Evidence map›Paper›PMID 41107055›Full record

Trial reportRMD open2025

Nailfold capillaroscopy in patients with systemic sclerosis-associated interstitial lung disease: a substudy of the SENSCIS trial.

Vanessa Smith, Christopher P Denton, Ariane L Herrick, Carina Ittrich, Margarida Alves, Maurizio Cutolo

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in RMD open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Review
  2. Review
  3. 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

6 authors.

Vanessa SmithGhent University Hospital, Department of Rheumatology, Ghent University, Department of Internal Medicine and Unit for Molecular Immunology and Inflammation, VIB Inflammation Research Centre (IRC), Ghent, Belgium vanessa.smith@ugent.be.ORCID 0000-0001-6271-7945
Christopher P DentonCentre for Rheumatology and Connective Tissue Diseases, University College London Division of Medicine, London, UK.
Ariane L HerrickCentre for Musculoskeletal Research, The University of Manchester, Northern Care Alliance NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK, and National Institute for Health and Care Research (NIHR) Manchester Biomedical Research Centre (BRC), Manchester, UK.ORCID 0000-0003-4941-7926
Carina IttrichBoehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany.
Margarida AlvesBoehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.
Maurizio CutoloLaboratory of Experimental Rheumatology, Division of Rheumatology, Department of Internal Medicine, University of Genova, IRCCS San Martino Polyclinic, Genova, Italy.ORCID 0000-0002-5396-0932

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo assess microvascular changes in nailfold capillaries in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD) who received nintedanib or placebo in a sub-study of the SENSCIS trial.

methodsNailfold capillaroscopy (NC) was performed at baseline and week 52. In the nintedanib and placebo groups, we measured capillary density (number of capillaries/mm), giant capillaries, abnormal shapes and percentage of fingers with microhaemorrhages. In addition, capillary density was evaluated in patients who did/did not have risk factors for rapid forced vital capacity (FVC) decline at baseline and who did/did not have ILD progression (absolute decline in FVC % predicted >5% or death) from baseline to week 52.

resultsBetween baseline and week 52, no notable changes were observed in any NC measurement in the overall placebo or nintedanib groups. In patients with risk factors for rapid FVC decline (n=38), there was a numerical reduction in mean capillary density over 52 weeks with placebo, but it remained stable with nintedanib. Among patients who had ILD progression (n=11), there was a numerical increase in mean capillary density over 52 weeks with nintedanib, but it remained stable with placebo. There were no notable changes in capillary density among patients who did not have risk factors for rapid FVC decline at baseline or ILD progression at week 52.

conclusionIn a substudy of the SENSCIS trial, numerical differences in changes in capillary density assessed by NC over 52 weeks may suggest a potential effect of nintedanib in patients at risk of ILD progression.

Indexed as

Lung Diseases, InterstitialMicroscopic AngioscopyNailsScleroderma, SystemicAdultAgedCapillariesDisease ProgressionFemaleHumansIndolesMaleMiddle AgedVital CapacityIndolesnintedanibAutoimmune DiseasesClinical TrialLung Diseases, InterstitialScleroderma, SystemicTreatment

Identifiers

PMID41107055
PMCPMC12542725

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Registered trials

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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.