Evidence map›Paper›PMID 29295825›Full record

Trial reportAnnals of the rheumatic diseases2018

A pivotal phase III, randomised, placebo-controlled study of belimumab in patients with systemic lupus erythematosus located in China, Japan and South Korea.

Fengchun Zhang, Sang-Cheol Bae, Damon Bass, Myron Chu, Sally Egginton, David Gordon, David A Roth, Jie Zheng, Yoshiya Tanaka

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of the rheumatic diseases, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01345253 (GSK1550188 A 52 Week Study of Belimumab Versus Placebo in the Treatment of Subjects With Systemic Lupus Erythematosus), which is not on this map. Cited by 168 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
168citing papers in PubMed, 13 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.

NCT01345253 phase3completednot on this map

GSK1550188 A 52 Week Study of Belimumab Versus Placebo in the Treatment of Subjects With Systemic Lupus Erythematosus (SLE) Located in Northeast Asia

TypeinterventionalSponsorGlaxoSmithKlineRan2011 to 2018Enrolled709ConditionsSystemic Lupus ErythematosusArmsBelimumab, Placebo
3 · Its place in the literature

Who cites it

168 citing papers in PubMed, 13 syntheses or guidelines pooled it.

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  11. Belimumab for systemic lupus erythematosus.The Cochrane database of systematic reviews · 2021
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108 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.

Fengchun ZhangDepartment of Rheumatology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Sang-Cheol BaeDepartment of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, Korea.
Damon BassGlaxoSmithKline, Philadelphia, Pennsylvania, USA.
Myron ChuGlaxoSmithKline, Philadelphia, Pennsylvania, USA.
Sally EggintonGlaxoSmithKline, Stevenage, UK.
David GordonGlaxoSmithKline, Philadelphia, Pennsylvania, USA.
David A RothGlaxoSmithKline, Philadelphia, Pennsylvania, USA.
Jie ZhengDepartment of Dermatology, Ruijin Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.
Yoshiya TanakaThe First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIntravenous belimumab plus standard of care (SoC) is approved in the USA and Europe for treatment of active, autoantibody-positive systemic lupus erythematosus (SLE).

methodsThis phase III, multicentre, randomised, double-blind, placebo-controlled study (BEL113750; NCT01345253) was conducted in 49 centres across China, Japan and South Korea (May 2011

resultsThe modified intent-to-treat population included 677 patients (belimumab n=451, placebo n=226). At Week 52, the SRI4 response rate was higher with belimumab versus placebo (53.8% vs 40.1%; OR: 1.99 (95% CI: 1.40, 2.82; P=0.0001)). The percentages of patients with a ≥4 point reduction in SELENA-SLEDAI and an SRI7 response were significantly greater for belimumab versus placebo. Patients in the belimumab group had a 50% lower risk of experiencing a severe flare than those receiving placebo (P=0.0004). In patients with baseline prednisone dose >7.5 mg/day, there was a significant reduction in steroid use favouring belimumab (P=0.0228). The incidence of adverse events was similar between groups.

conclusionsIn patients with SLE from North East Asia, belimumab significantly improved disease activity, while reducing prednisone use, with no new safety issues.

Indexed as

Administration, IntravenousAdultAntibodies, Monoclonal, HumanizedChinaDouble-Blind MethodFemaleHumansImmunosuppressive AgentsJapanLupus Erythematosus, SystemicMaleMiddle AgedPrednisoneRepublic of KoreaSeverity of Illness IndexStandard of CareAntibodies, Monoclonal, HumanizedbelimumabImmunosuppressive AgentsPrednisoneDisease ActivitySystemic Lupus ErythematosusTreatment

Identifiers

PMID29295825
PMCPMC5867402

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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.