Evidence map›Paper›PMID 33568389›Full record

Trial reportLupus science & medicine2021

Efficacy of belimumab in two serologically distinct high disease activity subgroups of patients with systemic lupus erythematosus: post-hoc analysis of data from the phase III programme.

Toni Maslen, Ian N Bruce, David D'Cruz, Mihaela Ianosev, Damon L Bass, Christel Wilkinson, David A Roth

3 registry-linked trialsOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Lupus science & medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 pooled it
2.0field-weighted citation impact, top 14% 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
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

10 citing papers in PubMed, 2 syntheses or guidelines pooled it, 16 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Trial
  4. Review
  5. Article
  6. Observational
  7. Lessons Learnt from the Belimumab Trials in Systemic Lupus Erythematosus.International journal of molecular sciences · 2025
    Review
  8. Review
  9. Review
  10. 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

7 authors at 4 institutions in 2 countries.

Toni MaslenUK Health Outcomes, GlaxoSmithKline, London, UK toni.k.maslen@gsk.com.ORCID 0000-0003-3814-9479
Ian N BruceNIHR Manchester Biomedical Research Centre, Manchester University Hospitals NHS Foundation Trust, Manchester, UK.
David D'CruzLouise Coote Lupus Unit, Guy's Hospital, London, UK.
Mihaela IanosevMedical Affairs Europe, GlaxoSmithKline, London, UK.
Damon L BassImmuno-Inflammation and Future Pipeline, GlaxoSmithKline USA, Collegeville, Pennsylvania, USA.
Christel WilkinsonClinical Statistics, GlaxoSmithKline, Stevenage, UK.
David A RothResearch & Development, GlaxoSmithKline USA, Collegeville, Pennsylvania, USA.
GlaxoSmithKline (United Kingdom) · GBGlaxoSmithKline (United States) · USGuy's Hospital · GBManchester Academic Health Science Centre · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo assess the appropriateness of expanded serological activity eligibility criteria for belimumab use in the UK systemic lupus erythematosus (SLE) population (and possibly other countries), which includes patients with either anti-double-stranded DNA (anti-dsDNA) positivity

methodsThis post-hoc analysis used data from three randomised, double-blind, placebo-controlled phase III belimumab trials: BLISS-52 (BEL110752; NCT00424476), BLISS-76 (BEL110751; NCT00410384) and BLISS-SC (BEL112341; NCT01484496). Patients with SLE were stratified by high disease activity (HDA): HDA1, Safety of Estrogens in Lupus Erythematosus National Assessment-SLE Disease Activity Index (SELENA-SLEDAI) score ≥10, low complement

resultsThis analysis included 660 HDA1 patients (n=396 on intravenous treatment; n=264 on subcutaneous treatment) and 969 HDA2 patients (n=532 on intravenous treatment; n=437 on subcutaneous treatment). Significant improvements were observed at week 52 with belimumab versus placebo, irrespective of subgroups or drug formulations, in SLE Responder Index (SRI) 4 response (OR (95% CI): HDA1 intravenous 2.7 (1.8 to 4.1); HDA2 intravenous 2.3 (1.61 to 3.26); HDA1 subcutaneous 2.2 (1.22 to 3.85); HDA2 subcutaneous 1.8 (1.17 to 2.74)); proportion of patients achieving ≥4-point reduction in SELENA-SLEDAI score (OR (95% CI): HDA1 intravenous 2.6 (1.7 to 3.9); HDA2 intravenous 2.1 (1.49 to 3.03); HDA1 subcutaneous 2.3 (1.30 to 4.14); HDA2 subcutaneous 1.9 (1.21 to 2.84)); patients with no worsening in Physician Global Assessment (OR (95% CI): HDA1 intravenous 2.0 (1.3 to 3.1); HDA2 intravenous 1.7 (1.17 to 2.45); HDA1 subcutaneous 2.3 (1.18 to 4.40); HDA2 subcutaneous 1.8 (1.11 to 2.92)); and risk of severe flares (HR (95% CI): HDA1 intravenous 0.6 (0.37 to 0.81); HDA2 intravenous 0.6 (0.43 to 0.86); HDA1 subcutaneous 0.52 (0.30 to 0.92); HDA2 subcutaneous 0.59 (0.37 to 0.94)).

conclusionBroadening the HDA population to include either low complement

Indexed as

Lupus Erythematosus, SystemicAdultAntibodies, Monoclonal, HumanizedFemaleHumansMaleSeverity of Illness IndexTreatment OutcomeAntibodies, Monoclonal, Humanizedbelimumablupus erythematosusquality of lIfesystemictherapeutics

Identifiers

PMID33568389
PMCPMC7878136
OpenAlexW3128259546

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.