Trial reportAnnals of the rheumatic diseases2020
Safety and efficacy of intravenous belimumab in children with systemic lupus erythematosus: results from a randomised, placebo-controlled trial.
Trial report in Annals of the rheumatic diseases, 2020. 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 109 papers, 9 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 Multi-center, Randomized, Placebo-Controlled Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients With Systemic Lupus Erythematosus
Low- Versus High-Dose Initial Glucocorticoid Therapy for Childhood-Onset Proliferative Lupus Nephritis: a Multicenter Open-Label Noninferiority Randomized Controlled Trial
Who cites it
109 citing papers in PubMed, 9 syntheses or guidelines pooled it, 182 citations in OpenAlex.
- The 2026 British Society for Rheumatology guideline for the management of children, young people and adults with systemic lupus erythematosus.Rheumatology (Oxford, England) · 2026Guideline
- Organ-based characterization of B cells in patients with systemic lupus erythematosus.Frontiers in immunology · 2025Pooled it
- Efficacy and safety of biologics, multitarget therapy, and standard therapy for lupus nephritis: a systematic review and network meta-analysis.Renal failure · 2024Pooled it
- 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
- Towards development of treat to target (T2T) in childhood-onset systemic lupus erythematosus: PReS-endorsed overarching principles and points-to-consider from an international task force.Annals of the rheumatic diseases · 2023Pooled it
- Interventions for cutaneous disease in systemic lupus erythematosus.The Cochrane database of systematic reviews · 2021Pooled it
- Clinical Courses of IKAROS and CTLA4 Deficiencies: A Systematic Literature Review and Retrospective Longitudinal Study.Frontiers in immunology · 2021Pooled it
- A Comprehensive Review of Biological Agents for Lupus: Beyond Single Target.Frontiers in immunology · 2020Pooled it
- Trial
- Determinants of neuropsychiatric flares in patients with systemic lupus erythematosus: results from five phase III trials of belimumab.Rheumatology (Oxford, England) · 2024Trial
- Effect of belimumab on kidney-related outcomes in patients with lupus nephritis: post hoc subgroup analyses of the phase 3 BLISS-LN trial.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2023Trial
- Extrapolation of Adult Efficacy Data to Pediatric Systemic Lupus Erythematosus: Evaluating Similarities in Exposure-Response.Journal of clinical pharmacology · 2023Trial
- Trial
- Risk of psychiatric disorders and all-cause mortality with belimumab therapy in patients with systemic lupus erythematosus: a meta-analysis of randomised controlled trials.Lupus science & medicine · 2021Trial
- Pharmacokinetics of Belimumab in Children With Systemic Lupus Erythematosus.Clinical pharmacology in drug development · 2021Trial
- Rapid early renal response to add-on belimumab in lupus nephritis.Pediatric nephrology (Berlin, Germany) · 2026Article
- Duration of Belimumab Therapy and Timing of Initiation as Predictors of Clinical Outcomes in Childhood-Onset Systemic Lupus Erythematosus: A Real-World Retrospective Study.Rheumatology and therapy · 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
- Managing Sjögren's Disease in Pediatric Patients.Paediatric drugs · 2026Review
49 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
26 authors at 15 institutions in 8 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesThis ongoing Phase-2, randomised, placebo-controlled, double-blind study evaluated the efficacy, safety and pharmacokinetics of intravenous belimumab in childhood-onset systemic lupus erythematosus (cSLE).
methodsPatients (5 to 17 years) were randomised to belimumab 10 mg/kg intravenous or placebo every 4 weeks, plus standard SLE therapy. Primary endpoint: SLE Responder Index (SRI4) response rate (Week 52). Key major secondary endpoints: proportion of patients achieving the Paediatric Rheumatology International Trials Organisation/American College of Rheumatology (PRINTO/ACR) response using 50 and '30 alternative' definitions (Week 52), and sustained response (Weeks 44 to 52) by SRI4 and Parent Global Assessment of well-being (Parent-global). Safety and pharmacokinetics were assessed. Study not powered for statistical testing.
resultsNinety-three patients were randomised (belimumab, n=53; placebo, n=40). At Week 52, there were numerically more SRI4 responders with belimumab versus placebo (52.8% vs 43.6%; OR 1.49 (95% CI 0.64 to 3.46)). PRINTO/ACR 30 alternative (52.8% vs 27.5%; OR 2.92 (95% CI 1.19 to 7.17)) and PRINTO/ACR 50 (60.4% vs 35.0%; OR 2.74 (95% CI 1.15 to 6.54)) responses were more frequent with belimumab than placebo, as were sustained responses for SRI4 (belimumab, 43.4%; placebo, 41.0%; OR 1.08 (95% CI 0.46 to 2.52)) and Parent-global (belimumab, 59.1%; placebo, 33.3%; OR 3.49 (95% CI 1.23 to 9.91)). Serious adverse events were reported in 17.0% of belimumab patients and 35.0% of placebo patients; one death occurred (placebo). Week-52, geometric mean (95% CI) belimumab trough concentration was 56.2 (45.2 to 69.8) µg/mL.
conclusionThe belimumab intravenous pharmacokinetics and benefit-risk profile in cSLE are consistent with adult belimumab studies and the 10 mg/kg every 4 weeks dose is appropriate. TRIAL REGISTRATION NUMBER: NCT01649765.
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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.