Trial reportRheumatology (Oxford, England)2024
Prognostic and predictive markers of systemic sclerosis-associated interstitial lung disease in a clinical trial and long-term observational cohort.
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 trial NCT02453256 (A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of Tocilizumab Versus Placebo in Patients With Systemic Sclerosis), which is not on this map. Cited by 26 papers, 2 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.
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of Tocilizumab Versus Placebo in Patients With Systemic Sclerosis
Who cites it
26 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Incidence and influencing factors of progressive pulmonary fibrosis in connective tissue disease-associated interstitial lung disease: a systematic review and meta-analysis.Frontiers in immunology · 2026Pooled it
- Pooled it
- Treatment Response Biomarkers for Systemic Sclerosis-Associated Interstitial Lung Disease.Arthritis care & research · 2025Trial
- Tocilizumab for severe and refractory mucous membrane pemphigoid.Journal of the European Academy of Dermatology and Venereology : JEADV · 2026Article
- Recent Advances in Biomarkers of Systemic Sclerosis-Associated Interstitial Lung Disease: Clinical Relevance and Therapeutic Perspectives.Life (Basel, Switzerland) · 2026Review
- Review
- Unlocking multi-institutional insights into disease progression with PEAL as a lossless, one-shot federated learning solution.NPJ digital medicine · 2026Article
- Safety and effectiveness of tocilizumab in systemic sclerosis: a multicentre French-Italian study.RMD open · 2026Article
- Performance of Circulating Inflammatory Biomarkers and Krebs von den Lungen 6 for Predicting Progressive Pulmonary Fibrosis in Patients With Systemic Sclerosis-Associated Interstitial Lung Disease.ACR open rheumatology · 2026Article
- First-Line Tocilizumab Monotherapy for Juvenile Systemic Sclerosis With Interstitial Lung Disease: A Case Report.Case reports in rheumatology · 2026Article
- 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
- Tocilizumab and rituximab for systemic sclerosis interstitial lung disease: a real-world cohort analysis.Rheumatology (Oxford, England) · 2025Article
- Oesophageal dysmotility patterns are associated with distinct clinical phenotypes and prognosis in patients with systemic sclerosis.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
- Autoantibodies in systemic sclerosis: From disease bystanders to pathogenic players.Journal of translational autoimmunity · 2025Review
- One-year mortality risk prediction model for patients with interstitial lung disease and lung cancer.Translational lung cancer research · 2025Article
- Sex Bias in Systemic Sclerosis: from Clinical to Immunological Differences.Clinical reviews in allergy & immunology · 2025Review
- Serum inflammatory markers as predictors of therapeutic response in non-idiopathic pulmonary fibrosis fibrotic interstitial lung disease: a retrospective cohort analysis.BMC pulmonary medicine · 2025Article
- Influence of metabolic factors on systemic sclerosis complicated with severe interstitial lung disease based on high-resolution computed tomography grading.Clinical rheumatology · 2025Article
- Characterization of Incident Interstitial Lung Disease in Late Systemic Sclerosis.Arthritis & rheumatology (Hoboken, N.J.) · 2025Article
Corrections and comments
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Authors and funding
11 authors.
Funding
Abstract
objectivesTo explore prognostic and predictive markers of SSc-associated interstitial lung disease (SSc-ILD) outcomes in a phase 3 trial (focuSSced) and prognostic markers in a real-world cohort (SMART).
methodsThe focuSSced SSc-ILD subgroup included 68 of 106 placebo-treated and 68 of 104 tocilizumab-treated patients. The SMART cohort included 505 patients with SSc-ILD. Linear mixed-effect models were used to identify factors associated with change in forced vital capacity (FVC). Kaplan-Meier estimation and Cox regression were used for time-to-event analyses.
resultsIn placebo-treated focuSSced patients, sex was a significant prognostic factor for FVC decline; males had increased risk for absolute decline ≥10% in percent-predicted FVC (ppFVC) and 0.22% faster weekly FVC decline than females (P = 0.0001). FVC was 9.8% lower in patients with CRP >6 mg/ml vs those with CRP ≤6 mg/ml (P = 0.0059). Tocilizumab reduced the risk for ≥10% decline in ppFVC in patients who were male, had earlier disease (<2 years duration), had IL-6 levels <10 pg/ml, or had anti-topoisomerase antibodies (ATA). In the SMART cohort, prognostic factors for ppFVC <70% were male sex, ATA, and low baseline FVC. Males had 3.3% lower FVC 1 year after disease onset (P < 0.001) and 0.6% faster yearly decline (P = 0.03) than females.
conclusionPrognostic markers in SSc-ILD were similar between focuSSced and SMART. Male sex and inflammatory markers were associated with lower FVC but IL-6 ≥10 pg/ml was not predictive of response to tocilizumab.
trial registrationClinicalTrials.gov: NCT02453256.
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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.