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Background <p>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<sup>®</sup>) to a generic formulation affects treatment efficacy or tolerability.</p> Methods <p>We conducted a retrospective, within-patient observational study including consecutive patients with IPF treated with Esbriet<sup>®</sup> for ≥ 6&#xa0;months before switching to generic pirfenidone. Pulmonary function was assessed at three time points: 6&#xa0;months before the switch (T − 6), at switch (T0), and 6&#xa0;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.</p> Results <p>Sixty-five patients (median age 77.0&#xa0;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.</p> Conclusions <p>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.</p>

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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年4月17日

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

摘要

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.