Evidence map›Paper›PMID 37228028›Full record

Trial reportRheumatology (Oxford, England)2024

Belimumab and antimalarials combined against renal flares in patients treated for extra-renal systemic lupus erythematosus: results from 4 phase III clinical trials.

Alvaro Gomez, Sandra Jägerback, Christopher Sjöwall, Ioannis Parodis

4 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase III
In one paragraph

Trial report in Rheumatology (Oxford, England), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 23 papers.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed
9.7field-weighted citation impact, top 1% 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.

NCT00410384 phase3completednot on this map

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)

TypeinterventionalSponsorHuman Genome Sciences Inc.Ran2006 to 2010Enrolled819ConditionsSystemic Lupus ErythematosusArmsPlacebo, Belimumab 1 mg/kg, Belimumab 10 mg/kg
NCT00424476 phase3completednot on this map

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Wk 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)

TypeinterventionalSponsorHuman Genome Sciences Inc.Ran2007 to 2010Enrolled865ConditionsSystemic Lupus ErythematosusArmsPlacebo, Belimumab 1 mg/kg, Belimumab 10 mg/kg
NCT01345253 phase3completednot on this map

GSK1550188 A 52 Week Study of Belimumab Versus Placebo in the Treatment of Subjects With Systemic Lupus Erythematosus (SLE) Located in Northeast Asia

TypeinterventionalSponsorGlaxoSmithKlineRan2011 to 2018Enrolled709ConditionsSystemic Lupus ErythematosusArmsBelimumab, Placebo
NCT01484496 phase3completednot on this map

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects With Systemic Lupus Erythematosus (SLE)

TypeinterventionalSponsorHuman Genome Sciences Inc., a GSK CompanyRan2011 to 2015Enrolled839ConditionsSystemic Lupus ErythematosusArmsPlacebo, Belimumab 200 mg SC, Standard therapy
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 39 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Article
  5. Article
  6. Lessons Learnt from the Belimumab Trials in Systemic Lupus Erythematosus.International journal of molecular sciences · 2025
    Review
  7. Lupus nephritis.Nature reviews. Disease primers · 2025
    Review
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Review
  15. Review
  16. Ten tips in lupus nephritis management.Clinical kidney journal · 2025
    Review
  17. Review
  18. Article
  19. Comment on "Belimumab on PreventingKidney international reports · 2024
    Article
  20. 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

4 authors at 3 institutions in 1 country.

Alvaro GomezDivision of Rheumatology, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden.
Sandra JägerbackDivision of Rheumatology, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden.
Christopher SjöwallDepartment of Biomedical and Clinical Sciences, Division of Inflammation and Infection, Linköping University, Linköping, Sweden.ORCID 0000-0003-0900-2048
Ioannis ParodisDivision of Rheumatology, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden.ORCID 0000-0002-4875-5395
Karolinska University Hospital · SEDanderyds sjukhus · SELinköping University · SE

Funding

King Gustaf V's 80-year Foundation FAI-2020-0741Nanna Svartz Foundation 2020-00368Region Östergötland RÖ-932055Swedish Rheumatism Association R-941095Swedish Society of Medicine SLS-974449Ulla and Roland Gustafsson Foundation
6 · The paper itself

Abstract

objectivesTo determine the effect of antimalarial agents (AMA) and different doses and pharmaceutical forms of belimumab on preventing renal flares in patients with SLE treated for extra-renal disease.

methodsWe pooled data from the BLISS-52, BLISS-76, BLISS-SC and BLISS-Northeast Asia trials of belimumab (n = 3225), that included patients with active SLE yet no severe ongoing nephritis. Participants were allocated to receive intravenous belimumab 1 mg/kg, intravenous belimumab 10 mg/kg, subcutaneous belimumab 200 mg, or placebo in addition to standard therapy. We estimated hazards of renal flare development throughout the study follow-up (52-76 weeks) using Cox regression analysis.

resultsIn total, 192 patients developed a renal flare after a median of 197 days. Compared with placebo, the risk of renal flares was lower among patients receiving intravenous belimumab 10 mg/kg (HR: 0.62; 95% CI: 0.41, 0.92; P = 0.018) and intravenous belimumab 1 mg/kg (HR: 0.42; 95% CI: 0.22, 0.79; P = 0.007), while no significant association was found for subcutaneous belimumab 200 mg. AMA use yielded a lower hazard of renal flares (HR: 0.66; 95% CI: 0.55, 0.78; P < 0.001). The protection conferred was enhanced when belimumab and AMA were co-administered; the lowest flare rate was observed for the combination intravenous belimumab 1 mg/kg and AMA (18.5 cases per 1000 person-years).

conclusionsThe protection conferred from belimumab against renal flare development in patients treated for extra-renal SLE appears enhanced when belimumab was administered along with AMA. The prominent effect of low-dose belimumab warrants investigation of the efficacy of intermediate belimumab doses. CLINICAL TRIAL IDENTIFICATION: BLISS-52: NCT00424476; BLISS-76: NCT00410384; BLISS-SC: NCT01484496; BLISS-NEA: NCT01345253.

Indexed as

Antibodies, Monoclonal, HumanizedAntimalarialsLupus Erythematosus, SystemicHumansImmunosuppressive AgentsTreatment OutcomeAntibodies, Monoclonal, HumanizedAntimalarialsbelimumabImmunosuppressive AgentsbelimumabB lymphocyteflaresglomerulonephritisLNrenal diseaseSLEtertiary preventiontreatment outcomes

Identifiers

PMID37228028
PMCPMC10836979
OpenAlexW4378193376

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.