Evidence mapPaperPMID 35150246Full record

Trial reportRheumatology (Oxford, England)2022

Dyspnoea and cough in patients with systemic sclerosis-associated interstitial lung disease in the SENSCIS trial.

Elizabeth R Volkmann, Michael Kreuter, Anna M Hoffmann-Vold, Marlies Wijsenbeek, Vanessa Smith, Dinesh Khanna, Christopher P Denton, Wim A Wuyts, Corinna Miede, Margarida Alves and 2 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Rheumatology (Oxford, England), 2022. 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 18 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 3 pooled it
3.8field-weighted citation impact, top 6% 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
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 3 syntheses or guidelines pooled it, 28 citations in OpenAlex.

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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

12 authors at 11 institutions in 7 countries.

Elizabeth R VolkmannDepartment of Medicine, Division of Rheumatology, University of California, David Geffen School of Medicine, Los Angeles, CA, USA.ORCID 0000-0003-3750-6569
Michael KreuterCenter for Interstitial and Rare Lung Diseases, Pneumology and Respiratory Care Medicine, Thoraxklinik, University of Heidelberg, Member of the German Center for Lung Research, Heidelberg, Germany.
Anna M Hoffmann-VoldDepartment of Rheumatology, Oslo University Hospital, Oslo, Norway.ORCID 0000-0001-6467-7422
Marlies WijsenbeekDepartment of Respiratory Medicine, Erasmus MC, University Medical Centre, Rotterdam, The Netherlands.
Vanessa SmithDepartment of Rheumatology and Internal Medicine, Ghent University Hospital, Ghent, Belgium.ORCID 0000-0001-6271-7945
Dinesh KhannaDepartment of Medicine, University of Michigan, Ann Arbor, MI, USA.
Christopher P DentonUniversity College London Division of Medicine, Centre for Rheumatology and Connective Tissue Diseases, London, UK.ORCID 0000-0003-3975-8938
Wim A WuytsUnit for Interstitial Lung Diseases, Department of Pulmonary Medicine, University Hospitals Leuven, Leuven, Belgium.
Corinna Miedemainanalytics GmbH, Sulzbach (Taunus).
Margarida AlvesBoehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.
Steven SambevskiBoehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.
Yannick AllanoreDepartment of Rheumatology A, Descartes University, APHP, Cochin Hospital, Paris, France.
Boehringer Ingelheim (Germany) · DEDélégation Paris 5 · FRErasmus MC · NLGhent University Hospital · BEHeidelberg University · DEKU Leuven · BEOslo University Hospital · NOReference Institute for Bioanalytics · DEUniversity College London · GBUniversity of California, Los Angeles · USUniversity of Michigan · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe aim of these analyses was to investigate the rate of decline in forced vital capacity (FVC) in patients with SSc-associated interstitial lung disease (SSc-ILD) with and without cough or dyspnoea in the SENSCIS trial.

methodsPatients in the SENSCIS trial were randomized to receive nintedanib or placebo. Subgroups with and without cough or dyspnoea at baseline were defined by responses to the St George's Respiratory Questionnaire.

resultsAt baseline, 114/575 patients (19.8%) did not have cough and 172/574 patients (30.0%) did not have dyspnoea. In the placebo group, the rate of FVC decline over 52 weeks was similar in patients with and without cough (-95.6 and -83.4 mL/year, respectively) or dyspnoea (-95.8 and -87.7 mL/year, respectively). The effect of nintedanib vs placebo on reducing the rate of FVC decline was numerically more pronounced in patients without than with cough [difference: 74.4 (95% CI -11.1, 159.8) vs 31.5 (-11.1, 74.1)] and without than with dyspnoea [79.8 (9.8, 149.7) vs 25.7 (-19.9, 71.3)], but interaction P-values did not indicate heterogeneity in the treatment effect between these subgroups (P = 0.38 and P = 0.20, respectively).

conclusionIn the placebo group of the SENSCIS trial, the rate of FVC decline was similar irrespective of the presence of cough or dyspnoea at baseline. The effect of nintedanib on reducing the rate of FVC decline was numerically more pronounced in patients without than with cough or dyspnoea at baseline, but no statistically significant heterogeneity was observed between the subgroups.

trial registrationClinicalTrials.gov, https://clinicaltrials.gov, NCT02597933.

Indexed as

Lung Diseases, InterstitialScleroderma, SystemicCoughDisease ProgressionDyspneaHumansTreatment OutcomeVital Capacityconnective tissue diseasesnintedanibsystemic sclerodermavital capacity

Identifiers

PMID35150246
PMCPMC9629379
OpenAlexW4210849527

What Socratic 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 Socratic graph.