Evidence map›Paper›PMID 29671280›Full record

Trial reportArthritis & rheumatology (Hoboken, N.J.)2018

Efficacy and Safety of Subcutaneous Belimumab in Anti-Double-Stranded DNA-Positive, Hypocomplementemic Patients With Systemic Lupus Erythematosus.

A Doria, W Stohl, A Schwarting, M Okada, M Scheinberg, R van Vollenhoven, A E Hammer, J Groark, D Bass, N L Fox and 2 more

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

Trial report in Arthritis & rheumatology (Hoboken, N.J.), 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01484496 (A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab), which is not on this map. Cited by 37 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed, 1 pooled it
6.5field-weighted citation impact, top 3% 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.

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

37 citing papers in PubMed, 1 synthesis or guideline pooled it, 60 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Redefining Regulatory Proof: The End of the Two-Trial Paradigm.Fundamental & clinical pharmacology · 2026
    Review
  6. Article
  7. Review
  8. Lessons Learnt from the Belimumab Trials in Systemic Lupus Erythematosus.International journal of molecular sciences · 2025
    Review
  9. Review
  10. Review
  11. Article
  12. Review
  13. Article
  14. Review
  15. Article
  16. Review
  17. Review
  18. Review
  19. 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

12 authors at 6 institutions in 4 countries.

A DoriaUniversity of Padua, Padua, Italy.
W StohlUniversity of Southern California, Los Angeles.
A SchwartingUniversity Medical Center of Johannes Gutenberg University, Mainz, Germany.
M OkadaSt. Luke's International University, Tokyo, Japan.
M ScheinbergRheumatology Hospital Abreu Sodre, São Paulo, Brazil.
R van VollenhovenAmsterdam Rheumatology and Immunology Center, Amsterdam, The Netherlands.
A E HammerGlaxoSmithKline, Research Triangle Park, North Carolina.
J GroarkGlaxoSmithKline, Collegeville, Pennsylvania.
D BassGlaxoSmithKline, Collegeville, Pennsylvania.
N L FoxGlaxoSmithKline, Rockville, Maryland.
D RothGlaxoSmithKline, Collegeville, Pennsylvania.
D GordonGlaxoSmithKline, Collegeville, Pennsylvania.
GlaxoSmithKline (United States) · USJohannes Gutenberg University Mainz · DEResearch Triangle Park Foundation · USSt. Luke's International University · JPUniversity of Padua · ITUniversity of Southern California · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo investigate the efficacy and safety of belimumab, a human immunoglobulin monoclonal antibody against B lymphocyte stimulator, in a subset of patients with systemic lupus erythematosus (SLE) who were hypocomplementemic (C3 <90 mg/dl and/or C4 <10 mg/dl) and anti-double-stranded DNA (anti-dsDNA) positive (≥30 IU/ml) at baseline.

methodsIn this phase III, double-blind, placebo-controlled study (BEL112341; ClinicalTrials.gov identifier: NCT01484496), patients with moderate to severe SLE (Safety of Estrogens in Lupus Erythematosus National Assessment version of the Systemic Lupus Erythematosus Disease Activity Index [SELENA-SLEDAI] score ≥8) were randomized (2:1) to receive weekly subcutaneous (SC) belimumab 200 mg or placebo, plus standard SLE therapy, for 52 weeks. The primary end point was SLE Responder Index 4 (SRI-4) response rate at week 52. Secondary end points were time to severe flare and reduction in corticosteroid dose (weeks 40-52). Safety was assessed throughout.

resultsOf the 836 patients in the intent-to-treat (ITT) population, 356 were hypocomplementemic and anti-dsDNA positive at baseline (108 in the placebo group and 248 in the SC belimumab 200 mg group). Compared with placebo, the belimumab group contained more SRI-4 responders (47.2% versus 64.6%; P = 0.0014), had a lower incidence of severe flare according to the SELENA-SLEDAI flare index (31.5% versus 14.1%), and had a greater percentage of patients who reduced corticosteroid dosage by ≥25% to ≤7.5 mg/day during weeks 40-52 (11.4% versus 20.7%; P = 0.0844). Adverse events (AEs) were similar between treatment groups.

conclusionOur findings indicate that in hypocomplementemic, anti-dsDNA-positive SLE patients, weekly SC belimumab 200 mg significantly improves SRI-4 response, decreases severe flare incidence, and reduces corticosteroid use versus placebo; a trend toward greater benefit compared with the overall ITT population was observed. AEs were consistent with the known safety profile of belimumab.

Indexed as

AdultAntibodies, AntinuclearAntibodies, Monoclonal, HumanizedComplement C3DNADouble-Blind MethodFemaleHumansInjections, SubcutaneousIntention to Treat AnalysisLupus Erythematosus, SystemicMaleSeverity of Illness IndexTreatment OutcomeAntibodies, AntinuclearAntibodies, Monoclonal, HumanizedbelimumabComplement C3DNA

Identifiers

PMID29671280
PMCPMC6099508
OpenAlexW2801549351

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.