Evidence map›Paper›PMID 33404659›Full record

ArticleRheumatology (Oxford, England)2021

Contribution of abnormal BMI to adverse health-related quality of life outcomes after a 52-week therapy in patients with SLE.

Alexander Borg, Alvaro Gomez, Arvid Cederlund, Flordelyn Cobar, Victor Qiu, Julius Lindblom, Sharzad Emamikia, Yvonne Enman, Susanne Pettersson, Ioannis Parodis

2 registry-linked trialsOpen access · bronzeAbstract read
In one paragraph

Article in Rheumatology (Oxford, England), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
1.3field-weighted citation impact, top 19% 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
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 1 synthesis or guideline pooled it, 20 citations in OpenAlex.

  1. Pooled it
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  5. Lessons Learnt from the Belimumab Trials in Systemic Lupus Erythematosus.International journal of molecular sciences · 2025
    Review
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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

10 authors at 1 institution in 1 country.

Alexander BorgDivision of Rheumatology, Department of Medicine Solna, Karolinska Institutet.
Alvaro GomezDivision of Rheumatology, Department of Medicine Solna, Karolinska Institutet.
Arvid CederlundDivision of Rheumatology, Department of Medicine Solna, Karolinska Institutet.
Flordelyn CobarDivision of Rheumatology, Department of Medicine Solna, Karolinska Institutet.
Victor QiuDivision of Rheumatology, Department of Medicine Solna, Karolinska Institutet.
Julius LindblomDivision of Rheumatology, Department of Medicine Solna, Karolinska Institutet.
Sharzad EmamikiaDivision of Rheumatology, Department of Medicine Solna, Karolinska Institutet.
Yvonne EnmanDivision of Rheumatology, Department of Medicine Solna, Karolinska Institutet.
Susanne PetterssonDepartment of Gastroenterology, Dermatology and Rheumatology, Karolinska University Hospital.
Ioannis ParodisDivision of Rheumatology, Department of Medicine Solna, Karolinska Institutet.ORCID 0000-0002-4875-5395
Karolinska University Hospital · SE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo investigate whether abnormal BMI is associated with adverse health-related quality of life (HRQoL) outcome, including severe fatigue, after 52 weeks of standard therapy plus belimumab or placebo in patients with SLE.

methodsWe analysed data from the BLISS-52 (NCT00424476) and BLISS-76 (NCT00410384) trials (n = 1684). Adverse HRQoL was defined as SF-36 scores ≤ the fifth percentile in age- and sex-matched US population-based subjects, and FACIT-F scores <30. We compared BMI groups using the Pearson's χ2 test, and assessed independence with multivariable logistic regression analysis.

resultsOverweight (BMI ≥25 kg/m2) and obese (BMI ≥30 kg/m2) patients showed increased likelihood to exhibit adverse SF-36 physical component summary (OR: 1.8; 95% CI: 1.4, 2.3; P <0.001 and OR: 2.4; 95% CI: 1.8, 3.2; P <0.001, respectively) and FACIT-F (OR: 1.3; 95% CI: 1.1, 1.6; P = 0.010 and OR: 1.5; 95% CI: 1.2, 2.0; P = 0.002, respectively) scores at week 52. Underweight was associated with adverse SF-36 mental component summary scores, also after adjustment for sex, ancestry, age, disease duration, disease activity, organ damage and prednisone dose during the study period (OR: 2.1; 95% CI: 1.2, 3.6; P = 0.007). Addition of belimumab to standard therapy independently protected against adverse SF-36 general health (OR: 0.8; 95% CI: 0.6, 1.0; P = 0.025) and FACIT-F < 30 (OR: 0.8; 95% CI: 0.6, 1.0; P = 0.018).

conclusionOverweight and obesity contributed to adverse physical and mental HRQoL outcomes after therapeutic intervention in SLE patients, and underweight contributed to adverse mental HRQoL outcome. A protective effect of belimumab against adverse general health and severe fatigue was implicated.

Indexed as

AdultAntibodies, Monoclonal, HumanizedBody Mass IndexFemaleHumansImmunosuppressive AgentsLupus Erythematosus, SystemicMaleMiddle AgedOverweightQuality of LifeTreatment OutcomeYoung AdultAntibodies, Monoclonal, HumanizedbelimumabImmunosuppressive Agentshealth-related quality of lifepatient perspectivepatient-reported outcomesSystemic lupus erythematosus

Identifiers

PMID33404659
PMCPMC8410008
OpenAlexW3119123020

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.