title: Efficacy and Safety of Belimumab Plus Standard Therapy in Patients With Systemic Lupus Erythematosus: A Meta-analysis.
abstract: OBJECTIVE
  The treatment of belimumab plus standard therapy in patients with systemic lupus erythematosus (SLE) has been studied extensively in recent years. Our aim was to estimate the efficacy and safety of this therapy compared with placebo plus standard therapy in patients with SLE.
  
  
  METHODS
  PubMed, Web of Science, Embase, Chinese Biomedical Literature Database (CBM, Chinese), and Wanfang Database (Chinese) were searched for all randomized clinical trials that mainly studied the efficacy and safety of belimumab plus standard therapy before June 2015. We extracted or calculated the rate of the SLE Response Index and adverse event rate at 52 weeks in all the included studies. The odds ratio (OR) with 95% CI between the 2 groups in this meta-analysis was conducted by using a random-effects model. Sensitivity and publication bias analyses were also performed. All statistical tests were performed by using Stata software version 12.0 (StataCorp., College Station, Texas).
  
  
  RESULTS
  In the overall samples (4 studies, N = 4692 ), a significantly higher SLE Response Index rate at 52 weeks was found in belimumab plus standard therapy group compared with the placebo plus standard therapy group in all studies (OR = 1.49; 95% CI, 1.26-1.77 ; P < 0.001 ). When assessed with the incidence of serious adverse events, the data revealed that there was no significant difference between the 2 groups, with pooled OR = 1.08; 95% CI, 0.83-1.39; P = 0.573; OR = 1.23; 95% CI, 1.02-1.48; P = 0.029; and OR = 1.07; 95% CI, 0.88-1.29; P = 0.506.
  
  
  CONCLUSIONS
  The results suggest that treatment with belimumab plus standard therapy is more effective than placebo plus standard therapy in SLE patients, which represents major progress in the treatment of SLE. Regardless of the statistical analyses, further research is necessary to optimize treatment effects.
authors.affiliation: Department of Clinical Laboratory, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China.
authors.forename: Li-Qiang
authors.initials: LQ
authors.lastname: Wei
authors.affiliation: Zhengzhou Central Hospital Affiliated with Zhengzhou University, Zhengzhou, Henan, China.
authors.forename: Yong-Gang
authors.initials: YG
authors.lastname: Liang
authors.affiliation: Department of Clinical Laboratory, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China.
authors.forename: Yong
authors.initials: Y
authors.lastname: Zhao
authors.affiliation: Red Cross Blood Center of He'nan Province, Zhengzhou, Henan, China.
authors.forename: Hui-Tao
authors.initials: HT
authors.lastname: Liang
authors.affiliation: Department of Clinical Laboratory, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China. Electronic address: qindongchun2011@126.com.
authors.forename: Dong-Chun
authors.initials: DC
authors.lastname: Qin
authors.affiliation: Department of Clinical Laboratory, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China.
authors.forename: Ming-Cong
authors.initials: MC
authors.lastname: She
mesh_terms: D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D008180:Lupus Erythematosus, Systemic / Q000188:drug therapy*; D016032:Randomized Controlled Trials as Topic; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; C511911:belimumab
keywords: adverse event; belimumab; meta-analysis; systemic lupus erythematosus