Contributors: 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 (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); Centre Hospitalier Universitaire de Rennes [CHU Rennes] = Rennes University Hospital [Ponchaillou]; AP-HP - Hôpital Bichat - Claude Bernard [Paris]; CHU Dijon; Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon); Centre Hospitalier Régional Universitaire [CHU Lille] (CHRU Lille); Université de 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); 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
نبذة مختصرة : 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).
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