Trial reportArthritis and rheumatism2012
Belimumab reduces autoantibodies, normalizes low complement levels, and reduces select B cell populations in patients with systemic lupus erythematosus.
Trial report in Arthritis and rheumatism, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 206 papers, 8 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
206 citing papers in PubMed, 8 syntheses or guidelines pooled it, 411 citations in OpenAlex.
- Indirect comparative efficacy and safety of belimumab vs. anifrolumab in systemic lupus erythematosus and lupus nephritis: a meta-analysis of randomized trials.Zeitschrift fur Rheumatologie · 2026Pooled it
- Biomarker-stratified efficacy and safety of biologics in systemic lupus erythematosus: a systematic review and meta-analysis.Lupus science & medicine · 2026Pooled it
- Comparative efficacy and acceptability of novel biologics in the treatment of myasthenia gravis: systematic review and network meta-analysis of randomized trials.Systematic reviews · 2025Pooled it
- Organ-based characterization of B cells in patients with systemic lupus erythematosus.Frontiers in immunology · 2025Pooled it
- Disruption of memory B-cell trafficking by belimumab in patients with systemic lupus erythematosus.Rheumatology (Oxford, England) · 2024Pooled it
- Belimumab for systemic lupus erythematosus.The Cochrane database of systematic reviews · 2021Pooled it
- Biologics in the Treatment of Lupus Erythematosus: A Critical Literature Review.BioMed research international · 2019Pooled it
- Lymphocytes as Biomarkers of Therapeutic Response in Rheumatic Autoimmune Diseases, Is It a Realistic Goal?Clinical reviews in allergy & immunology · 2017Pooled it
- Unsupervised machine learning identifies distinct SLE patient endotypes with differential response to belimumab.Rheumatology (Oxford, England) · 2025Trial
- Trial
- A first-in-human, randomized study of the safety, pharmacokinetics and pharmacodynamics of povetacicept, an enhanced dual BAFF/APRIL antagonist, in healthy adults.Clinical and translational science · 2024Trial
- Belimumab treatment of adult idiopathic inflammatory myopathy.Rheumatology (Oxford, England) · 2024Trial
- Belimumab and antimalarials combined against renal flares in patients treated for extra-renal systemic lupus erythematosus: results from 4 phase III clinical trials.Rheumatology (Oxford, England) · 2024Trial
- A randomized, phase II study of sequential belimumab and rituximab in primary Sjögren's syndrome.JCI insight · 2022Trial
- B Cell Kinetics upon Therapy Commencement for Active Extrarenal Systemic Lupus Erythematosus in Relation to Development of Renal Flares: Results from Three Phase III Clinical Trials of Belimumab.International journal of molecular sciences · 2022Trial
- Pharmacokinetic Characteristics, Safety, and Tolerability of Telitacicept, an Injectable Recombinant Human B-Lymphocyte Stimulating Factor Receptor-Antibody Fusion Protein, in Healthy Chinese Subjects.Clinical pharmacology in drug development · 2022Trial
- Reductions in circulating B cell subsets and immunoglobulin G levels with long-term belimumab treatment in patients with SLE.Lupus science & medicine · 2022Trial
- Early B Cell and Plasma Cell Kinetics Upon Treatment Initiation Portend Flares in Systemic Lupus Erythematosus: AFrontiers in immunology · 2022Trial
- Phase II Randomized Trial of Rituximab Plus Cyclophosphamide Followed by Belimumab for the Treatment of Lupus Nephritis.Arthritis & rheumatology (Hoboken, N.J.) · 2021Trial
- Safety and efficacy of intravenous belimumab in children with systemic lupus erythematosus: results from a randomised, placebo-controlled trial.Annals of the rheumatic diseases · 2020Trial
146 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
17 authors at 10 institutions in 5 countries.
Funding
Abstract
objectiveTo assess the effects of the B lymphocyte stimulator (BLyS)-specific inhibitor belimumab on immunologic biomarkers, including B cell and T cell populations, and maintenance of antibody titers to prior vaccines in autoantibody-positive systemic lupus erythematosus (SLE) patients.
methodsPooled data from 2 phase III trials, the Study of Belimumab in Subjects with SLE 52-week (BLISS-52) and 76-week (BLISS-76) trials, comparing belimumab 1 mg/kg or 10 mg/kg versus placebo (plus standard SLE therapy for each group) were analyzed for changes in autoantibody, immunoglobulin, and complement levels. BLISS-76 patients were also analyzed for changes in B cell and T cell populations and effects on prior vaccine-induced antibody levels.
resultsBelimumab-treated patients experienced significant sustained reductions in IgG and autoantibodies and improvement in C3/C4 levels, resulting in greater positive-to-negative conversion rates for IgG anti-double-stranded DNA (anti-dsDNA), anti-Sm, anticardiolipin, and anti-ribosomal P autoantibodies and normalization of hypergammaglobulinemia and low C3/C4 levels. Belimumab-treated patients experienced significant decreases in the numbers of naive and activated B cells, as well as plasma cells, whereas memory B cells and T cell populations did not decrease. Belimumab did not substantially affect preexisting antipneumococcal or anti-tetanus toxoid antibody levels. Post hoc analysis showed greater reductions in SLE disease activity and the risk of severe flares in patients treated with belimumab 10 mg/kg (P≤0.01) who were anti-dsDNA positive and had low C3/C4 levels at baseline. Normalization of the C3 or anti-dsDNA level by 8 weeks, irrespective of therapy, was predictive of a reduced risk of severe flare over 52 weeks.
conclusionBelimumab appears to promote normalization of serologic activity and reduce BLyS-dependent B cell subsets in serologically and clinically active SLE. Greater serologic activity may predict a better treatment response to belimumab.
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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.