ArticleArthritis & rheumatology (Hoboken, N.J.)2019
Safety and Efficacy of Belimumab Plus Standard Therapy for Up to Thirteen Years in Patients With Systemic Lupus Erythematosus.
Article in Arthritis & rheumatology (Hoboken, N.J.), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 58 papers, 3 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
58 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- The 2026 British Society for Rheumatology guideline for the management of children, young people and adults with systemic lupus erythematosus.Rheumatology (Oxford, England) · 2026Guideline
- Drug-Induced Progressive Multifocal Leukoencephalopathy (PML): A Systematic Review and Meta-Analysis.Drug safety · 2024Pooled it
- Belimumab for systemic lupus erythematosus.The Cochrane database of systematic reviews · 2021Pooled it
- Trial
- Trial
- Trial
- Early B Cell and Plasma Cell Kinetics Upon Treatment Initiation Portend Flares in Systemic Lupus Erythematosus: AFrontiers in immunology · 2022Trial
- Belimumab prevention against organ damage over 8 years and safety up to 13 years: three pooled open-label, long-term extension SLE studies.Lupus science & medicine · 2026Article
- Subcutaneous Belimumab Demonstrates Consistent Steady-State Pharmacokinetics and is Well Tolerated in Paediatric Patients with SLE in China: An Open-Label Study.Rheumatology and therapy · 2026Article
- Efficacy of belimumab in children with systemic lupus erythematosus.BMC pediatrics · 2026Observational
- Belimumab in Systemic Lupus Erythematosus: From B-Cell Biology to Disease Modification.Journal of clinical medicine · 2026Review
- Effect of Belimumab on the Cutaneous Manifestations of Patients With Lupus Erythematosus.International journal of dermatology · 2026Article
- Cost-Effectiveness of Early vs Delayed Belimumab Treatment for Systemic Lupus Erythematosus.JAMA network open · 2026Article
- Autoantibodies as Precision Tools in Connective Tissue Diseases: From Epiphenomenon to Endophenotype.Antibodies (Basel, Switzerland) · 2026Review
- Belimumab-induced remission in refractory lupus mesenteric vasculitis: a case report with 49-month follow-up.Frontiers in immunology · 2026Article
- Restoring B cell intrinsic tolerance to lupus autoimmunity: a rational strategy for lupus treatment.Frontiers in immunology · 2026Review
- Belimumab efficacy in mucocutaneous manifestations of systemic lupus erythematosus: a large post hoc analysis of five phase III clinical trials.Rheumatology (Oxford, England) · 2025Article
- Chronic Inflammatory Diseases and Cardiovascular Risk: Current Insights and Future Strategies for Optimal Management.International journal of molecular sciences · 2025Review
- Systemic lupus erythematosus: updated insights on the pathogenesis, diagnosis, prevention and therapeutics.Signal transduction and targeted therapy · 2025Review
- Review
Corrections and comments
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Authors and funding
14 authors.
Funding
Abstract
objectiveTo investigate the long-term safety and efficacy of intravenous (IV) belimumab plus standard of care (SOC) therapy for systemic lupus erythematosus (SLE) in patients with active, autoantibody-positive SLE.
methodsThe study was designed as a multicenter, open-label, continuation study of IV belimumab given every 4 weeks in conjunction with SOC therapy in patients with SLE who completed a phase II, double-blind study. Adverse events (AEs) and laboratory data were monitored from the first belimumab dose (in either study) until 24 weeks after the final dose. Efficacy assessments included SLE Responder Index (SRI) and flare index scores (each assessed at 16-week intervals) and glucocorticoid use (assessed at 4-week intervals).
resultsOf the 476 patients in the parent study, 298 (62.6%) entered the continuation study, of whom 96 (32.2%) remained in the study. Patients received belimumab for up to 13 years (median duration of exposure 3,334.0 days [range 260-4,332 days], total belimumab exposure 2,294 patient-years, median number of infusions 115.5 [range 7-155]). The percentage of patients with AEs each year remained stable or decreased. Normal serum IgG levels were maintained in the majority of patients over the study, and the rate of infections remained stable. The percentage of patients who achieved an SRI response increased from 32.8% (year 1) to 75.6% of those remaining on treatment at year 12. The glucocorticoid dose was decreased in patients who had been receiving >7.5 mg/day at baseline.
conclusionThis study is the longest to date to assess belimumab treatment in patients with SLE in clinical trials. Belimumab was well tolerated with no new safety concerns, and efficacy was maintained in patients who continued the study. For patients who initially exhibited a satisfactory response to belimumab, the treatment continues to be well tolerated and provides long-term disease control.
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