Efficacy and tolerability of generic pirfenidone after switch from Esbriet^® in idiopathic pulmonary fibrosis: a real-world observational study.

IF 3.8 3区医学 Q1 MEDICINE, GENERAL & INTERNAL

Internal and Emergency Medicine Pub Date : 2026-04-17 DOI:10.1007/s11739-026-04343-9

Roberto Tonelli, Maria Giulia Turchiano, Antonio Moretti, Dario Andrisani, Filippo Gozzi, Giulia Raineri, Anna Valeria Samarelli, Federica Andolfi, Valentina Ruggieri, Enrico Clini, Stefania Cerri

{"title":"Efficacy and tolerability of generic pirfenidone after switch from Esbriet® in idiopathic pulmonary fibrosis: a real-world observational study.","authors":"Roberto Tonelli, Maria Giulia Turchiano, Antonio Moretti, Dario Andrisani, Filippo Gozzi, Giulia Raineri, Anna Valeria Samarelli, Federica Andolfi, Valentina Ruggieri, Enrico Clini, Stefania Cerri","doi":"10.1007/s11739-026-04343-9","DOIUrl":null,"url":null,"abstract":"Background: Generic formulations of pirfenidone are increasingly adopted in idiopathic pulmonary fibrosis (IPF), yet real-world evidence supporting their clinical equivalence to the originator remains limited. We aimed to evaluate whether switching from branded pirfenidone (Esbriet®) to a generic formulation affects treatment efficacy or tolerability.Methods: We conducted a retrospective, within-patient observational study including consecutive patients with IPF treated with Esbriet® for ≥ 6 months before switching to generic pirfenidone. Pulmonary function was assessed at three time points: 6 months before the switch (T - 6), at switch (T0), and 6 months after (T + 6). The primary endpoint was the within-patient percentage change in FVC over two consecutive 6-month periods (T - 6 → T0 vs T0 → T + 6), analysed within a pre-specified equivalence framework (± 5 percentage points). Secondary endpoints included DLCO changes and treatment-related adverse events (AEs), analysed at the patient level using paired comparisons.Results: Sixty-five patients (median age 77.0 years [72.3-80.0] years, 78% male) had complete functional follow-up. The mean percentage decline in FVC was - 1.9% before the switch and - 1.7% after the switch. The estimated between-period difference in FVC change was 0.2 percentage points (95% CI - 1.1 to 1.5), fully contained within the pre-specified equivalence margins. Similar findings were observed for DLCO, with no significant difference between periods. Overall, 43% of patients experienced at least one AE during treatment. Gastrointestinal AEs were the most frequent, but paired analyses showed no significant difference in patient-level AE occurrence between branded and generic periods. No severe AEs or treatment discontinuations were observed.Conclusions: In this real-world cohort of patients with IPF, switching from branded to generic pirfenidone was not associated with clinically meaningful differences in lung function decline or treatment tolerability.","PeriodicalId":13662,"journal":{"name":"Internal and Emergency Medicine","volume":" ","pages":""},"PeriodicalIF":3.8000,"publicationDate":"2026-04-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Internal and Emergency Medicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s11739-026-04343-9","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}

引用次数: 0

Abstract

Background: Generic formulations of pirfenidone are increasingly adopted in idiopathic pulmonary fibrosis (IPF), yet real-world evidence supporting their clinical equivalence to the originator remains limited. We aimed to evaluate whether switching from branded pirfenidone (Esbriet^®) to a generic formulation affects treatment efficacy or tolerability.

Methods: We conducted a retrospective, within-patient observational study including consecutive patients with IPF treated with Esbriet^® for ≥ 6 months before switching to generic pirfenidone. Pulmonary function was assessed at three time points: 6 months before the switch (T - 6), at switch (T0), and 6 months after (T + 6). The primary endpoint was the within-patient percentage change in FVC over two consecutive 6-month periods (T - 6 → T0 vs T0 → T + 6), analysed within a pre-specified equivalence framework (± 5 percentage points). Secondary endpoints included DLCO changes and treatment-related adverse events (AEs), analysed at the patient level using paired comparisons.

Results: Sixty-five patients (median age 77.0 years [72.3-80.0] years, 78% male) had complete functional follow-up. The mean percentage decline in FVC was - 1.9% before the switch and - 1.7% after the switch. The estimated between-period difference in FVC change was 0.2 percentage points (95% CI - 1.1 to 1.5), fully contained within the pre-specified equivalence margins. Similar findings were observed for DLCO, with no significant difference between periods. Overall, 43% of patients experienced at least one AE during treatment. Gastrointestinal AEs were the most frequent, but paired analyses showed no significant difference in patient-level AE occurrence between branded and generic periods. No severe AEs or treatment discontinuations were observed.

Conclusions: In this real-world cohort of patients with IPF, switching from branded to generic pirfenidone was not associated with clinically meaningful differences in lung function decline or treatment tolerability.

查看原文本刊更多论文

从Esbriet®切换到非尼酮治疗特发性肺纤维化的疗效和耐受性：一项真实世界的观察性研究

背景：吡非尼酮的仿制制剂越来越多地用于特发性肺纤维化（IPF），但支持其临床等效性的实际证据仍然有限。我们的目的是评估从品牌吡非尼酮（Esbriet®）转换为仿制制剂是否会影响治疗疗效或耐受性。方法：我们进行了一项回顾性的患者内观察性研究，包括连续接受Esbriet®治疗≥6个月的IPF患者，然后改用非非尼酮。在三个时间点评估肺功能：切换前6个月（T - 6），切换时（T0）和切换后6个月（T + 6）。主要终点是连续两个6个月期间患者内FVC的百分比变化（T - 6→T0 vs T0→T + 6），在预先指定的等效框架内进行分析（±5个百分点）。次要终点包括DLCO变化和治疗相关不良事件（ae），在患者水平上使用配对比较进行分析。结果：65例患者（中位年龄77.0岁[72.3-80.0]岁，男性78%）功能随访完整。植被覆盖度的平均百分比下降前为- 1.9%，转换后为- 1.7%。估计FVC变化的期间间差异为0.2个百分点（95% CI - 1.1至1.5），完全包含在预先指定的等效范围内。在DLCO中观察到类似的结果，不同时期之间没有显著差异。总体而言，43%的患者在治疗期间至少经历了一次AE。胃肠道不良事件发生率最高，但配对分析显示，品牌期和仿制期患者水平不良事件发生率无显著差异。没有观察到严重的不良反应或治疗中断。结论：在这个真实世界的IPF患者队列中，从品牌吡非尼酮切换到非专利吡非尼酮与肺功能下降或治疗耐受性的临床意义差异无关。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Internal and Emergency Medicine 医学-医学：内科

CiteScore

7.20

自引率

4.30%

发文量

258

审稿时长

6-12 weeks

期刊介绍： Internal and Emergency Medicine (IEM) is an independent, international, English-language, peer-reviewed journal designed for internists and emergency physicians. IEM publishes a variety of manuscript types including Original investigations, Review articles, Letters to the Editor, Editorials and Commentaries. Occasionally IEM accepts unsolicited Reviews, Commentaries or Editorials. The journal is divided into three sections, i.e., Internal Medicine, Emergency Medicine and Clinical Evidence and Health Technology Assessment, with three separate editorial boards. In the Internal Medicine section, invited Case records and Physical examinations, devoted to underlining the role of a clinical approach in selected clinical cases, are also published. The Emergency Medicine section will include a Morbidity and Mortality Report and an Airway Forum concerning the management of difficult airway problems. As far as Critical Care is becoming an integral part of Emergency Medicine, a new sub-section will report the literature that concerns the interface not only for the care of the critical patient in the Emergency Department, but also in the Intensive Care Unit. Finally, in the Clinical Evidence and Health Technology Assessment section brief discussions of topics of evidence-based medicine (Cochrane’s corner) and Research updates are published. IEM encourages letters of rebuttal and criticism of published articles. Topics of interest include all subjects that relate to the science and practice of Internal and Emergency Medicine.