Trial reportJCI insight2022
A randomized, phase II study of sequential belimumab and rituximab in primary Sjögren's syndrome.
Trial report in JCI insight, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02631538 (A Randomized, Double Blind), which is not on this map. Cited by 67 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.
A Randomized, Double Blind (Sponsor Open), Comparative, Multicenter Study to Evaluate the Safety and Efficacy of Subcutaneous Belimumab (GSK1550188) and Intravenous Rituximab Co-administration in Subjects With Primary Sjögren's Syndrome
Who cites it
67 citing papers in PubMed, 6 syntheses or guidelines pooled it, 112 citations in OpenAlex.
- Insights into the pathogenesis of rheumatic and immune diseases from single-cell omics.Frontiers in immunology · 2026Pooled it
- B-cell centrality dictates therapeutic efficacy across autoimmune diseases: a systematic review.Frontiers in immunology · 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
- Meta-analysis of the efficacy and safety of rituximab in the treatment of primary Sjögren's syndrome.Frontiers in immunology · 2025Pooled it
- Comparative efficacy and safety of induction therapy in solid organ transplantation: a systematic review and network meta-analysis.Frontiers in immunology · 2025Pooled it
- Disruption of memory B-cell trafficking by belimumab in patients with systemic lupus erythematosus.Rheumatology (Oxford, England) · 2024Pooled it
- IgA2Cell reports. Medicine · 2025Trial
- The Immune Checkpoint Inhibitors Journey: From Early Promise to Lasting Impact.Journal of immunotherapy and precision oncology · 2026Review
- [Current treatment, foreseeable newcomer and new treatment approaches for Sjögren's disease].Zeitschrift fur Rheumatologie · 2026Review
- Fatigue in Sjögren's Disease - Integrating Biomedical and Psychosocial Aspects: A Narrative Review.Rheumatology and therapy · 2026Review
- Article
- Review
- From Molecular Pathophysiology to Clinical Trial Design in Sjögren's Disease: A Three-Axis Framework.International journal of molecular sciences · 2026Review
- Synergistic Interaction Between MALAT1/miR-30b-5p/BAFF Axis and Inflammatory Cytokines Underlies Rituximab-Refractory NMOSD.CNS neuroscience & therapeutics · 2026Article
- Molecular Insights into Oral Manifestations in Sjögren's Disease.International journal of molecular sciences · 2026Review
- Revisiting the CD40-CD40L axis: from mechanistic insight to therapeutic renewal in autoimmune disease.Current opinion in rheumatology · 2026Review
- A Focused Comparative Review of Innovative Therapeutics Across Autoimmune and Chronic Inflammatory Diseases.Life (Basel, Switzerland) · 2026Review
- mTOR signaling pathway in primary Sjögren's syndrome: Pathogenesis and potential therapeutic targets (Review).International journal of molecular medicine · 2026Review
- Activity and Damage Indices for Sjögren's Disease.Journal of clinical medicine · 2026Review
- Comparative Analysis of Clinical Trials of Biologic Drugs for Patients with Primary Sjögren's Syndrome.Journal of clinical medicine · 2026Review
7 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
19 authors at 10 institutions in 6 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUNDPrimary Sjögren's syndrome (pSS) is characterized by B cell hyperactivity and elevated B-lymphocyte stimulator (BLyS). Anti-BLyS treatment (e.g., belimumab) increases peripheral memory B cells; decreases naive, activated, and plasma B cell subsets; and increases stringency on B cell selection during reconstitution. Anti-CD20 therapeutics (e.g., rituximab) bind and deplete CD20-expressing B cells in circulation but are less effective in depleting tissue-resident CD20+ B cells. Combined, these 2 mechanisms may achieve synergistic effects.METHODSThis 68-week, phase II, double-blind study (GSK study 201842) randomized 86 adult patients with active pSS to 1 of 4 arms: placebo, s.c. belimumab, i.v. rituximab, or sequential belimumab + rituximab.RESULTSOverall, 60 patients completed treatment and follow-up until week 68. The incidence of adverse events (AEs) and drug-related AEs was similar across groups. Infections/infestations were the most common AEs, and no serious infections of special interest occurred. Near-complete depletion of minor salivary gland CD20+ B cells and a greater and more sustained depletion of peripheral CD19+ B cells were observed with belimumab + rituximab versus monotherapies. With belimumab + rituximab, reconstitution of peripheral B cells occurred, but it was delayed compared with rituximab. At week 68, mean (± standard error) total EULAR Sjögren's syndrome disease activity index scores decreased from 11.0 (1.17) at baseline to 5.0 (1.27) for belimumab + rituximab and 10.4 (1.36) to 8.6 (1.57) for placebo.CONCLUSIONThe safety profile of belimumab + rituximab in pSS was consistent with the monotherapies. Belimumab + rituximab induced enhanced salivary gland B cell depletion relative to the monotherapies, potentially leading to improved clinical outcomes.TRIAL REGISTRATIONClinicalTrials.gov NCT02631538.FUNDINGFunding was provided by GSK.
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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.