Evidence map›Paper›PMID 42570058›Full record

ArticleRheumatology and therapy2026

Subcutaneous Belimumab Demonstrates Consistent Steady-State Pharmacokinetics and is Well Tolerated in Paediatric Patients with SLE in China: An Open-Label Study.

Caifeng Li, Junmei Zhang, Meiping Lu, Haiguo Yu, Li Sun, Qihua Feng, Zhihui Li, Jane Chen, Tiantian Liu, Junyi Wu and 2 more

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Rheumatology and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05917288 (A Multi-Centre, Open-Label Study to Evaluate the Pharmacokinetics and Safety of Subcutaneously Administered Belimumab Plus Standard Therapy in Chinese Pediatric Participants With Systemic Lupus Erythematosus), which is not on this map. Not yet cited in PubMed.

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

NCT05917288 phase1completednot on this map

A Multi-Centre, Open-Label Study to Evaluate the Pharmacokinetics and Safety of Subcutaneously Administered Belimumab Plus Standard Therapy in Chinese Pediatric Participants With Systemic Lupus Erythematosus (SLE)

TypeinterventionalSponsorGlaxoSmithKlineRan2023 to 2024Enrolled16ConditionsSystemic Lupus ErythematosusArmsBelimumab, Standard of care
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

Caifeng LiDepartment of Rheumatology, Beijing Children's Hospital, Capital Medical University, NO. 56 Nanlishi Road, Beijing, 100045, China. caifeng_li@yeah.net.
Junmei ZhangDepartment of Rheumatology, Beijing Children's Hospital, Capital Medical University, NO. 56 Nanlishi Road, Beijing, 100045, China.
Meiping LuDepartment of Rheumatology and Immunology, Children's Hospital of Zhejiang University College of Medicine, Hangzhou, Zhejiang, China.
Haiguo YuRheumatology and Immunology Department, Children's Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.
Li SunNephropathy Rheumatology Department, Children's Hospital of Fudan University, Shanghai, China.
Qihua FengRheumatology and Immunology Department, Children's Hospital of Soochow University, Suzhou, Jiangsu, China.
Zhihui LiNephropathy, Rheumatology and Immunology Department, Hunan Children's Hospital, Changsha, Hunan, China.
Jane ChenChina R&D, GSK, Shanghai, China.
Tiantian LiuChina R&D, GSK, Shanghai, China.
Junyi WuChina R&D, GSK, Shanghai, China.
Xuan ZhouChina R&D, GSK, Shanghai, China.
Haomin QiuChina R&D, GSK, Shanghai, China.

Funding

GSK Study 217091
6 · The paper itself

Abstract

introductionThis study assessed pharmacokinetics and safety of subcutaneous (SC) belimumab in Chinese paediatric patients with systemic lupus erythematosus (cSLE) who previously received intravenous (IV) belimumab; only the IV form is approved for cSLE in China.

methodsThis single-arm, open-label, 12-week bridging study (GSK Study 217091) characterised belimumab 200 mg SC exposure in Chinese paediatric patients (5-17 years) with cSLE who completed the 48-week IV belimumab Phase 4 trial (GSK Study 213560). Safety and tolerability of SC belimumab on-treatment and in a 16-week follow-up period were also assessed. Patients were categorised based on weight; data were summarised using descriptive statistics.

resultsOverall, 16 patients were enrolled (≥ 15- < 30 kg, n = 1; ≥ 30- < 50 kg, n = 5; ≥ 50 kg, n = 10) with a mean age of 12.9 years. The geometric mean approximate C

conclusionSC belimumab demonstrated expected steady-state exposure and tolerability in Chinese paediatric patients with SLE, supporting its use in this patient population.

trial registrationGSK Study 217091; NCT05917288.

Indexed as

BelimumabBiological productsLupus erythematosusPaediatricsPharmacokineticsSubcutaneous injectionsSystemic

Identifiers

PMID42570058
PMCPMC13623809

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Registered trials

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