Trial reportArthritis and rheumatism2011
Clinical course of lung physiology in patients with scleroderma and interstitial lung disease: analysis of the Scleroderma Lung Study Placebo Group.
Trial report in Arthritis and rheumatism, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00883129 (Mycophenolate vs. Oral Cyclophosphamide in Scleroderma Interstitial Lung Disease), which is not on this map. Cited by 58 papers, 5 of them syntheses that pooled 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.
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.
Mycophenolate vs. Oral Cyclophosphamide in Scleroderma Interstitial Lung Disease (Scleroderma Lung Study II)
Who cites it
58 citing papers in PubMed, 5 syntheses or guidelines pooled it.
- 2023 American College of Rheumatology (ACR)/American College of Chest Physicians (CHEST) Guideline for the Screening and Monitoring of Interstitial Lung Disease in People with Systemic Autoimmune Rheumatic Diseases.Arthritis care & research · 2024Guideline
- 2023 American College of Rheumatology (ACR)/American College of Chest Physicians (CHEST) Guideline for the Screening and Monitoring of Interstitial Lung Disease in People with Systemic Autoimmune Rheumatic Diseases.Arthritis & rheumatology (Hoboken, N.J.) · 2024Guideline
- Computed Tomography Predictors of Mortality or Disease Progression in Systemic Sclerosis-Interstitial Lung Disease: A Systematic Review.Frontiers in medicine · 2021Pooled it
- Pulmonary function tests as outcomes for systemic sclerosis interstitial lung disease.European respiratory review : an official journal of the European Respiratory Society · 2018Pooled it
- Cyclophosphamide for connective tissue disease-associated interstitial lung disease.The Cochrane database of systematic reviews · 2018Pooled it
- Extent of fibrosis and lung function decline in patients with systemic sclerosis and interstitial lung disease: data from the SENSCIS trial.Rheumatology (Oxford, England) · 2023Trial
- Novel Therapeutic Approaches for Pulmonary Manifestations of Systemic Sclerosis.American journal of respiratory and critical care medicine · 2020Trial
- Performance of a new quantitative computed tomography index for interstitial lung disease assessment in systemic sclerosis.Scientific reports · 2019Trial
- Longitudinal Changes in Quantitative Interstitial Lung Disease on Computed Tomography after Immunosuppression in the Scleroderma Lung Study II.Annals of the American Thoracic Society · 2018Trial
- Predictors of lung function decline in scleroderma-related interstitial lung disease based on high-resolution computed tomography: implications for cohort enrichment in systemic sclerosis-associated interstitial lung disease trials.Arthritis research & therapy · 2015Trial
- 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 · 2026Article
- Non-contiguous computed tomography lung scans can be manipulated to permit artificial intelligence analyses for interstitial lung disease in systemic sclerosis.Biology methods & protocols · 2026Article
- The importance of considering progression speed in systemic sclerosis-associated interstitial lung diseases: application of 2022 and 2024 clinical practice guidelines for progressive pulmonary fibrosis, a retrospective cohort study.Respiratory research · 2025Article
- Predicting trajectories of lung function decline in systemic sclerosis-related interstitial lung disease.Rheumatology (Oxford, England) · 2025Article
- Diagnostics, Efficacy, and Safety of Immunomodulatory and Anti-Fibrotic Treatment for Interstitial Lung Disease Associated with Systemic Scleroderma (SSc-ILD).Diagnostics (Basel, Switzerland) · 2025Review
- Characterization of Incident Interstitial Lung Disease in Late Systemic Sclerosis.Arthritis & rheumatology (Hoboken, N.J.) · 2025Article
- 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
- Risk factors for lung function decline in systemic sclerosis-associated interstitial lung disease in a large single-centre cohort.Rheumatology (Oxford, England) · 2023Article
- Clinically Relevant Biomarkers in Connective Tissue Disease-Associated Interstitial Lung Disease.Immunology and allergy clinics of North America · 2023Review
- Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
Abstract
objectivePatients with systemic sclerosis-associated interstitial lung disease (SSc-ILD) are thought to have the greatest decline in lung function (forced vital capacity [FVC]% predicted) in the early years after disease onset. The aim of this study was to assess the natural history of the decline in FVC% predicted in patients receiving placebo in the Scleroderma Lung Study and to evaluate possible factors for cohort enrichment in future therapeutic trials.
methodsPatients randomized to receive placebo (n=79) were divided into 3 groups based on the duration of SSc (0-2 years, 2-4 years, and >4 years). Descriptive statistics and a mixed-effects model were used to analyze the rate of decline in the FVC% predicted over a 1-year period. Additional analyses stratified according to the severity of fibrosis on high-resolution computed tomography (HRCT) were performed, and interactions between disease severity and disease duration were explored.
resultsThe mean±SD decline in the unadjusted FVC% predicted during the 1-year period was 4.2±12.8%. At baseline, 28.5%, 43.0%, and 28.5% of patients were in the groups with disease durations of 0-2 years, 2-4 years, and >4 years, respectively. The rate of decline in the FVC% predicted was not significantly different across the 3 disease groups (P=0.85). When stratified by baseline fibrosis on HRCT, the rate of decline in the FVC% predicted was statistically significantly greater in the group with severe fibrosis (mean annualized decline in the FVC% predicted 7.2% versus 2.7% in the groups with no or moderate fibrosis; P=0.008). The decline observed in the group with severe fibrosis was most pronounced in those with a relatively short disease duration (0-2 years; annualized decline 7.0%).
conclusionAmong patients with SSc-ILD in the Scleroderma Lung Study, the rates of progression of lung disease were similar irrespective of disease duration. The baseline HRCT fibrosis score is a predictor of a future decline in the FVC% predicted in the absence of effective treatment.
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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.