Evidence mapPaperPMID 36796874Full record

Trial reportRMD open2023

Effect of nintedanib in patients with systemic sclerosis-associated interstitial lung disease and risk factors for rapid progression.

Dinesh Khanna, Toby M Maher, Elizabeth R Volkmann, Yannick Allanore, Vanessa Smith, Shervin Assassi, Michael Kreuter, Anna-Maria Hoffmann-Vold, Masataka Kuwana, Christian Stock and 3 more

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in RMD open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 2 pooled it
7.1field-weighted citation impact, top 3% 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

15 citing papers in PubMed, 2 syntheses or guidelines pooled it, 28 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Article
  7. Review
  8. Review
  9. Review
  10. Re-envisioning clinical trial design in systemic sclerosis.Expert review of clinical immunology · 2025
    Review
  11. Review
  12. Article
  13. Connective tissue disease-associated interstitial lung disease.Jornal brasileiro de pneumologia : publicacao oficial da Sociedade Brasileira de Pneumologia e Tisilogia · 2024
    Review
  14. Review
  15. 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

13 authors at 10 institutions in 7 countries.

Dinesh KhannaDivision of Rheumatology, Scleroderma Program, University of Michigan, Ann Arbor, Michigan, USA khannad@umich.edu.ORCID 0000-0003-1412-4453
Toby M MaherKeck School of Medicine, University of Southern California, Los Angeles, California, USA.ORCID 0000-0001-7192-9149
Elizabeth R VolkmannDivision of Rheumatology, University of California, David Geffen School of Medicine, Los Angeles, California, USA.ORCID 0000-0003-3750-6569
Yannick AllanoreDepartment of Rheumatology A, Descartes University, APHP, Cochin Hospital, Paris, France.ORCID 0000-0002-6149-0002
Vanessa SmithDepartment of Rheumatology, Ghent University Hospital, Ghent, Belgium.ORCID 0000-0001-6271-7945
Shervin AssassiDivision of Rheumatology, University of Texas McGovern Medical School, Houston, Texas, USA.ORCID 0000-0002-8059-9978
Michael KreuterCenter for Interstitial and Rare Lung Diseases, Pneumology and Respiratory Care Medicine, Thoraxklinik, University of Heidelberg and German Center for Lung Research, Heidelberg, Germany.ORCID 0000-0003-4402-2159
Anna-Maria Hoffmann-VoldInflammatory and Fibrotic Rheumatic Disease Research Area, Oslo University Hospital, Oslo, Norway.ORCID 0000-0001-6467-7422
Masataka KuwanaDepartment of Allergy and Rheumatology, Nippon Medical School Graduate School of Medicine, Tokyo, Japan.ORCID 0000-0001-8352-6136
Christian StockGlobal Biostatistics and Data Sciences, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany.ORCID 0000-0002-3493-3234
Margarida AlvesTA Inflammation Med, Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.
Steven SambevskiTA Inflammation Med, Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.
Christopher P DentonUniversity College London Division of Medicine, Centre for Rheumatology and Connective Tissue Diseases, London, UK.ORCID 0000-0003-3975-8938
Boehringer Ingelheim (Germany) · DEDélégation Paris 5 · FRGhent University Hospital · BEHeidelberg University · DENippon Medical School · JPOslo University Hospital · NOUniversity College London · GBUniversity of California, Los Angeles · USUniversity of Michigan · USUniversity of Southern California · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo investigate the rate of decline in forced vital capacity (FVC), and the effect of nintedanib on the rate of decline in FVC, in subjects with systemic sclerosis-associated interstitial lung disease (SSc-ILD) who had risk factors for rapid decline in FVC.

methodsThe SENSCIS trial enrolled subjects with SSc and fibrotic ILD of ≥10% extent on high-resolution CT. The rate of decline in FVC over 52 weeks was analysed in all subjects and in those with early SSc (<18 months since first non-Raynaud symptom), elevated inflammatory markers (C reactive protein ≥6 mg/L and/or platelets ≥330×10

resultsIn the placebo group, the rate of decline in FVC was numerically greater in subjects with <18 months since first non-Raynaud symptom (-167.8 mL/year), elevated inflammatory markers (-100.7 mL/year), mRSS 15-40 (-121.7 mL/year) or mRSS ≥18 (-131.7 mL/year) than in all subjects (-93.3 mL/year). Nintedanib reduced the rate of FVC decline across subgroups, with a numerically greater effect in patients with these risk factors for rapid FVC decline.

conclusionIn the SENSCIS trial, subjects with SSc-ILD who had early SSc, elevated inflammatory markers or extensive skin fibrosis had a more rapid decline in FVC over 52 weeks than the overall trial population. Nintedanib had a numerically greater effect in patients with these risk factors for rapid ILD progression.

Indexed as

Lung Diseases, InterstitialScleroderma, SystemicFibrosisHumansIndolesRisk FactorsIndolesnintedanibAutoimmune DiseasesPulmonary FibrosisScleroderma, SystemicTherapeutics

Identifiers

PMID36796874
PMCPMC9936273
OpenAlexW4321116107

What Socratic holds

Textmetadata
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 Socratic graph.