Evidence map›Paper›PMID 37463054›Full record

Trial reportNephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association2023

Effect of belimumab on kidney-related outcomes in patients with lupus nephritis: post hoc subgroup analyses of the phase 3 BLISS-LN trial.

Hans-Joachim Anders, Richard Furie, Ana Malvar, Ming-Hui Zhao, Keiju Hiromura, Julia Weinmann-Menke, Yulia Green, Angela Jones-Leone, Daniela Negrini, Roger A Levy and 3 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01639339 (A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Belimumab Plus Standard of Care Versus Placebo Plus Standard of Care in Adult Subjects With Active Lupus Nephritis), which is not on this map. Cited by 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 pooled it
4.7field-weighted citation impact, top 4% of its field
1 · What the graph read from 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.

2 · The registry

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.

NCT01639339 phase3completednot on this map

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Belimumab Plus Standard of Care Versus Placebo Plus Standard of Care in Adult Subjects With Active Lupus Nephritis

TypeinterventionalSponsorHuman Genome Sciences Inc., a GSK CompanyRan2012 to 2020Enrolled448ConditionsLupus NephritisArmsPlacebo plus standard therapy, Belimumab 10 mg/kg plus standard therapy, Standard therapy
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 1 synthesis or guideline pooled it, 19 citations in OpenAlex.

  1. Guideline
  2. Review
  3. Review
  4. Review
  5. Review
  6. Article
  7. Review
  8. Observational
  9. Lessons Learnt from the Belimumab Trials in Systemic Lupus Erythematosus.International journal of molecular sciences · 2025
    Review
  10. Lupus Nephritis: Unmet Needs and Evolving Solutions.Clinical journal of the American Society of Nephrology : CJASN · 2025
    Review
  11. Lupus nephritis.Nature reviews. Disease primers · 2025
    Review
  12. Article
  13. Article
  14. Article
  15. Review
  16. New Insights on Childhood Lupus Nephritis.International journal of nephrology and renovascular disease · 2025
    Review
  17. Article
  18. Review
  19. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 10 institutions in 5 countries.

Hans-Joachim AndersDepartment of Medicine IV, Hospital of Ludwig Maximilians University Munich, Munich, Germany.ORCID 0000-0003-2434-2956
Richard FurieDivision of Rheumatology, Northwell Health, Great Neck, NY, USA.
Ana MalvarNephrology Research Unit, Organización Médica de Investigación, Buenos Aires, Argentina.
Ming-Hui ZhaoRenal Division, Peking University First Hospital, Beijing, China.
Keiju HiromuraDepartment of Nephrology and Rheumatology, Gunma University Graduate School of Medicine, Maebashi, Japan.
Julia Weinmann-MenkeDepartment of Medicine I, Division of Nephrology, University Medical Center Mainz, Mainz, Germany.ORCID 0000-0001-7344-8381
Yulia GreenClinical Development, GSK, Brentford, Middlesex, UK.
Angela Jones-LeoneSpecialty Care, Global Medical Affairs, GSK, Collegeville, PA, USA.
Daniela NegriniImmunology Biostatistics, GSK, Stevenage, UK.
Roger A LevySpecialty Care, Global Medical Affairs, GSK, Collegeville, PA, USA.
Liz LightstoneDepartment of Immunology and Inflammation, Imperial College London, London, UK.
Yoshiya TanakaThe First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.ORCID 0000-0002-0807-7139
Brad H RovinDivision of Nephrology, The Ohio State University Wexner Medical Center, Columbus, OH, USA.ORCID 0000-0001-5639-0210
GlaxoSmithKline (United States) · USAge UK · GBGunma University · JPImperial College London · GBJohannes Gutenberg University Mainz · DELudwig-Maximilians-Universität München · DENorthwell Health · USPeking University · CNThe Ohio State University Wexner Medical Center · USUniversity of Occupational and Environmental Health Japan · JP

Funding

GSK BEL114054
6 · The paper itself

Abstract

backgroundData on belimumab efficacy in patients with lupus nephritis (LN) according to diagnosis duration or induction therapy are limited. Post hoc analyses of the phase 3, randomized, double-blind BLISS-LN study (GSK BEL114054; NCT01639339) were performed to assess belimumab efficacy on kidney-related outcomes in newly diagnosed and relapsed LN subgroups and according to the use of glucocorticoid (GC) pulses at induction.

methodsBLISS-LN randomized 448 patients with active LN to monthly intravenous belimumab 10 mg/kg or placebo plus standard therapy. Post hoc analyses assessed primary efficacy renal response (PERR) and complete renal response (CRR) at week 104, time to kidney-related event or death and time to first LN flare from week 24 in newly diagnosed and relapsed patients and patients with/without GC pulses at induction.

resultsA greater proportion of patients achieved a PERR with belimumab versus placebo in the newly diagnosed {69/148 [46.6%] versus 55/148 [37.2%]; odds ratio [OR] 1.36 [95% confidence interval (CI) 0.85-2.20]} and relapsed [27/75 (36.0%) versus 17/75 (22.7%); OR 2.31 (95% CI 1.07-5.01)] subgroups. Similarly for CRR [newly diagnosed: 50/148 (33.8%) versus 36/148 (24.3%); OR 1.49 (95% CI 0.88-2.51) and relapsed: 17/75 (22.7%) versus 8/75 (10.7%); OR 3.11 (95% CI 1.16-8.31)]. The probability of kidney-related event or death, or LN flare was lower with belimumab versus placebo in both subgroups. Belimumab was associated with improved kidney outcomes versus placebo with or without GC pulses at induction.

conclusionData suggest consistent benefits of belimumab on kidney outcomes for newly diagnosed and relapsed patients, and irrespective of GC pulses at induction.

Indexed as

Lupus Erythematosus, SystemicLupus NephritisAntibodies, Monoclonal, HumanizedGlucocorticoidsHumansImmunosuppressive AgentsKidneyTreatment OutcomeAntibodies, Monoclonal, HumanizedbelimumabGlucocorticoidsImmunosuppressive AgentsB cellsbelimumabglucocorticoidslupus nephritisproteinuria

Identifiers

PMID37463054
PMCPMC10689192
OpenAlexW4384627186

What OpenQuestion holds

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LicenceCC BY-NC
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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.