Trial reportArthritis & rheumatology (Hoboken, N.J.)2020
Abatacept in Early Diffuse Cutaneous Systemic Sclerosis: Results of a Phase II Investigator-Initiated, Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial.
Trial report in Arthritis & rheumatology (Hoboken, N.J.), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04922736 (Patient Reported Outcomes With UVA-1 Therapy for Treatment of Sclerosing Skin Diseases), which is not on this map. Cited by 113 papers, 6 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.
Patient Reported Outcomes With UVA-1 Therapy for Treatment of Sclerosing Skin Diseases
Who cites it
113 citing papers in PubMed, 6 syntheses or guidelines pooled it, 220 citations in OpenAlex.
- Efficacy of different pharmacological therapies for diffuse cutaneous systemic sclerosis: a systematic review and network meta-analysis.European journal of clinical pharmacology · 2026Pooled it
- 2023 Brazilian Society of Rheumatology guidelines for the treatment of systemic sclerosis.Advances in rheumatology (London, England) · 2024Guideline
- Impact of Innovative Treatment Using Biological Drugs for the Modulation of Diffuse Cutaneous Systemic Sclerosis: A Systematic Review.Medicina (Kaunas, Lithuania) · 2023Pooled it
- A genomic meta-analysis of clinical variables and their association with intrinsic molecular subsets in systemic sclerosis.Rheumatology (Oxford, England) · 2022Pooled it
- Pooled it
- An update on targeted therapies in systemic sclerosis based on a systematic review from the last 3 years.Arthritis research & therapy · 2021Pooled it
- Belumosudil in diffuse cutaneous systemic sclerosis: a randomized, double-blind, open-label extension, placebo-controlled, phase 2 study.Rheumatology (Oxford, England) · 2025Trial
- Effects of nintedanib in patients with limited cutaneous systemic sclerosis and interstitial lung disease.Rheumatology (Oxford, England) · 2024Trial
- Prognostic and predictive markers of systemic sclerosis-associated interstitial lung disease in a clinical trial and long-term observational cohort.Rheumatology (Oxford, England) · 2024Trial
- Effect of nintedanib in patients with systemic sclerosis-associated interstitial lung disease and risk factors for rapid progression.RMD open · 2023Trial
- Clinical and Molecular Findings After Autologous Stem Cell Transplantation or Cyclophosphamide for Scleroderma: Handling Missing Longitudinal Data.Arthritis care & research · 2023Trial
- Machine-learning classification identifies patients with early systemic sclerosis as abatacept responders via CD28 pathway modulation.JCI insight · 2022Trial
- Tofacitinib in the treatment of skin and musculoskeletal involvement in patients with systemic sclerosis, evaluated by ultrasound.Rheumatology international · 2021Trial
- A randomised, double-blind, placebo-controlled, 24-week, phase II, proof-of-concept study of romilkimab (SAR156597) in early diffuse cutaneous systemic sclerosis.Annals of the rheumatic diseases · 2020Trial
- Riociguat in patients with early diffuse cutaneous systemic sclerosis (RISE-SSc): randomised, double-blind, placebo-controlled multicentre trial.Annals of the rheumatic diseases · 2020Trial
- Skin Biopsies Enhance Prediction of Clinical Trajectory in Diffuse Cutaneous Systemic Sclerosis.Arthritis & rheumatology (Hoboken, N.J.) · 2026Article
- The immune landscape of systemic sclerosis: from pathogenic mechanisms to precision therapeutic breakthroughs.Frontiers in immunology · 2026Review
- Systemic sclerosis: pathogenic mechanisms and their implications for treatment.Seminars in immunopathology · 2025Review
- Harnessing artificial intelligence to advance insights in systemic sclerosis skin and lung disease.Current opinion in rheumatology · 2025Review
- Fibrotic Disease of the Skin and Lung: Shared Pathways, Environmental Drivers, and Therapeutic Opportunities in a Changing Climate.International journal of molecular sciences · 2025Review
53 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
39 authors at 20 institutions in 6 countries.
Funding
Abstract
objectiveT cells play a key role in the pathogenesis of early systemic sclerosis. This study was undertaken to assess the safety and efficacy of abatacept in patients with diffuse cutaneous systemic sclerosis (dcSSc).
methodsIn this 12-month, randomized, double-blind, placebo-controlled trial, participants were randomized 1:1 to receive either subcutaneous abatacept 125 mg or matching placebo, stratified by duration of dcSSc. Escape therapy was allowed at 6 months for worsening disease. The coprimary end points were change in the modified Rodnan skin thickness score (MRSS) compared to baseline and safety over 12 months. Differences in longitudinal outcomes were assessed according to treatment using linear mixed models, with outcomes censored after initiation of escape therapy. Skin tissue obtained from participants at baseline was classified into intrinsic gene expression subsets.
resultsAmong 88 participants, the adjusted mean change in the MRSS at 12 months was -6.24 units for those receiving abatacept and -4.49 units for those receiving placebo, with an adjusted mean treatment difference of -1.75 units (P = 0.28). Outcomes for 2 secondary measures (Health Assessment Questionnaire disability index and a composite measure) were clinically and statistically significantly better with abatacept. The proportion of subjects in whom escape therapy was needed was higher in the placebo group relative to the abatacept group (36% versus 16%). In the inflammatory and normal-like skin gene expression subsets, decline in the MRSS over 12 months was clinically and significantly greater in the abatacept group versus the placebo group (P < 0.001 and P = 0.03, respectively). In the abatacept group, adverse events occurred in 35 participants versus 40 participants in the placebo group, including 2 deaths and 1 death, respectively.
conclusionIn this phase II trial, abatacept was well-tolerated, but change in the MRSS was not statistically significant. Secondary outcome measures, including gene expression subsets, showed evidence in support of abatacept. These data should be confirmed in a phase III trial.
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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.