Evidence map›Paper›PMID 37294870›Full record

Trial reportRheumatology (Oxford, England)2024

Effects of nintedanib in patients with limited cutaneous systemic sclerosis and interstitial lung disease.

Yannick Allanore, Dinesh Khanna, Vanessa Smith, Martin Aringer, Anna-Maria Hoffmann-Vold, Masataka Kuwana, Peter A Merkel, Christian Stock, Steven Sambevski, Christopher P Denton and 1 more

2 registry-linked trialsOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Rheumatology (Oxford, England), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
3.1field-weighted citation impact, top 9% 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.

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
NCT03313180 phase3completednot on this map

An Open-label Extension Trial of the Long Term Safety of Nintedanib in Patients With 'Systemic Sclerosis Associated Interstitial Lung Disease' (SSc-ILD)

TypeinterventionalSponsorBoehringer IngelheimRan2017 to 2023Enrolled444ConditionsLung Diseases, InterstitialArmsNintedanib
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Combination antifibrotic and immunosuppressive therapy in progressive fibrosing ILD.Sarcoidosis, vasculitis, and diffuse lung diseases : official journal of WASOG · 2026
    Article
  5. Review
  6. Review
  7. Review
  8. 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 at 12 institutions in 9 countries.

Yannick AllanoreDepartment of Rheumatology, Paris Cité University, APHP, Cochin Hospital, Paris, France.
Dinesh KhannaDepartment of Medicine, University of Michigan, Ann Arbor, MI, USA.ORCID 0000-0003-1412-4453
Vanessa SmithDepartment of Rheumatology and Internal Medicine, Ghent University Hospital and Unit for Molecular Immunology and Inflammation, VIB Inflammation Research Center (IRC), Ghent, Belgium.ORCID 0000-0001-6271-7945
Martin AringerDivision of Rheumatology, Department of Medicine III, University Medical Center and Faculty of Medicine Carl Gustav Carus, Dresden, Dresden, TU, Germany.ORCID 0000-0003-4471-8375
Anna-Maria Hoffmann-VoldDepartment of Rheumatology, 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
Peter A MerkelDivision of Rheumatology, Department of Medicine, Division of Epidemiology, Department of Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia, PA, USA.
Christian StockBoehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.
Steven SambevskiBoehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.
Christopher P DentonDivision of Medicine, Centre for Rheumatology and Connective Tissue Diseases, University College London, London, UK.ORCID 0000-0003-3975-8938
SENSCIS Trial Investigators
University College London · GBBoehringer Ingelheim (Germany) · DEUniversité Paris Cité · FRUniversity of Pennsylvania · USNippon Medical School · JPOslo University Hospital · NOUniversity Medical Center · USGhent University Hospital · BEUniversity of Michigan · USTissue Dynamics (Israel) · ILUniversity Hospital Carl Gustav Carus · DEVIB-UGent Center for Inflammation Research · BE

Funding

Boehringer Ingelheim International GmbH
6 · The paper itself

Abstract

objectivesTo investigate the course of interstitial lung disease (ILD) and the effects of nintedanib in patients with limited cutaneous systemic sclerosis (lcSSc).

methodsIn the SENSCIS trial, patients with SSc-ILD were randomized to receive nintedanib or placebo. Patients who completed the SENSCIS trial were eligible to enter SENSCIS-ON, in which all patients received open-label nintedanib.

resultsAmong 277 patients with lcSSc treated in the SENSCIS trial, the rate (s.e.) of decline in forced vital capacity (FVC; ml/year) over 52 weeks was -74.5 (19.2) in the placebo group and -49.1 (19.8) in the nintedanib group (difference: 25.3 [95% CI -28.9, 79.6]). Among 249 patients with data at week 52, mean (s.e.) change in FVC at week 52 was -86.4 (21.1) ml in the placebo group and -39.1 (22.2) ml in the nintedanib group. Among 183 patients with lcSSc who participated in SENSCIS-ON and had data at week 52, mean (s.e.) change in FVC from baseline to week 52 of SENSCIS-ON was -41.5 (24.0) ml in patients who took placebo in the SENSCIS trial and initiated nintedanib in SENSCIS-ON and -45.1 (19.1) ml in patients who took nintedanib in the SENSCIS trial and continued it in SENSCIS-ON.

conclusionPatients with lcSSc may develop progressive fibrosing ILD. By targeting pulmonary fibrosis, nintedanib slows decline in lung function in patients with lcSSc and ILD.

trial registrationClinicalTrials.gov (https://clinicaltrials.gov), NCT02597933 and NCT03313180.

Indexed as

Lung Diseases, InterstitialPulmonary FibrosisScleroderma, SystemicHumansIndolesIndolesnintedanibantifibrotic agentspulmonary fibrosispulmonary function testssclerodermasystemic

Identifiers

PMID37294870
PMCPMC10907814
OpenAlexW4379980608

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.