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Long-term safety of pirfenidone: results of the prospective, observational PASSPORT study
Open accessAbstract
Real-world studies include a broader patient population for a longer duration than randomised controlled trials (RCTs) and can provide relevant insights for clinical practice. PASSPORT was a multicentre, prospective, post-authorisation study of patients who were newly prescribed pirfenidone and followed for 2 years after initiating treatment. Physicians collected data on adverse drug reactions (ADRs), serious ADRs (SADRs) and ADRs of special interest (ADRSI) at baseline and then every 3 months.Post hocstepwise logistic regression models were used to identify baseline characteristics associated with discontinuing treatment due to an ADR. Patients (n=1009, 99.7% with idiopathic pulmonary fibrosis) had a median pirfenidone exposure of 442.0 days. Overall, 741 (73.4%) patients experienced ADRs, most commonly nausea (20.6%) and fatigue (18.5%). ADRs led to treatment discontinuation in 290 (28.7%) patients after a median of 99.5 days. Overall, 55 (5.5%) patients experienced SADRs, with a fatal outcome in six patients. ADRSI were reported in 693 patients, most commonly gastrointestinal symptoms (38.3%) and photosensitivity reactions/skin rashes (29.0%). Older age and female sex were associated with early treatment discontinuation due to an ADR. Findings were consistent with the known safety profile of pirfenidone, based on RCT data and other post-marketing experience, with no new safety signals observed.
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“Their limited efficacy, combined with tolerability challenges, contributes to low treatment uptake, frequent discontinuation of both treatments, and impaired quality of life.6-8”
From Deupirfenidone Compared with Pirfenidone and Placebo in Idiopathic Pulmonary Fibrosis (ELEVATE-IPF): a Phase 2b Randomized Placebo-Controlled Trial (2026) · cites this paper as [6]
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“however, neither drug halts disease progression, and both are associated with adverse effects that limit treatment duration (4, 5).”
From Efficacy and Safety of Admilparant, an LPA1 Antagonist, in Pulmonary Fibrosis: A Phase 2 Randomized Clinical Trial. (2025) · cites this paper as [4]
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“which can limit treatment persistence and/or require dose adjustments (4, 5).”
From Efficacy and Safety of Admilparant, an LPA1 Antagonist, in Pulmonary Fibrosis: A Phase 2 Randomized Clinical Trial. (2025) · cites this paper as [4]
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“however, neither drug halts disease progression, and both are associated with adverse effects that limit treatment duration (4, 5).”
From Efficacy and Safety of Admilparant, an LPA1 Antagonist, in Pulmonary Fibrosis: A Phase 2 Randomized Clinical Trial. (2025) · cites this paper as [4]
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Metadata
- Authors
- Cottin, V., Koschel, D., Günther, A., Albera, C., Azuma, A., Sköld, C. M., Tomassetti, S., Hormel, P., Stauffer, J. L., Strombom, I., Kirchgaessler, K.-U., & Maher, T. M.
- Affiliations
- Lyon 1 Université (FR)
- Universitätsklinikum Gießen und Marburg (DE)
- University of Turin (IT)
- Nippon Medical School (JP)
- Karolinska University Hospital (SE)
- Ospedale G.B. Morgagni - L.Pierantoni (IT)
- Genentech (US)
- F. Hoffmann-La Roche AG (CH)
- Royal Brompton Hospital (GB)
- ORCID
- Venue
- ERJ Open Research
- Publisher
- European Respiratory Society (ERS)
- Published
- 2018-10
- Volume
- 4
- Issue
- 4
- Pages
- 00084-2018
- ISSN
- 2312-0541 (ISSN-L)
- PMC
- PMC6194203
- OpenAlex
- W2897924093
- Cited by
- 121
- References
- 14
- Citations by year
- 2026: 8 · 2025: 13 · 2024: 18 · 2023: 11 · 2022: 15 · 2021: 19 · 2020: 21 · 2019: 15 · 2018: 1
- FWCI
- 10.55
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by-nc
- Locations
- ERJ Open Research (publishedVersion, cc-by-nc)
- Europe PMC (PubMed Central) (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
- Florence Research (University of Florence) (submittedVersion)
- Institutional Research Information System University of Turin (University of Turin) (submittedVersion)
- Spiral (Imperial College London) (submittedVersion, other-oa)
- Funders
- F Hoffmann-La Roche, Ltd.
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Interstitial Lung Diseases and Idiopathic Pulmonary Fibrosis
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Atrial Fibrillation Management and Outcomes
- Keywords
- pirfenidone, idiopathic pulmonary fibrosis, drug safety, adverse drug reactions, serious adverse drug reactions, treatment discontinuation, photosensitivity reactions, nausea, fatigue
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