The DOI matches its Crossref record; 14 of the 14 references it cites were found in a registry or an index.
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.
Overview
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Figures
Verification
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
The source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“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]
Experimental — accuracy not yet measuredThe cited source says what the claim attributes to it.
In the citing paper
“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]
The cited source says what the claim attributes to it.
In the citing paper
“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]
The check wasn’t confident either way, so it gives no verdict — never disputed.
In the citing paper
“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]
Experimental — accuracy not yet measured
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Citations
Cites
A phase 3 trial of pirfenidone in patients with idiopathic pulmonary fibrosis.
King, T. E., Bradford, W. Z., Castro-Bernardini, S., Fagan, E. A., Glaspole, I., Glassberg, M. K., Gorina, E., Hopkins, P. M., Kardatzke, D., Lancaster, L., et al. (2014) · New England Journal of Medicine · doi:10.1056/nejmoa1402582 · Cited by 3,975
Pirfenidone in patients with idiopathic pulmonary fibrosis (CAPACITY): two randomised trials
Noble, P. W., Albera, C., Bradford, W. Z., Costabel, U., Glassberg, M. K., Kardatzke, D., King, T. E., Lancaster, L., Sahn, S. A., Szwarcberg, J., et al. (2011) · The Lancet · doi:10.1016/s0140-6736(11)60405-4 · Cited by 2,154
Self-citationRaghu, G., Rochwerg, B., Zhang, Y., Garcia, C. A. C., Azuma, A., Behr, J., Brozek, J. L., Collard, H. R., Cunningham, W., Homma, S., et al. (2015) · American Journal of Respiratory and Critical Care Medicine · doi:10.1164/rccm.201506-1063st · Cited by 1,916
Self-citationClinical course and prediction of survival in idiopathic pulmonary fibrosis
Ley, B., Collard, H. R., & King, T. E. (2011) · American Journal of Respiratory and Critical Care Medicine · doi:10.1164/rccm.201006-0894ci · Cited by 1,765
Meltzer, E. B., & Noble, P. W. (2008) · Orphanet Journal of Rare Diseases · doi:10.1186/1750-1172-3-8 · Cited by 421
Pirfenidone safety and adverse event management in idiopathic pulmonary fibrosis
Lancaster, L. H., de Andrade, J. A., Zibrak, J. D., Padilla, M. L., Albera, C., Nathan, S. D., Wijsenbeek, M. S., Stauffer, J. L., Kirchgaessler, K.-U., & Costabel, U. (2017) · European Respiratory Review · doi:10.1183/16000617.0057-2017 · Cited by 295
Self-citationGalli, J. A., Pandya, A., Vega‐Olivo, M., Dass, C. A., Zhao, H., & Criner, G. J. (2017) · Respirology · doi:10.1111/resp.13024 · Cited by 264
Beyond the Randomized Clinical Trial
Nallamothu, B. K., Hayward, R. A., & Bates, E. (2008) · Circulation · doi:10.1161/circulationaha.107.703579 · Cited by 253
Saturni, S., Bellini, F., Braido, F., Paggiaro, P., Sanduzzi, A., Scichilone, N., Santus, P. A., Morandi, L., & Papi, A. (2014) · Pulmonary Pharmacology & Therapeutics · doi:10.1016/j.pupt.2014.01.005 · Cited by 245
Hughes, G., Toellner, H., Morris, H. G., Leonard, C. T., & Chaudhuri, N. (2016) · Journal of Clinical Medicine · doi:10.3390/jcm5090078 · Cited by 171
Research works printed but not linked: 2
- Pharmaceuticals and Medical Devices Agency Japan. Pirfenidone Review Report. 2008. www.pmda.go.jp/files/000153687.pdf Date last accessed: June 4, 2018.
- Lancaster, 2017, Pirfenidone in patients aged 80 years and older with idiopathic pulmonary fibrosis (IPF): safety findings from pooled trial databases, Am J Respir Crit Care Med, 195, A5385
Cited by
Sorted by citations
Antifibrotic therapy for idiopathic pulmonary fibrosis: time to treat
Maher, T. M., & Strek, M. E. (2019) · Respiratory Research · doi:10.1186/s12931-019-1161-4 · Cited by 273
Self-citationPharmacotherapy and adjunctive treatment for idiopathic pulmonary fibrosis (IPF)
Saito, S., Alkhatib, A. L., Kolls, J. K., Kondoh, Y., & Lasky, J. A. (2019) · Journal of Thoracic Disease · doi:10.21037/jtd.2019.04.62 · Cited by 151
Molecular Mechanisms and Cellular Contribution from Lung Fibrosis to Lung Cancer Development
Samarelli, A. V., Masciale, V., Aramini, B., Coló, G. P., Tonelli, R., Marchioni, A., Bruzzi, G., Gozzi, F., Andrisani, D., Castaniere, I., et al. (2021) · International Journal of Molecular Sciences · doi:10.3390/ijms222212179 · Cited by 94
Bexotegrast in Patients with Idiopathic Pulmonary Fibrosis: The INTEGRIS-IPF Clinical Trial
Lancaster, L., Cottin, V., Ramaswamy, M., Wuyts, W. A., Jenkins, R. G., Scholand, M. B., Kreuter, M., Valenzuela, C., Ryerson, C. J., Goldin, J., et al. (2024) · American Journal of Respiratory and Critical Care Medicine · doi:10.1164/rccm.202403-0636oc · Cited by 80
Self-citationJustet, A., Klay, D., Porcher, R., Cottin, V., Ahmad, K., Molina‐Molina, M., Nunès, H., Reynaud‐Gaubert, M., Naccache, J. M., Manali, E. D., et al. (2020) · European Respiratory Journal · doi:10.1183/13993003.03198-2020 · Cited by 80
Self-citation
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
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
