Evidence map›Paper›PMID 40627063›Full record

Observational studyLung2025

Effectiveness of Nintedanib in Progressive Pulmonary Fibrosis Assessed by Progression Criteria: An Italian, Observational, Multicenter Study.

Michele Mondoni, Francesco Varone, Fabrizio Luppi, Paolo Cameli, Stefania Cerri, Mariangela Valentina Puci, Jacopo Cefalo, Simone Contino, Alessia Martini, Bruno Iovene and 12 more

Abstract readObservational StudyMulticenter Study
PubMed Publisher
In one paragraph

Observational study in Lung, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Journal of thoracic disease · 2026
    Article
  2. Review
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

22 authors.

Michele MondoniRespiratory Unit, ASST Santi Paolo e Carlo, Department of Health Sciences, Università degli Studi di Milano, Via A. Di Rudinì N.8, 20142, Milan, Italy. michele.mondoni@unimi.it.
Francesco VaroneFondazione Policlinico Gemelli IRCSS, Rome, Italy.
Fabrizio LuppiRespiratory Unit, Fondazione IRCCS "San Gerardo dei Tintori", Università degli Studi di Milano Bicocca, Monza, Italy.
Paolo CameliRespiratory Diseases Unit, Department of Medicine, Surgery and Neurosciences, University of Siena, Siena, Italy.
Stefania CerriRespiratory Disease Unit, University Hospital of Modena, Modena, Italy.
Mariangela Valentina PuciClinical Epidemiology and Medical Statistics Unit, Department of Medical, Surgical and Experimental Sciences, University of Sassari, Sassari, Italy.
Jacopo CefaloRespiratory Unit, ASST Santi Paolo e Carlo, Department of Health Sciences, Università degli Studi di Milano, Via A. Di Rudinì N.8, 20142, Milan, Italy.
Simone ContinoRespiratory Unit, ASST Santi Paolo e Carlo, Department of Health Sciences, Università degli Studi di Milano, Via A. Di Rudinì N.8, 20142, Milan, Italy.
Alessia MartiniFondazione Policlinico Gemelli IRCSS, Rome, Italy.
Bruno IoveneFondazione Policlinico Gemelli IRCSS, Rome, Italy.
Giacomo SgallaFondazione Policlinico Gemelli IRCSS, Rome, Italy.
Giovanni FrancoRespiratory Unit, Fondazione IRCCS "San Gerardo dei Tintori", Università degli Studi di Milano Bicocca, Monza, Italy.
Umberto ZaniniRespiratory Unit, Fondazione IRCCS "San Gerardo dei Tintori", Università degli Studi di Milano Bicocca, Monza, Italy.
Tommaso PianigianiRespiratory Diseases Unit, Department of Medicine, Surgery and Neurosciences, University of Siena, Siena, Italy.
Akter DilrobaRespiratory Diseases Unit, Department of Medicine, Surgery and Neurosciences, University of Siena, Siena, Italy.
Daniele PuggioniRespiratory Disease Unit, University Hospital of Modena, Modena, Italy.
Athina PatsouraRespiratory Disease Unit, University Hospital of Modena, Modena, Italy.
Benedetta MosoleRespiratory Unit, ASST Santi Paolo e Carlo, Department of Health Sciences, Università degli Studi di Milano, Via A. Di Rudinì N.8, 20142, Milan, Italy.
Olga TorreRespiratory Unit, ASST Santi Paolo e Carlo, Department of Health Sciences, Università degli Studi di Milano, Via A. Di Rudinì N.8, 20142, Milan, Italy.
Elena BargagliRespiratory Diseases Unit, Department of Medicine, Surgery and Neurosciences, University of Siena, Siena, Italy.
Luca RicheldiFondazione Policlinico Gemelli IRCSS, Rome, Italy.
Giovanni SotgiuClinical Epidemiology and Medical Statistics Unit, Department of Medical, Surgical and Experimental Sciences, University of Sassari, Sassari, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposePulmonary fibrosis is defined as progressive based on the combination of radiological, clinical, and functional criteria. Nintedanib can reduce the rate of lung function decline, but no data are available on its effectiveness to hamper disease progression evaluated by these criteria. The primary aim of the study was to assess the number of patients with progressive pulmonary fibrosis (PPF) who no longer meet progression criteria after one year of treatment with nintedanib.

methodsA retrospective, observational, multicenter study was carried out in Italy.

results172 patients (91 (52.9%) males) with PPF were recruited, and 135 (78.5%) completed one year of treatment. After one year, 87 (64.4%) patients no longer met INBUILD progression criteria, while 107 (79.3%) did not meet 2022 ATS/ERS/JRS/ALAT guidelines criteria. Nintedanib hampered progression regardless of inclusion criteria, radiological pattern, and etiological diagnosis. Forced vital capacity (FVC) decline was significantly higher in the 12 months before than in those of treatment (mean, SD): 2512.3 (863.2) ml vs. 2313.6 (821.9) ml; p < 0.0001; 2313.6 (821.9) vs. 2335.7 (865.1); p = 0.82). FVC decline was significantly higher in the year before than in the year of treatment regardless of radiological pattern, etiological subtypes, and respiratory function. Diarrhea (mostly mild) was the most frequent adverse event (51.7%). A permanent discontinuation of the drug was recorded in 15 (9%) patients.

conclusionNintedanib is effective and safe in patients with PPF. Besides slowing lung function decline, it hampers progression regardless of etiological diagnosis, radiological pattern, respiratory function, and baseline inclusion criteria.

Indexed as

Idiopathic Pulmonary FibrosisIndolesLungPulmonary FibrosisAgedDisease ProgressionFemaleHumansItalyMaleMiddle AgedRetrospective StudiesTreatment OutcomeVital CapacityIndolesnintedanibAntifibroticFVCNintedanibPPFProgression criteriaProgressive fibrosisUIP

Identifiers

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.