Trial reportArthritis & rheumatology (Hoboken, N.J.)2018
Belimumab for the Treatment of Early Diffuse Systemic Sclerosis: Results of a Randomized, Double-Blind, Placebo-Controlled, Pilot Trial.
Trial report in Arthritis & rheumatology (Hoboken, N.J.), 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 77 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.
Safety and Efficacy of Itacitinib in Adults With Systemic Sclerosis: a Phase II, Randomized, Controlled Trial
The Effectiveness of ECP in Diffuse Cutaneous Systemic Sclerosis
An Open Label Extension Study of Brentuximab Vedotin Treatment in Active Diffuse Cutaneous Systemic Sclerosis (Diffuse Scleroderma)
Who cites it
77 citing papers in PubMed, 6 syntheses or guidelines pooled it, 127 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
- Beyond systemic lupus erythematosus: a systematic review on the use of belimumab in other connective tissue diseases and vasculitides.Clinical rheumatology · 2026Pooled it
- Disruption of memory B-cell trafficking by belimumab in patients with systemic lupus erythematosus.Rheumatology (Oxford, England) · 2024Pooled it
- 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
- An update on targeted therapies in systemic sclerosis based on a systematic review from the last 3 years.Arthritis research & therapy · 2021Pooled it
- Tofacitinib in the treatment of skin and musculoskeletal involvement in patients with systemic sclerosis, evaluated by ultrasound.Rheumatology international · 2021Trial
- Disease activity and anti-topoisomerase I antibody positivity are associated with elevated serum B cell activating factor levels and a B cell subset-wide reduction of BAFF-receptor expression in SSc.Rheumatology (Oxford, England) · 2026Article
- Case-Based Immunology: B Cells and Systemic Sclerosis Interstitial Lung Disease.Arthritis & rheumatology (Hoboken, N.J.) · 2026Review
- Anti-CD19 CAR T cells for pediatric patients with treatment-refractory autoimmune diseases.Nature medicine · 2026Article
- Systematic Review and Model-Based Meta-Analysis of Targeted Drugs for Systemic Sclerosis.Pharmaceutics · 2026Review
- 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
- Serum CXCL-13 levels in patients with progressive systemic sclerosis are associated with the severity of interstitial lung disease.Rheumatology advances in practice · 2026Article
- Systemic sclerosis: pathogenic mechanisms and their implications for treatment.Seminars in immunopathology · 2025Review
- A comprehensive study on drug-related Raynaud's phenomenon based on the FDA adverse event reporting system.Scientific reports · 2025Article
- Immunosuppressive Drugs in Early Systemic Sclerosis and Prevention of Damage Accrual.Arthritis care & research · 2025Observational
- Review
- A new era in the treatment of progressive fibrosing interstitial lung diseases.Breathe (Sheffield, England) · 2025Review
- The B-cells paradigm in systemic sclerosis: an update on pathophysiology and B-cell-targeted therapies.Clinical and experimental immunology · 2025Review
17 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
10 authors at 4 institutions in 1 country.
Funding
Abstract
objectiveTo assess the safety and efficacy of treatment with belimumab in patients with early diffuse cutaneous systemic sclerosis (dcSSc) treated with background mycophenolate mofetil (MMF).
methodsIn this 52-week, investigator-initiated, single-center, double-blind, placebo-controlled, pilot study, 20 patients with dcSSc recently started on MMF were randomized 1:1 to additionally receive belimumab at 10 mg/kg intravenously or placebo. We assessed safety, efficacy, and differential gene expression.
resultsIn the belimumab group, the median modified Rodnan skin thickness score (MRSS) decreased from 27 (interquartile range [IQR] 26.5, 31) to 18 (IQR 11, 23) (P = 0.039). In the placebo group, the median MRSS decreased from 28 (IQR 22, 28) to 21 (IQR 14, 25) (P = 0.023). The median change in MRSS was -10 (IQR -13, -9) in the belimumab group and -3.0 (IQR -15, -1) in the placebo group (P = 0.411). There were no significant differences between the groups in the number of adverse events (AEs). A significant decrease in expression of B cell signaling and profibrotic genes and pathways was observed in patients with improved MRSS in the belimumab group but not in the placebo group.
conclusionPatients in both treatment groups experienced significant improvements in MRSS. The median difference was greater in the belimumab group but did not achieve statistical significance in this small pilot study. AEs were similar between the groups. Changes in gene expression were consistent with mechanism of action and showed that clinical response to treatment with belimumab is associated with a significant decrease in profibrotic genes and pathways. Additional studies are needed to determine the role of belimumab in the treatment of dcSSc.
Indexed as
Identifiers
What OpenQuestion holds
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.