Meta-analysis of efficacy and safety of belimumab in the treatment of childhood-onset systemic lupus erythematosus
- VernacularTitle:贝利尤单抗治疗儿童系统性红斑狼疮有效性和安全性的Meta分析
- Author:
Xin YU
1
;
Wensheng ZHAI
1
,
2
;
Mengmeng ZHANG
1
;
Xiangge REN
1
Author Information
1. School of Pediatric Medicine，Henan University of Traditional Chinese Medicine，Zhengzhou 450099，China
2. First Districts of Pediatrics，the First Affiliated Hospital of Henan University of Chinese Medicine，Zhengzhou 450099，China
- Publication Type:Journal Article
- Keywords:
belimumab;
childhood-onset systemic lupus erythematosus;
efficacy;
safety;
meta-analysis
- From:
China Pharmacy
2023;34(16):2003-2007
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To evaluate the efficacy and safety of belimumab in the treatment childhood-onset systemic lupus erythematosus （cSLE）， and to provide evidence-based references for clinical medication. METHODS Randomized controlled trials （RCTs） about belimumab or belimumab combined with hormone or belimumab combined with hormone and traditional drugs （test group） compared with placebo or hormone or traditional drugs or traditional drugs combined with hormone （control group） were collected by computer searching CNKI， Wanfang data， VIP， SinoMed， PubMed， Embase， Web of Science and the Cochrane Library； the search deadline was from the establishment of the databases to April 9th， 2023. After screening the literature and extracting the data， the quality of the included literature was evaluated by using the bias risk assessment tool recommended by Cochrane system evaluation manual 5.1.0； meta-analysis and sensitivity analysis were conducted by using RevMan 5.4 software. RESULTS A total of 510 children were included in 7 RCTs. Results of the meta-analysis showed that the clinically effective rate of test group was significantly better than the control group [OR＝6.16， 95%CI （2.23， 17.00）， P＝0.000 4]. There were no statistically significant differences in SLE disease activity index （SLEDAI） [MD＝－1.73， 95%CI （－3.50， 0.05）， P＝0.06]， the incidence of adverse drug reactions [OR＝0.72， 95%CI （0.43， 1.19）， P＝0.02]， complement C3 levels [MD＝0.12， 95%CI （－0.06， 0.30）， P＝0.18]， complement C4 levels [MD＝0.08，95%CI （－0.07，0.24）， P＝0.30] or the response rate of SLE responder index 4 [OR＝1.52， 95%CI （0.94，2.44）， P＝0.09] between 2 groups. The results of sensitivity analysis showed that when SLEDAI， the complement C3 levels and complement C4 levels were used as indicators， the results obtained in this study were robust. CONCLUSIONS The efficacy of belimumab in the treatment of cSLE is good， and its safety is comparable to the basic treatment.
