Observational studyAnnals of the rheumatic diseases2018
Patterns and predictors of skin score change in early diffuse systemic sclerosis from the European Scleroderma Observational Study.
Observational study in Annals of the rheumatic diseases, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02339441 (Treatment Outcome in Early Diffuse Cutaneous Systemic Sclerosis), which is not on this map. Cited by 41 papers.
What it found
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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.
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.
Treatment Outcome in Early Diffuse Cutaneous Systemic Sclerosis
Who cites it
41 citing papers in PubMed.
- Biomarker analysis from the phase 2b randomized placebo-controlled trial of riociguat in early diffuse cutaneous systemic sclerosis.Rheumatology (Oxford, England) · 2024Trial
- Riociguat in patients with early diffuse cutaneous systemic sclerosis (RISE-SSc): randomised, double-blind, placebo-controlled multicentre trial.Annals of the rheumatic diseases · 2020Trial
- Abatacept in Early Diffuse Cutaneous Systemic Sclerosis: Results of a Phase II Investigator-Initiated, Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial.Arthritis & rheumatology (Hoboken, N.J.) · 2020Trial
- Shear Wave Elastography for Non-Invasive Assessment of Skin Involvement in Systemic Sclerosis.Diagnostics (Basel, Switzerland) · 2026Article
- Available Biomarkers for Personalized Prognostication in Early and Very Early Systemic Sclerosis: A Narrative Review of the Current Literature.Journal of personalized medicine · 2026Review
- Association of Type III and Type VI Collagen Neoepitopes With Disease Severity in Systemic Sclerosis.The Journal of rheumatology · 2026Article
- Skin Biopsies Enhance Prediction of Clinical Trajectory in Diffuse Cutaneous Systemic Sclerosis.Arthritis & rheumatology (Hoboken, N.J.) · 2026Article
- Systemic sclerosis: pathogenic mechanisms and their implications for treatment.Seminars in immunopathology · 2025Review
- Hand Swelling and Other Non-Raynaud Phenomenon Symptoms as the Initial Presentation of Systemic Sclerosis: Prevalence and Clinical Associations in Two US Cohorts.Arthritis & rheumatology (Hoboken, N.J.) · 2025Article
- Comparative Efficacy of Immunosuppressive Therapies in the Treatment of Diffuse Cutaneous Systemic Sclerosis.ACR open rheumatology · 2025Article
- An international perspective on the future of systemic sclerosis research.Nature reviews. Rheumatology · 2025Review
- Impact of Scleroderma-Associated Autoantibodies on Clinical Outcome Assessments: Post Hoc Analysis From a Randomised, Double-blind, Placebo-controlled, Phase 3 Trial of Tocilizumab in Scleroderma.ACR open rheumatology · 2025Article
- Abnormal Esophageal Scintigraphy Associates With a Distinct Clinical Phenotype in Patients With Systemic Sclerosis.ACR open rheumatology · 2025Article
- Prediction of Disease Progression and Clinical Response in Systemic Sclerosis: Experience From a Proof-of-Concept Trial.ACR open rheumatology · 2024Article
- Single-cell analysis reveals key differences between early-stage and late-stage systemic sclerosis skin across autoantibody subgroups.Annals of the rheumatic diseases · 2023Article
- Retrospective comparative study of the efficacy of JAK inhibitor (tofacitinib) in the treatment of systemic sclerosis-associated interstitial lung disease.Clinical rheumatology · 2023Article
- Systemic Sclerosis-Specific Antibodies: Novel and Classical Biomarkers.Clinical reviews in allergy & immunology · 2023Article
- A data-driven approach finds RNA polymerase III antibody and tendon friction rubs as enrichment tools for early diffuse scleroderma trials.Rheumatology (Oxford, England) · 2023Article
- State-of-the-art evidence in the treatment of systemic sclerosis.Nature reviews. Rheumatology · 2023Review
- Review
Corrections and comments
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Authors and funding
65 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesOur aim was to use the opportunity provided by the European Scleroderma Observational Study to (1) identify and describe those patients with early diffuse cutaneous systemic sclerosis (dcSSc) with progressive skin thickness, and (2) derive prediction models for progression over 12 months, to inform future randomised controlled trials (RCTs).
methodsThe modified Rodnan skin score (mRSS) was recorded every 3 months in 326 patients. 'Progressors' were defined as those experiencing a 5-unit and 25% increase in mRSS score over 12 months (±3 months). Logistic models were fitted to predict progression and, using receiver operating characteristic (ROC) curves, were compared on the basis of the area under curve (AUC), accuracy and positive predictive value (PPV).
results66 patients (22.5%) progressed, 227 (77.5%) did not (33 could not have their status assessed due to insufficient data). Progressors had shorter disease duration (median 8.1 vs 12.6 months, P=0.001) and lower mRSS (median 19 vs 21 units, P=0.030) than non-progressors. Skin score was highest, and peaked earliest, in the anti-RNA polymerase III (Pol3+) subgroup (n=50). A first predictive model (including mRSS, duration of skin thickening and their interaction) had an accuracy of 60.9%, AUC of 0.666 and PPV of 33.8%. By adding a variable for Pol3 positivity, the model reached an accuracy of 71%, AUC of 0.711 and PPV of 41%.
conclusionsTwo prediction models for progressive skin thickening were derived, for use both in clinical practice and for cohort enrichment in RCTs. These models will inform recruitment into the many clinical trials of dcSSc projected for the coming years. TRIAL REGISTRATION NUMBER: NCT02339441.
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