Observational studyInternal and emergency medicine2026
Efficacy and tolerability of generic pirfenidone after switch from Esbriet
Observational study in Internal and emergency medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundGeneric 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
methodsWe conducted a retrospective, within-patient observational study including consecutive patients with IPF treated with Esbriet
resultsSixty-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.
conclusionsIn 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.
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