Evidence map›Paper›PMID 38608658›Full record

Trial reportPneumologie (Stuttgart, Germany)2024

Clinical course of mild-to-moderate idiopathic pulmonary fibrosis during therapy with pirfenidone: Results of the non-interventional study AERplus.

Jens Schreiber, Wolfgang Schütte, Wolfgang Koerber, Bernd Seese, Dirk Koschel, Kathrin Neuland, Christian Grohé

Registry-linked trialOpen access · hybridAbstract readClinical Trial
In one paragraph

Trial report in Pneumologie (Stuttgart, Germany), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02622477 (Clinical Course of Treatment With ESBRIET in Patients With Mild to Moderate IPF), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
1.7field-weighted citation impact, top 16% of its field
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.

NCT02622477 completednot on this map

Clinical Course of Treatment With ESBRIET in Patients With Mild to Moderate IPF

TypeobservationalSponsorHoffmann-La RocheRan2014 to 2016Enrolled12ConditionsIdiopathic Pulmonary FibrosisArmsPirfenidone
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 4 citations in OpenAlex.

  1. Patient-reported outcome measures for cough used in interstitial lung disease: a systematic review.European respiratory review : an official journal of the European Respiratory Society · 2025
    Pooled it
  2. Review
  3. Review
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

7 authors at 5 institutions in 1 country.

Jens SchreiberPneumonology, Otto-von-Guericke-Universität Magdeburg, Magdeburg, Germany.
Wolfgang SchütteKlinik für Innere Medizin II, Krankenhaus Martha-Maria Halle-Dölau, Halle, Germany.
Wolfgang KoerberAbt. Pneumologie/Beatmungsmedizin und Schlaflabor, Evangelisches Krankenhaus Göttingen-Weende gGmbH, Bovenden-Lenglern, Germany.
Bernd SeeseAbt. Pneumologie, Thoraxzentrum Bezirk Unterfranken, Münnerstadt, Germany.
Dirk KoschelInnere Medizin und Pneumologie, Fachkrankenhaus Coswig, Coswig, Germany.
Kathrin NeulandGlobal Scientific Communications, Roche Pharma AG, Grenzach-Wyhlen, Germany.
Christian GrohéKlinik für Pneumologie, Evangelische Lungenklinik Berlin, Berlin, Germany.
Evangelische Lungenklinik Berlin · DEEvangelisches Krankenhaus Göttingen-Weende · DEMartha-Maria Hospital · DEOtto-von-Guericke University Magdeburg · DERoche Pharma AG (Germany) · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPirfenidone was the first anti-fibrotic drug approved in Europe in 2011 for the treatment of mild-to-moderate idiopathic pulmonary fibrosis.

objectivesTo investigate the clinical course of mild-to-moderate idiopathic pulmonary fibrosis in pirfenidone-treated patients in a real-world setting.

methodsThe non-interventional study was conducted at 18 sites in Germany from 6/2014-12/2016. Adult patients with mild-to-moderate idiopathic pulmonary fibrosis were treated with pirfenidone (escalated from 3×1 to 3×3 capsules of 267 mg/day within 3 weeks) for 12 months. The observation period comprised 4 follow-up visits at months 3, 6, 9 and 12. Disease progression was defined as decrease of ≥10% in vital capacity or ≥15% in diffusing capacity of the lung for carbon monoxide (DL

resultsA total of 51 patients (80.4% male, mean age 70.6 years) were included in the full analysis set. Disease progression at any visit was reported for 23 (67.6%) of 34 patients with available data. Over the course of the study, lung function parameters, physical resilience, impact of cough severity on quality of life, and the mean Gender, Age and Physiology Index (stage II) remained stable. In total, 29 patients (56.9%) experienced at least one adverse drug reaction (11 patients discontinued due to adverse drug reactions); serious adverse reactions were reported in 12 patients (23.5%).

conclusionsThe results of this study are in line with the established benefit-risk profile of pirfenidone. Therefore, pirfenidone can be considered a valuable treatment option to slow disease progression in mild-to-moderate idiopathic pulmonary fibrosis. NCT02622477.

Indexed as

Drug-Related Side Effects and Adverse ReactionsIdiopathic Pulmonary FibrosisPyridonesAdultAgedCoughDisease ProgressionFemaleHumansMaleQuality of LifepirfenidonePyridones

Identifiers

PMID38608658
PMCPMC11014748
OpenAlexW4394771042

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

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.