Infectious complications of Belimumab with standard care in systemic lupus erythematosus: a systematic review and meta-analysis

IF 4.6 2区医学 Q1 RHEUMATOLOGY

Seminars in arthritis and rheumatism Pub Date : 2025-05-14 DOI:10.1016/j.semarthrit.2025.152754

Yu Zhao , Gerald Chi , Shujun Xia , Xinchang Wang , Yongsheng Fan , Chenhang Ma , James Cheng-Chung Wei , Weijie Wang

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Abstract

Objectives

We aimed to evaluate the risk of infectious complications of Belimumab with standard care in systemic lupus erythematosus (SLE).

Methods

We searched PubMed, Web of Science, EMBASE, and Cochrane databases for studies on SLE and Belimumab and evaluated the study quality using the Cochrane Collaboration tool (ROB 2). A random-effect model was employed to analyze the results. To evaluate publication bias, Egger's tests were used. We also performed subgroup analysis based on the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) and British Isles Lupus Assessment Group(BILAG). The study protocol has been registered in PROSPERO (CRD42023421255).

Results

Eight studies involving 8545 patients were included, of which four studies had a high attrition bias. The present study suggested that the risks of infectious complications including infection (RR=1.02, 95 %CI=(0.97,1.08), I²=7.7 %) or serious infections (RR=0.94, 95 %CI=(0.77,1.15), I²=0 %), nasopharyngitis(RR=1.02, 95 %CI=(0.79,1.33), I²=36 %), upper respiratory tract infection(RR=0.97, 95 %CI=(0.83,1.14), I²=20.6 %), urinary tract infection(RR=1.09, 95 %CI=(0.91,1.32), I²=0 %), herpes zoster (RR=0.75, 95 %CI=(0.54,1.05), I²=0 %)and influenza(RR=0.98, 95 %CI=(0.69,1.39), I²=0 %) were not significantly increased in patients who received Belimumab with standard care, except for bronchitis (RR=1.51, 95 %CI=(0.98,2.33), I²=23.7 %). Additionally, the subgroup analysis of SLEDAI and the proportion of patients with BILAG 1A/2B did not show any significant impact on infectious complications.

Conclusion

Meta-analysis results demonstrated that intravenous (IV) Belimumab(≤10 mg/kg), along with standard care, did not significantly increase the risk of infectious complications in SLE patients having mild-to-moderate disease activity, except for bronchitis. Baseline disease activity and organ damage did not impact the risk of infectious complications.

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bellimumab标准治疗系统性红斑狼疮的感染并发症：系统回顾和荟萃分析

目的：我们旨在评估标准治疗系统性红斑狼疮（SLE）的Belimumab感染并发症的风险。方法我们检索PubMed、Web of Science、EMBASE和Cochrane数据库，检索SLE和Belimumab的研究，并使用Cochrane协作工具（ROB 2）评估研究质量。采用随机效应模型对结果进行分析。为了评估发表偏倚，我们使用了Egger检验。我们还基于系统性红斑狼疮疾病活动指数（SLEDAI）和不列颠群岛狼疮评估组（BILAG）进行了亚组分析。该研究方案已在PROSPERO注册（CRD42023421255）。结果纳入8项研究，共8545例患者，其中4项研究存在高消耗偏倚。目前的研究表明感染性并发症包括感染的风险(RR = 1.02, 95% CI = (0.97, 1.08), I2 = 7.7%)或严重感染(RR = 0.94, 95% CI = (0.77, 1.15), I2 = 0%),鼻咽炎(RR = 1.02, 95% CI = (0.79, 1.33), I2 = 36%),上呼吸道感染(RR = 0.97, 95% CI = (0.83, 1.14), I2 = 20.6%),尿路感染(RR = 1.09, 95% CI = (0.91, 1.32), I2 = 0%),带状疱疹(RR = 0.75, 95% CI = (0.54, 1.05), I2 = 0%)和流感(RR = 0.98, 95% CI = (0.69, 1.39),I2= 0%)在接受bellimumab标准治疗的患者中没有显著增加，除了支气管炎（RR=1.51, 95% CI=(0.98,2.33), I2= 23.7%）。此外，SLEDAI的亚组分析和BILAG 1A/2B患者比例未显示对感染并发症有显著影响。荟萃分析结果显示，静脉注射（IV） Belimumab（≤10 mg/kg）以及标准护理并未显著增加轻度至中度疾病活动度的SLE患者感染并发症的风险，支气管炎除外。基线疾病活动度和器官损害不影响感染性并发症的风险。

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来源期刊

Seminars in arthritis and rheumatism 医学-风湿病学

CiteScore

9.20

自引率

4.00%

发文量

176

审稿时长

46 days

期刊介绍： Seminars in Arthritis and Rheumatism provides access to the highest-quality clinical, therapeutic and translational research about arthritis, rheumatology and musculoskeletal disorders that affect the joints and connective tissue. Each bimonthly issue includes articles giving you the latest diagnostic criteria, consensus statements, systematic reviews and meta-analyses as well as clinical and translational research studies. Read this journal for the latest groundbreaking research and to gain insights from scientists and clinicians on the management and treatment of musculoskeletal and autoimmune rheumatologic diseases. The journal is of interest to rheumatologists, orthopedic surgeons, internal medicine physicians, immunologists and specialists in bone and mineral metabolism.