Trial reportArthritis research & therapy2010
B cell depletion in diffuse progressive systemic sclerosis: safety, skin score modification and IL-6 modulation in an up to thirty-six months follow-up open-label trial.
Trial report in Arthritis research & therapy, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01748084 (Evaluation of Rituximab in Systemic Sclerosis Associated Polyarthritis), which is not on this map. Cited by 72 papers, 2 of them syntheses that pooled it.
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.
Evaluation of Rituximab in Systemic Sclerosis Associated Polyarthritis
Who cites it
72 citing papers in PubMed, 2 syntheses or guidelines pooled it, 193 citations in OpenAlex.
- Efficacy and safety of rituximab therapy in patients with systemic sclerosis disease (SSc): systematic review and meta-analysis.Clinical rheumatology · 2021Pooled it
- Efficacy and safety of rituximab on lung and skin involvement in systemic sclerosis: a systematic review and metaanalysis.Clinical rheumatology · 2021Pooled it
- Trial
- Safety and tolerability of an anti-CD19 monoclonal antibody, MEDI-551, in subjects with systemic sclerosis: a phase I, randomized, placebo-controlled, escalating single-dose study.Arthritis research & therapy · 2016Trial
- B cell depletion therapy upregulates Dkk-1 skin expression in patients with systemic sclerosis: association with enhanced resolution of skin fibrosis.Arthritis research & therapy · 2016Trial
- B-cell depletion therapy in patients with diffuse systemic sclerosis associates with a significant decrease in PDGFR expression and activation in spindle-like cells in the skin.Arthritis research & therapy · 2012Trial
- Deep phenotyping of skin tissue remodeling in patients with systemic sclerosis treated with CD19-CAR T cells.Nature communications · 2026Article
- Roads and detours for CAR T cell therapy in autoimmune diseases.Nature reviews. Drug discovery · 2026Review
- Case study of resecabtagene autoleucel in a subject with diffuse cutaneous systemic sclerosis treated in the RESET-SSc trial.Molecular therapy. Advances · 2026Article
- Integrating B Cell Differentiation Model With Real-World Data Informs Determinants for Antibody-Secreting Cell Depletions in Systemic Sclerosis.CPT: pharmacometrics & systems pharmacology · 2026Article
- Case-Based Immunology: B Cells and Systemic Sclerosis Interstitial Lung Disease.Arthritis & rheumatology (Hoboken, N.J.) · 2026Review
- Efficacy and safety of autologous hematopoietic stem cell transplantation for refractory systemic sclerosis after rituximab-bendamustine conditioning.American journal of translational research · 2026Article
- [S2k guidelines on diagnostics and treatment of systemic sclerosis : Full version].Zeitschrift fur Rheumatologie · 2025Review
- [Experiences after CD19-CAR T-cell therapy in non-SLE connective tissue diseases].Zeitschrift fur Rheumatologie · 2025Review
- The B-cells paradigm in systemic sclerosis: an update on pathophysiology and B-cell-targeted therapies.Clinical and experimental immunology · 2025Review
- Breaking the cycle: should we target inflammation, fibrosis, or both?Frontiers in immunology · 2025Review
- Long-term outcome of autologous haematopoietic stem cell transplantation in patients with systemic sclerosis: a comparison with patients treated with rituximab and with traditional immunosuppressive agents.Arthritis research & therapy · 2024Article
- Revolutionizing Treatment Strategies for Autoimmune and Inflammatory Disorders: The Impact of Dipeptidyl-Peptidase 4 Inhibitors.Journal of inflammation research · 2024Review
- Treatable Traits in Systemic Sclerosis.Clinical reviews in allergy & immunology · 2023Review
- Anti-topoisomerase 1 Antibody Level Changes after B Cell Depletion Therapy in Systemic Sclerosis.Doklady. Biochemistry and biophysics · 2023Article
12 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
8 authors at 1 institution in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionAn over-expression of CD19 has been shown in B cells of systemic sclerosis (SSc) and B cells are thought to contribute to the induction of skin fibrosis in the tight skin mouse model. The aim was to define the outcome on safety and the change in skin score after rituximab therapy in SSc patients and to correlate the clinical characteristics with the levels of interleukin (IL)-6 and with the immune cell infiltrate detected by immunohistochemistry.
methodsNine patients with SSc with mean age 40.9 +/- 11.1 years were treated with anti-CD20, 1 g at time 0 and after 14 days. Skin biopsy was performed at baseline and during the follow-up. B-cell activating factor (BAFF) and IL-6 levels were also determined at the follow-up times.
resultsAfter 6 months patients presented a median decrease of the skin score of 43.3% (range 21.1-64.0%), and a decrease in disease activity index and disease severity index. IL-6 levels decreased permanently during the follow up. After treatment, a complete depletion of peripheral blood B cells was observed in all but 2 patients. Only 3 patients presented CD20 positive cells in the biopsy of the involved skin at baseline.
conclusionsAnti-CD20 treatment has been well tolerated and SSc patients experienced an improvement of the skin score and of clinical symptoms. The clear fall in IL-6 levels could contribute to the skin fibrosis improvement, while the presence of B cells in the skin seems to be irrelevant with respect to the outcome after B cell depletion.
trial registrationISRCTN77554566.
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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.