ArticleTrials2022
Efficacy of belimumab combined with rituximab in severe systemic lupus erythematosus: study protocol for the phase 3, multicenter, randomized, open-label Synbiose 2 trial.
Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03747159 (A Randomized Trial to Investigate the Reset of Humoral Autoimmunity by Combining Belimumab with Rituximab in Severe Systemic Lupus Erythematosus), which is not on this map. Cited by 18 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.
A Randomized Trial to Investigate the Reset of Humoral Autoimmunity by Combining Belimumab with Rituximab in Severe Systemic Lupus Erythematosus
Who cites it
18 citing papers in PubMed, 2 syntheses or guidelines pooled it, 27 citations in OpenAlex.
- Disruption of memory B-cell trafficking by belimumab in patients with systemic lupus erythematosus.Rheumatology (Oxford, England) · 2024Pooled it
- Safety and efficacy of biologics in childhood systemic lupus erythematosus: a critical systematic review.Clinical rheumatology · 2024Pooled it
- Long-term safety and efficacy of the combination of belimumab and rituximab in the treatment of severe and refractory SLE: a preliminary report.Lupus science & medicine · 2025Trial
- Disease modification in lupus nephritis: towards a pathophysiology-based treatment paradigm.Nature reviews. Nephrology · 2026Review
- From immune dysregulation to renal injury: mechanistic insights and translational opportunities in immune-mediated nephropathies.Frontiers in cell and developmental biology · 2026Review
- Taming renal inflammation: signaling pathways and therapeutic advances in lupus nephritis.BMC nephrology · 2025Review
- Review
- Article
- The influence of the gut microbiota on B cells in autoimmune diseases.Molecular medicine (Cambridge, Mass.) · 2025Review
- Virtual patients inspired by multiomics predict the efficacy of an anti-IFNα mAb in cutaneous lupus.iScience · 2025Article
- Opportunities and limitations of B cell depletion approaches in SLE.Nature reviews. Rheumatology · 2025Review
- Case Report: Remission of a patient with complex combination of autoimmune diseases by anti-CD19 CAR-T cell therapy.Frontiers in immunology · 2025Article
- [Safe pregnancy and delivery in a female patient with systemic lupus erythematosus after discontinuation of dual-target chimeric antigen receptor T cells therapy].Beijing da xue xue bao. Yi xue ban = Journal of Peking University. Health sciences · 2024Article
- Systemic lupus erythematosus: pathogenesis and targeted therapy.Molecular biomedicine · 2024Review
- Lupus Nephritis from Pathogenesis to New Therapies: An Update.International journal of molecular sciences · 2024Review
- A new perspective on therapies involving B-cell depletion in autoimmune diseases.Molecular biology reports · 2024Article
- Immunotherapeutic approaches for systemic lupus erythematosus: early overview and future potential.Medical review (2021) · 2023Review
- Promising Experimental Treatments for Lupus Nephritis: Key Talking Points and Potential Opportunities.Research and reports in urology · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 6 institutions in 3 countries.
Funding
Abstract
backgroundBelimumab, an anti-B-cell activating factor antibody, is approved for the treatment of auto-antibody positive systemic lupus erythematosus with a high degree of disease activity. Anti-CD20 B cell depletion with rituximab is used in refractory SLE as well, although with variable responses. We hypothesized that incomplete B cell depletion, related to a surge in BAFF levels following rituximab treatment, can cause ongoing disease activity and flares. The Synbiose 1 study primarily focused on immunological effects and shows the preliminary clinical benefit of combined rituximab and belimumab in SLE. The Synbiose 2 study will evaluate the clinical efficacy of combining belimumab with rituximab in patients with severe SLE, allowing the tapering of prednisolone and mycophenolate.
methodsSynbiose 2 is a phase 3, multicenter, randomized, controlled, open-label 2-year clinical trial. Seventy adults with severe SLE including lupus nephritis will be randomized 1:1 to receive either standard of care consisting of prednisolone and mycophenolate as induction and maintenance treatment, or belimumab and rituximab combined with standard of care as induction treatment, followed by prednisolone and belimumab as maintenance treatment. The primary objective is to assess whether combined B cell therapy will lead to a reduction of treatment failure. Secondary endpoints are complete and partial clinical and renal response and the improvement of SLE-specific autoimmune phenomena. Safety endpoints include the incidence of adverse events, with a special interest in infections. DISCUSSION: The Synbiose 2 trial is the first multicenter phase 3 clinical trial investigating combined B cell targeted therapy in SLE, including lupus nephritis. The outcome of this study will provide further evidence for the clinical efficacy of this new treatment strategy in severe SLE.
trial registrationClinicalTrials.gov NCT03747159 . Registered on 20 November 2018.
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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.