Evidence map›Paper›PMID 30320964›Full record

Trial reportArthritis care & research2019

Long-Term Impact of Belimumab on Health-Related Quality of Life and Fatigue in Patients With Systemic Lupus Erythematosus: Six Years of Treatment.

Vibeke Strand, Pamela Berry, Xiwu Lin, Yumi Asukai, Rajesh Punwaney, Sulabha Ramachandran

Registry-linked trialAbstract readClinical TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Arthritis care & research, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00724867 (A Multi-Center, Continuation Trial of Belimumab), which is not on this map. Cited by 28 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 1 pooled it
–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.

NCT00724867 phase3completednot on this map

A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed the Phase 3 Protocol HGS1006-C1056 in the United States

TypeinterventionalSponsorHuman Genome Sciences Inc., a GSK CompanyRan2008 to 2015Enrolled268ConditionsSystemic Lupus ErythematosusArmsBelimumab 1 mg/kg, Belimumab 10 mg/kg
3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Belimumab for systemic lupus erythematosus.The Cochrane database of systematic reviews · 2021
    Pooled it
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  8. Observational
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  20. Genetic Variants of theFrontiers in immunology · 2022
    Article
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

6 authors.

Vibeke StrandStanford University School of Medicine, Palo Alto, California.
Pamela BerryGlaxoSmithKline, Philadelphia, Pennsylvania.
Xiwu LinGlaxoSmithKline, Philadelphia, Pennsylvania.
Yumi AsukaiGlaxoSmithKline, Uxbridge, Middlesex, UK.
Rajesh PunwaneyGlaxoSmithKline, King of Prussia, Pennsylvania.
Sulabha RamachandranGlaxoSmithKline, Philadelphia, Pennsylvania.

Funding

GlaxoSmithKlineHuman Genome Sciences
6 · The paper itself

Abstract

objectiveTo report long-term health-related quality of life (HRQoL) and fatigue outcomes in patients with systemic lupus erythematosus (SLE) receiving belimumab.

methodsPatients with SLE who completed the Study of Belimumab in Subjects with SLE 76-week trial (BLISS-76) were enrolled in this continuation study (BEL112233 [ClinicalTrials.gov identifier: NCT00724867]). The belimumab groups continued to receive the same dose (1 mg/kg or 10 mg/kg) intravenously. After March 2011, all patients received belimumab 10 mg/kg every 28 days plus standard therapy. The placebo group switched to belimumab 10 mg/kg. HRQoL and fatigue assessments included the Short Form 36 (SF-36) health survey and the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue subscale. Post hoc subgroup analyses (BEL206350) assessed clinical characteristics associated with improved HRQoL and fatigue.

resultsOf the 268 patients enrolled, 140 completed the study. Patients receiving long-term belimumab treatment reported continued improvements in HRQoL and fatigue. At study year 6, the mean ± SD SF-36 physical component summary (PCS) score and the mental component summary (MCS) score increased from 37.0 ± 9.9 at baseline to 41.7 ± 10.0 (mean ± SD change 4.8 ± 9.4) and from 44.3 ± 11.3 to 47.0 ± 11.6 (mean ± SD change 2.7 ± 11.3) for the PCS and MCS, respectively, exceeding the minimum clinically important difference (MCID) for improvement (2.5 units). The mean ± SD FACIT-Fatigue score exceeded the MCID of 4 at study years 1-5; at study year 6, the mean ± SD change was 3.7 ± 11.8. Statistically significant associations were observed between parent trial treatment groups and change from baseline in PCS, MCS, and FACIT-Fatigue scores (P < 0.01).

conclusionLong-term control of SLE disease activity with belimumab plus standard therapy translates into meaningful improvements in patient-reported fatigue and HRQoL.

Indexed as

Quality of LifeAdultAntibodies, Monoclonal, HumanizedFatigueFemaleHumansImmunosuppressive AgentsLupus Erythematosus, SystemicMaleMiddle AgedTime FactorsTreatment OutcomeUnited StatesAntibodies, Monoclonal, HumanizedbelimumabImmunosuppressive Agents

Identifiers

PMID30320964
PMCPMC6593666

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.