Evidence map›Paper›PMID 36111858›Full record

Trial reportRheumatology (Oxford, England)2023

Extent of fibrosis and lung function decline in patients with systemic sclerosis and interstitial lung disease: data from the SENSCIS trial.

Christopher P Denton, Nicole S Goh, Stephen M Humphries, Toby M Maher, Robert Spiera, Anand Devaraj, Lawrence Ho, Christian Stock, Elvira Erhardt, Margarida Alves and 1 more

Registry-linked trialAbstract readClinical Trial
In one paragraph

Trial report in Rheumatology (Oxford, England), 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02597933 (A Double Blind, Randomised, Placebo-controlled Trial Evaluating Efficacy and Safety of Oral Nintedanib Treatment for at Least 52 Weeks in Patients With Systemic Sclerosis Associated Interstitial Lung Disease), which is not on this map. Cited by 22 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 2 pooled it
–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.

NCT02597933 phase3completednot on this map

A Double Blind, Randomised, Placebo-controlled Trial Evaluating Efficacy and Safety of Oral Nintedanib Treatment for at Least 52 Weeks in Patients With Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD)

TypeinterventionalSponsorBoehringer IngelheimRan2015 to 2018Enrolled580ConditionsScleroderma, SystemicArmsNintedanib, Placebo
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Guideline
  2. Pooled it
  3. Article
  4. Article
  5. Article
  6. Exploratory evaluation of earlyEuropean journal of nuclear medicine and molecular imaging · 2026
    Article
  7. Proceedings of the 2Mediterranean journal of rheumatology · 2026
    Article
  8. Associations with, and predictors of, progression in systemic sclerosis-related interstitial lung disease: a scoping literature review.European respiratory review : an official journal of the European Respiratory Society · 2026
    Article
  9. Article
  10. Review
  11. Review
  12. Review
  13. Article
  14. Article
  15. Review
  16. Article
  17. Article
  18. Review
  19. Article
  20. 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

11 authors.

Christopher P DentonCentre for Rheumatology and Connective Tissue Diseases, University College London Division of Medicine, London, UK.ORCID 0000-0003-3975-8938
Nicole S GohRespiratory and Sleep Medicine, Austin Health, and Institute for Breathing and Sleep, Melbourne, VIC, Australia.
Stephen M HumphriesDepartment of Radiology, National Jewish Health, Denver, CO, USA.
Toby M MaherNational Heart and Lung Institute, Imperial College London, London, UK.
Robert SpieraDivision of Rheumatology, Hospital for Special Surgery, New York, NY, USA.
Anand DevarajDepartment of Radiology, Royal Brompton Hospital and National Heart and Lung Institute, Imperial College London, London, UK.
Lawrence HoCenter for Interstitial Lung Diseases, University of Washington, Seattle, WA, USA.
Christian StockBoehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany.
Elvira Erhardtmainanalytics GmbH, Sulzbach, Germany.
Margarida AlvesBoehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.
Athol U WellsNational Institute for Health Research Respiratory Biomedical Research Unit, Royal Brompton and Harefield NHS Foundation Trust, and National Heart and Lung Institute, Imperial College London, London, UK.

Funding

Versus Arthritis 20719
6 · The paper itself

Abstract

objectiveTo assess associations between the extent of fibrotic interstitial lung disease (ILD) and forced vital capacity (FVC) at baseline and change in FVC over 52 weeks in patients with systemic sclerosis-associated ILD (SSc-ILD) in the SENSCIS trial. MATERIAL AND

methodsWe used generalized additive models, which involve few assumptions and allow for interaction between non-linear effects, to assess associations between the extent of fibrotic ILD on high-resolution computed tomography (HRCT), and the interplay of extent of fibrotic ILD on HRCT and FVC % predicted, at baseline and FVC decline over 52 weeks.

resultsIn the placebo group (n = 288), there was weak evidence of a modest association between a greater extent of fibrotic ILD at baseline and a greater decline in FVC % predicted at week 52 [r: -0.09 (95% CI -0.2, 0.03)]. Higher values of both the extent of fibrotic ILD and FVC % predicted at baseline tended to be associated with greater decline in FVC % predicted at week 52. In the nintedanib group (n = 288), there was no evidence of an association between the extent of fibrotic ILD at baseline and decline in FVC % predicted at week 52 [r: 0.01 (95% CI: -0.11, 0.12)] or between the interplay of extent of fibrotic ILD and FVC % predicted at baseline and decline in FVC % predicted at week 52.

conclusionsData from the SENSCIS trial suggest that patients with SSc-ILD are at risk of ILD progression and benefit from nintedanib largely irrespective of their extent of fibrotic ILD at baseline. STUDY REGISTRATION: ClinicalTrials.gov, https://clinicaltrials.gov, NCT02597933.

Indexed as

Lung Diseases, InterstitialScleroderma, SystemicDisease ProgressionFibrosisHumansLungVital Capacityautoimmune diseasespulmonary fibrosisvital capacity

Identifiers

PMID36111858
PMCPMC10152288

What OpenQuestion holds

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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.