Evidence map›Paper›PMID 35199968›Full record

Trial reportArthritis & rheumatology (Hoboken, N.J.)2022

Nintedanib in Patients With Autoimmune Disease-Related Progressive Fibrosing Interstitial Lung Diseases: Subgroup Analysis of the INBUILD Trial.

Eric L Matteson, Clive Kelly, Jörg H W Distler, Anna-Maria Hoffmann-Vold, James R Seibold, Shikha Mittoo, Paul F Dellaripa, Martin Aringer, Janet Pope, Oliver Distler and 6 more

Open access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Arthritis & rheumatology (Hoboken, N.J.), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 67 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
67citing papers in PubMed, 6 pooled it
15.4field-weighted citation impact, top 1% 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.

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

67 citing papers in PubMed, 6 syntheses or guidelines pooled it, 105 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Review
  8. Article
  9. Review
  10. Review
  11. Combination antifibrotic and immunosuppressive therapy in progressive fibrosing ILD.Sarcoidosis, vasculitis, and diffuse lung diseases : official journal of WASOG · 2026
    Article
  12. Article
  13. Article
  14. Review
  15. Article
  16. Pulmonary Involvement in Autoimmune-Mediated Disease.Deutsches Arzteblatt international · 2025
    Review
  17. Article
  18. Article
  19. Article
  20. Article

7 more citing papers are in PubMed but not listed here.

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

16 authors at 14 institutions in 6 countries.

Eric L MattesonMayo Clinic College of Medicine and Science, Rochester, Minnesota.ORCID 0000-0002-9866-0124
Clive KellyNewcastle University, Newcastle-upon-Tyne, UK.
Jörg H W DistlerFriedrich-Alexander University Erlangen-Nuremberg, Erlangen, Germany.ORCID 0000-0001-7408-9333
Anna-Maria Hoffmann-VoldOslo University Hospital, Oslo, Norway.
James R SeiboldScleroderma Research Consultants LLC, Aiken, South Carolina.
Shikha MittooUniversity of Toronto, Toronto, Ontario, Canada.
Paul F DellaripaBrigham and Women's Hospital, Boston, Massachusetts.
Martin AringerTechnical University of Dresden, Dresden, Germany.ORCID 0000-0003-4471-8375
Janet PopeUniversity of Western Ontario, London, Ontario, Canada.ORCID 0000-0003-1479-5302
Oliver DistlerUniversity of Zurich, Zurich, Switzerland.ORCID 0000-0002-0546-8310
Alexandra Jameselderbrook solutions GmbH, Bietigheim-Bissingen, Germany.
Rozsa Schlenker-HercegBoehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, Connecticut.
Susanne StowasserBoehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.
Manuel QuaresmaBoehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.
Kevin R FlahertyUniversity of Michigan, Ann Arbor.
INBUILD Trial Investigators
Boehringer Ingelheim (Germany) · DEBoehringer Ingelheim (United States) · USBrigham and Women's Hospital · USFachverband Gebäude-Klima (Germany) · DEFriedrich-Alexander-Universität Erlangen-Nürnberg · DEMayo Clinic · USNewcastle University · GBOslo University Hospital · NOTechnische Universität Dresden · DEUniversity of Michigan · USUniversity of South Carolina Aiken · USUniversity of Toronto · CAUniversity of Zurich · CHWestern University · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo analyze the efficacy and safety of nintedanib in patients with fibrosing autoimmune disease-related interstitial lung diseases (ILDs) with a progressive phenotype.

methodsThe INBUILD trial enrolled patients with a fibrosing ILD other than idiopathic pulmonary fibrosis, with diffuse fibrosing lung disease of >10% extent on high-resolution computed tomography, forced vital capacity percent predicted (FVC%) ≥45%, and diffusing capacity of the lungs for carbon monoxide percent predicted ≥30% to <80%. Patients fulfilled protocol-defined criteria for progression of ILD within the 24 months before screening, despite management deemed appropriate in clinical practice. Subjects were randomized to receive nintedanib or placebo. We assessed the rate of decline in FVC (ml/year) and adverse events (AEs) over 52 weeks in the subgroup with autoimmune disease-related ILDs.

resultsAmong 170 patients with autoimmune disease-related ILDs, the rate of decline in FVC over 52 weeks was -75.9 ml/year with nintedanib versus -178.6 ml/year with placebo (difference 102.7 ml/year [95% confidence interval 23.2, 182.2]; nominal P = 0.012). No heterogeneity was detected in the effect of nintedanib versus placebo across subgroups based on ILD diagnosis (P = 0.91). The most frequent AE was diarrhea, reported in 63.4% and 27.3% of subjects in the nintedanib and placebo groups, respectively. AEs led to permanent discontinuation of trial drug in 17.1% and 10.2% of subjects in the nintedanib and placebo groups, respectively.

conclusionIn the INBUILD trial, nintedanib slowed the rate of decline in FVC in patients with progressive fibrosing autoimmune disease-related ILDs, with AEs that were manageable for most patients.

Indexed as

Autoimmune DiseasesIdiopathic Pulmonary FibrosisLung Diseases, InterstitialDisease ProgressionHumansIndolesProtein Kinase InhibitorsVital CapacityIndolesnintedanibProtein Kinase Inhibitors

Identifiers

PMID35199968
PMCPMC9321107
OpenAlexW4213418035

What OpenQuestion holds

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LicenceCC BY-NC
Read underepoch 390

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.