Evidence map›Paper›PMID 29661905›Full record

Trial reportNeurology2018

Randomized study of adjunctive belimumab in participants with generalized myasthenia gravis.

Karen Hewett, Donald B Sanders, Richard A Grove, Christine L Broderick, Todd J Rudo, Ashlyn Bassiri, Marina Zvartau-Hind, Vera Bril, BEL115123 Study Group

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Neurology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01480596 (A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamics of Belimumab in Subjects With Generalized Myasthenia Gravis), which is not on this map. Cited by 74 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
74citing papers in PubMed, 7 pooled it
7.5field-weighted citation impact, top 2% 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.

NCT01480596 phase2completednot on this map

A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamics of Belimumab in Subjects With Generalized Myasthenia Gravis (MG)

TypeinterventionalSponsorGlaxoSmithKlineRan2013 to 2015Enrolled40ConditionsMyasthaenia GravisArmsBelimumab, Placebo
3 · Its place in the literature

Who cites it

74 citing papers in PubMed, 7 syntheses or guidelines pooled it, 126 citations in OpenAlex.

  1. Pooled it
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  12. Article
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  14. Circulating inflammatory proteins as pathogenic mediators and potential therapeutic targets in myasthenia gravis.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2025
    Article
  15. Review
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  17. New and Emerging Biological Therapies for Myasthenia Gravis: A Focussed Review for Clinical Decision-Making.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2025
    Review
  18. Article
  19. Article
  20. Article

14 more citing papers are in PubMed but not listed here.

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

9 authors at 2 institutions in 2 countries.

Karen HewettFrom GSK (K.H.), Stevenage, Herts, UK; Department of Neurology (D.B.S.), Duke University School of Medicine, Durham, NC; GSK (R.A.G.), Uxbridge, Middlesex, UK; GSK (C.L.B., T.J.R., A.B.), Philadelphia, PA; GSK (M.Z.-H.), Brentford, London, UK; and University Health Network (V.B.), University of Toronto, Canada.
Donald B SandersFrom GSK (K.H.), Stevenage, Herts, UK; Department of Neurology (D.B.S.), Duke University School of Medicine, Durham, NC; GSK (R.A.G.), Uxbridge, Middlesex, UK; GSK (C.L.B., T.J.R., A.B.), Philadelphia, PA; GSK (M.Z.-H.), Brentford, London, UK; and University Health Network (V.B.), University of Toronto, Canada.
Richard A GroveFrom GSK (K.H.), Stevenage, Herts, UK; Department of Neurology (D.B.S.), Duke University School of Medicine, Durham, NC; GSK (R.A.G.), Uxbridge, Middlesex, UK; GSK (C.L.B., T.J.R., A.B.), Philadelphia, PA; GSK (M.Z.-H.), Brentford, London, UK; and University Health Network (V.B.), University of Toronto, Canada.
Christine L BroderickFrom GSK (K.H.), Stevenage, Herts, UK; Department of Neurology (D.B.S.), Duke University School of Medicine, Durham, NC; GSK (R.A.G.), Uxbridge, Middlesex, UK; GSK (C.L.B., T.J.R., A.B.), Philadelphia, PA; GSK (M.Z.-H.), Brentford, London, UK; and University Health Network (V.B.), University of Toronto, Canada.
Todd J RudoFrom GSK (K.H.), Stevenage, Herts, UK; Department of Neurology (D.B.S.), Duke University School of Medicine, Durham, NC; GSK (R.A.G.), Uxbridge, Middlesex, UK; GSK (C.L.B., T.J.R., A.B.), Philadelphia, PA; GSK (M.Z.-H.), Brentford, London, UK; and University Health Network (V.B.), University of Toronto, Canada.
Ashlyn BassiriFrom GSK (K.H.), Stevenage, Herts, UK; Department of Neurology (D.B.S.), Duke University School of Medicine, Durham, NC; GSK (R.A.G.), Uxbridge, Middlesex, UK; GSK (C.L.B., T.J.R., A.B.), Philadelphia, PA; GSK (M.Z.-H.), Brentford, London, UK; and University Health Network (V.B.), University of Toronto, Canada.
Marina Zvartau-HindFrom GSK (K.H.), Stevenage, Herts, UK; Department of Neurology (D.B.S.), Duke University School of Medicine, Durham, NC; GSK (R.A.G.), Uxbridge, Middlesex, UK; GSK (C.L.B., T.J.R., A.B.), Philadelphia, PA; GSK (M.Z.-H.), Brentford, London, UK; and University Health Network (V.B.), University of Toronto, Canada.
Vera BrilFrom GSK (K.H.), Stevenage, Herts, UK; Department of Neurology (D.B.S.), Duke University School of Medicine, Durham, NC; GSK (R.A.G.), Uxbridge, Middlesex, UK; GSK (C.L.B., T.J.R., A.B.), Philadelphia, PA; GSK (M.Z.-H.), Brentford, London, UK; and University Health Network (V.B.), University of Toronto, Canada. vera.bril@utoronto.ca.
BEL115123 Study Group
University Health Network · CAAge UK · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo investigate the efficacy and safety of belimumab, a fully human immunoglobulin G1λ monoclonal antibody against B-lymphocyte stimulator, in participants with generalized myasthenia gravis (MG) who remained symptomatic despite standard of care (SoC) therapy.

methodsEligible participants with MG were randomized 1:1 to receive IV belimumab 10 mg/kg or placebo in this phase II, placebo-controlled, multicenter, double-blind study (NCT01480596; BEL115123). Participants received SoC therapies throughout the 24-week treatment phase and 12-week follow-up period. The primary efficacy endpoint was mean change from baseline in the Quantitative Myasthenia Gravis (QMG) scale at week 24; safety assessments included the frequency and severity of adverse events (AEs) and serious AEs.

resultsForty participants were randomized (placebo n = 22; belimumab n = 18). The mean change in QMG score from baseline at week 24 was not significantly different for belimumab vs placebo (

conclusionsThe primary endpoint was not met for belimumab in participants with generalized MG receiving SoC. There was no significant difference in mean change in the QMG score at week 24 for belimumab vs placebo. The safety profile of belimumab was consistent with previous systemic lupus erythematosus studies. CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that for participants with generalized MG, belimumab did not significantly improve QMG score compared with placebo.

Indexed as

Activities of Daily LivingAgedAntibodiesAntibodies, Monoclonal, HumanizedDouble-Blind MethodFemaleFollow-Up StudiesHumansImmunosuppressive AgentsInternational CooperationMaleMiddle AgedMyasthenia GravisReceptor Protein-Tyrosine KinasesReceptors, CholinergicTime FactorsAntibodiesAntibodies, Monoclonal, HumanizedbelimumabImmunosuppressive AgentsMUSK protein, humanReceptor Protein-Tyrosine KinasesReceptors, Cholinergic

Identifiers

PMID29661905
PMCPMC5902787
OpenAlexW2791715767

What OpenQuestion holds

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LicenceCC BY-NC-ND
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.