Evidence map›Paper›PMID 40322925›Full record

Trial reportLupus2025

The effect of belimumab on mucocutaneous and vasculitis manifestations in patients with systemic lupus erythematosus: A large pooled post hoc analysis.

Susan Manzi, Jorge Sánchez-Guerrero, Naoto Yokogawa, Joerg Wenzel, Josephine C Ocran-Appiah, Julia Hn Harris, Munther Khamashta, Bernard Rubin, Norma Lynn Fox, Roger A Levy and 1 more

5 registry-linked trialsAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Lupus, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 5 registered trials, which are not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
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
NCT01632241 phase4completednot on this map

A Phase 3/4, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) in Adult Subjects of Black Race With Systemic Lupus Erythematosus (SLE)

TypeinterventionalSponsorHuman Genome Sciences Inc., a GSK CompanyRan2013 to 2019Enrolled503ConditionsSystemic Lupus ErythematosusArmsPlacebo plus standard therapy, Belimumab 10 mg/kg plus standard therapy, Standard therapy
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. Article
  5. [Lupus erythematosus].Dermatologie (Heidelberg, Germany) · 2025
    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

11 authors.

Susan ManziAllegheny Health Network, Lupus Center of Excellence, Pittsburgh, PA, USA.
Jorge Sánchez-GuerreroDivision of Rheumatology, Department of Medicine Mount Sinai Hospital/University Health Network, University of Toronto, Toronto, ON, Canada.
Naoto YokogawaDepartment of Rheumatic Diseases, Tokyo Metropolitan Tama Medical Center, Tokyo, Japan.ORCID 0000-0002-7814-443X
Joerg WenzelDepartment of Dermatology and Allergy, University Hospital of Bonn, Bonn, Germany.
Josephine C Ocran-AppiahClinical Science, GSK, Respiratory and Immunology Clinical Research and Early Programs, Philadelphia, PA, USA.
Julia Hn HarrisImmunology Biostatistics, GSK, London, UK.
Munther KhamashtaMedical Affairs, GSK, Dubai, UAE.ORCID 0000-0002-8927-6024
Bernard RubinUS Medical Affairs and Immuno-inflammation, GSK, Durham, NC, USA.
Norma Lynn FoxClinical Development, GSK, Collegeville, PA, USA.
Roger A LevyGlobal Medical Affairs, GSK, Collegeville, PA, USA.
Victoria P WerthDepartment of Dermatology, Perelman School of Medicine, Philadelphia, PA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

ObjectiveTo investigate the effects of belimumab (BEL) on systemic lupus erythematosus (SLE) mucocutaneous and vasculitis manifestations.MethodsThis post hoc, integrated Belimumab Summary of Lupus Efficacy (Be-SLE) analysis pooled data from five international Phase 3, randomized, placebo (PBO)-controlled BEL trials (BLISS-52 [NCT00424476; conducted in 2007-2009], BLISS-76 [NCT00410384; 2007-2009], BLISS-SC [NCT01484496; 2011-2015], North East Asia [NCT01345253; 2011-2015], EMBRACE [NCT01632241; 2013-2018]). Adults with active SLE and Safety of Estrogens in Lupus Erythematosus National Assessment-SLE Disease Activity Index (SELENA-SLEDAI) score ≥6 (BLISS-52, BLISS-76) or ≥8 (BLISS-SC, North East Asia, EMBRACE), randomized to BEL (10 mg/kg/month intravenously or 200 mg/week subcutaneously) or PBO, plus standard therapy (ST) were included. Mucocutaneous and vasculitis manifestations (listed below) were measured (baseline and every 4 weeks) for 52 weeks using SELENA-SLEDAI and British Isles Lupus Assessment Group (BILAG).ResultsOf 3086 patients (BEL,

Indexed as

Antibodies, Monoclonal, HumanizedImmunosuppressive AgentsLupus Erythematosus, SystemicVasculitisAdultFemaleHumansMaleMiddle AgedRandomized Controlled Trials as TopicSeverity of Illness IndexTreatment OutcomeAntibodies, Monoclonal, HumanizedbelimumabImmunosuppressive AgentsCutaneous lupussubacute lupus erythematosussystemic lupus erythematosusvasculitis

Identifiers

PMID40322925
PMCPMC12141769

What OpenQuestion holds

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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.