud-Gaubert, Dominique Valeyre, Lidwine Wemeau, and MORNET, Dominique

Subjects
medicine.medical_specialty, Pyridones, [SDV]Life Sciences [q-bio], Population, Interstitial lung disease, Pirfenidone, [SDV.MHEP.PSR]Life Sciences [q-bio]/Human health and pathology/Pulmonology and respiratory tract, Cohort Studies, 03 medical and health sciences, Idiopathic pulmonary fibrosis, 0302 clinical medicine, Internal medicine, medicine, Humans, Pharmacology (medical), 030212 general & internal medicine, Adverse effect, education, Capsule, ComputingMilieux_MISCELLANEOUS, education.field_of_study, business.industry, General Medicine, medicine.disease, Rash, Idiopathic Pulmonary Fibrosis, 3. Good health, Clinical trial, Treatment Outcome, 030228 respiratory system, Cohort, [SDV.MHEP.PSR] Life Sciences [q-bio]/Human health and pathology/Pulmonology and respiratory tract, France, Antifibrotic, medicine.symptom, Tablet, Lung Diseases, Interstitial, business, Tablets, Cohort study, medicine.drug
Abstract

Auteur groupe collaboratif RaDiCo team; International audience; Introduction: 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.Methods: 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).Results: 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.Conclusions: 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.Trial registration: Clinical trial registered with www.clinicaltrials.gov (NCT04238871).

Published
2021

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