Trial reportLupus science & medicine2022
Reductions in circulating B cell subsets and immunoglobulin G levels with long-term belimumab treatment in patients with SLE.
Trial report in Lupus science & medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 14 papers.
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 Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 76-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE)
A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed the Phase 3 Protocol HGS1006-C1056 in the United States
Who cites it
14 citing papers in PubMed, 17 citations in OpenAlex.
- Regulatory B cell expansion and type 1 innate lymphoid cell suppression characterise immune modulation in paediatric lupus nephritis.RMD open · 2026Trial
- Belimumab in Systemic Lupus Erythematosus: From B-Cell Biology to Disease Modification.Journal of clinical medicine · 2026Review
- Treatment strategies for rituximab-resistant primary membranous nephropathy: from resistance mechanisms to emerging therapies.Frontiers in immunology · 2026Review
- Prospective analysis of B cell subset dynamics following telitacicept treatment in systemic lupus erythematosus.Arthritis research & therapy · 2025Article
- Article
- Mechanistic Evaluation of Anti-CD19 CAR-T Cell Therapy Repurposed in Systemic Lupus Erythematosus Using a Quantitative Systems Pharmacology Model.Clinical and translational science · 2025Article
- Belimumab combined with mycophenolate mofetil for treating severe lupus nephritis: effects on renal recovery, immune regulation, and long-term prognosis.American journal of translational research · 2025Article
- Secondary antibody deficiencies: what's around the corner?Frontiers in immunology · 2025Review
- Serum IFN-γ Predicts the Therapeutic Effect of Belimumab in Refractory Lupus Nephritis Patients.Pharmacogenomics and personalized medicine · 2024Article
- B Cell Lymphocytosis in Juvenile Dermatomyositis.Diagnostics (Basel, Switzerland) · 2023Article
- Efficacy and Safety of New B Cell-Targeted Biologic Agent for the Treatment of Systemic Lupus Erythematosus: A Systematic Review and Meta-Analysis.Journal of clinical medicine · 2023Review
- Population model-based analysis of the memory B-cell response following belimumab therapy in the treatment of systemic lupus erythematosus.CPT: pharmacometrics & systems pharmacology · 2023Article
- The rapid inhibition of B-cell activation markers by belimumab was associated with disease control in systemic lupus erythematosus patients.Frontiers in pharmacology · 2023Article
- New Treatment Strategies for IgA Nephropathy: Targeting Plasma Cells as the Main Source of Pathogenic Antibodies.Journal of clinical medicine · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 3 institutions in 1 country.
Funding
Abstract
objectiveTo examine the long-term changes in circulating B cell subsets and IgG levels at 5+ years of continuous belimumab treatment and their correlations with efficacy and safety measures.
methodsThis was a post hoc analysis of a continuation study (BEL112233; NCT00724867) of eligible US patients who completed the 76-week BLISS-76 Study (BEL110751; NCT00410384), with up to eight calendar-years of follow-up and median (IQR) belimumab exposure of 310 (209, 364) weeks. From week 76, patients initially randomised to intravenous belimumab 1 mg/kg or 10 mg/kg every 4 weeks in BLISS-76 continued to receive the same dose in the continuation study, while those initially randomised to placebo received belimumab 10 mg/kg intravenous every 4 weeks during continuation. All patients continued to receive standard SLE therapy. Biomarker data were collected, and the effects on baseline and early changes (weeks 0-24 after starting belimumab) from baseline in biomarkers on SLE Responder Index (SRI-4) and infection rate were evaluated.
resultsOf the 819 patients from BLISS-76, 268 self-selecting patients entered BEL112233. Compared with baseline, B cell subset counts decreased by 40%-99% after 312 weeks (6 years), and serum IgG levels decreased by 28% after 284 weeks. Higher baseline naïve B cell counts were associated with greater SRI-4 response rates (p<0.05), whereas higher baseline SLE subset plasma and short-lived plasma B cell counts were associated with lower SRI-4 response rates (p<0.05). Elevated baseline IgG levels were associated with increased infection rates over the treatment period (p<0.05), and early greater decreases in IgG levels were associated with higher SRI-4 response rates (p<0.05).
conclusionsBelimumab treatment up to 312 weeks (6 years) resulted in substantial decreases in several circulating B cell subsets and IgG levels. Higher baseline naïve B cell counts and IgG levels were associated with improved SRI-4 response and increased infection rates, respectively.
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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.