PMID- 35512563
OWN - NLM
STAT- MEDLINE
DCOM- 20220621
LR  - 20220621
IS  - 1878-1705 (Electronic)
IS  - 1567-5769 (Linking)
VI  - 109
DP  - 2022 Aug
TI  - Belimumab combined with standard therapy does not increase adverse effects 
      compared with a control treatment: A systematic review and meta-analysis of 
      randomised controlled trials.
PG  - 108811
LID - S1567-5769(22)00295-8 [pii]
LID - 10.1016/j.intimp.2022.108811 [doi]
AB  - BACKGROUND: The increasing administration of belimumab has demonstrated its 
      biological benefits. Prior meta-analyses have examined the overall adverse events 
      (AEs) associated with belimumab, but such knowledge needs to be updated with a 
      high volume of new trials. However, little is known about the occurrence of AEs 
      associated with different underlying diseases. This study aimed to address the 
      safety of the intravenous (IV) administration of belimumab combined with standard 
      of care (SoC) therapy in Systemic lupus erythematosus (SLE) patients. METHODS: We 
      used PubMed, Embase, and the Cochrane Library to systematically search for 
      randomised controlled trials (RCTs) reporting AEs and specific AEs in SLE 
      patients receiving belimumab and SoC therapy before 30 November 2021. We 
      extracted the data of the eligible studies and calculated pooled risk ratios 
      (RRs) and their 95% confidence intervals (CIs) in SLE patients receiving 
      belimumab and SoC therapy and experiencing various AEs. The main outcomes were as 
      follows: (1) any AEs, any serious AEs (SAEs), and any severe AEs; (2) serious 
      organ specific adverse events; (3) adverse events of special interest (AESIs). 
      RESULTS: Of the 1,621 studies identified, nine RCTs involving 7,974 patients were 
      eligible for the meta-analysis. There were no significant differences between the 
      experimental and control groups in terms of the incident of AEs: AEs (RR = 0.99, 
      95% CI: 0.97-1.02, P = 0.68), SAEs (RR = 0.91, 95% CI: 0.81-1.02, P = 0.09), and 
      severe AEs (RR = 0.92, 95% CI: 0.75-1.14, P = 0.46). The pooled data also showed 
      that there was no significant correlation between five types of SAEs grouped by 
      organ class and the IV belimumab (10 mg/kg) intervention, except for 'infections 
      and infestations' (RR = 0.82, 95% CI: 0.70-0.97, P = 0.02) and 'musculoskeletal 
      and connective tissue disorders' (RR = 0.46, 95% CI: 0.32-0.67, P < 0.0001). In 
      addition, we found no significant association between AESIs and the IV 
      administration of belimumab (10 mg/kg) (all malignancies: RR = 1.53, 95% CI: 
      0.69-3.36, P = 0.3; all post-infusion systemic reactions: RR = 1.05, 95% CI: 
      0.85-1.30, P = 0.63; depression: RR = 1.42, 95% CI: 0.92-2.20, P = 0.11; serious 
      depression: RR = 2.60, 95% CI: 0.85-7.93, P = 0.09; suicide or self-injury: 
      RR = 0.97, 95% CI: 0.48-1.96, P = 0.92; serious suicide or self-injury: 
      RR = 1.26, 95% CI: 0.59-2.70, P = 0.56). CONCLUSIONS: According to the results of 
      the meta-analysis, SLE patients did not have significantly increased risk of 
      experiencing any type of AEs when receiving SoC therapy. Special caution should 
      be exercised during close follow-ups and individual clinical management before 
      drug prescription.
CI  - Copyright (c) 2022 Elsevier B.V. All rights reserved.
FAU - Xu, Ying
AU  - Xu Y
AD  - Institute for Hospital Management, Tsing Hua University, Shenzhen Campus, 
      Shenzhen 518055, Guangdong Province, China.
FAU - Xu, Jia-Wen
AU  - Xu JW
AD  - Institute for Hospital Management, Tsing Hua University, Shenzhen Campus, 
      Shenzhen 518055, Guangdong Province, China.
FAU - Wang, Yan-Jiao
AU  - Wang YJ
AD  - Institute for Hospital Management, Tsing Hua University, Shenzhen Campus, 
      Shenzhen 518055, Guangdong Province, China.
FAU - Tung, Tao-Hsin
AU  - Tung TH
AD  - Evidence-based Medicine Centre, Taizhou Hospital of Zhejiang Province Affiliated 
      to Wenzhou Medical University, Linhai 317000, Zhejiang Province, China.
FAU - Chien, Ching-Wen
AU  - Chien CW
AD  - Institute for Hospital Management, Tsing Hua University, Shenzhen Campus, 
      Shenzhen 518055, Guangdong Province, China. Electronic address: 
      ihhca@sz.tsinghua.edu.cn.
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PT  - Review
PT  - Systematic Review
DEP - 20220502
PL  - Netherlands
TA  - Int Immunopharmacol
JT  - International immunopharmacology
JID - 100965259
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 73B0K5S26A (belimumab)
SB  - IM
MH  - Antibodies, Monoclonal, Humanized/adverse effects
MH  - Humans
MH  - Immunotherapy
MH  - *Lupus Erythematosus, Systemic/drug therapy
MH  - Randomized Controlled Trials as Topic
MH  - *Standard of Care
OTO - NOTNLM
OT  - Adverse event
OT  - Belimumab
OT  - Meta-analysis
OT  - Systemic lupus erythematosus
EDAT- 2022/05/06 06:00
MHDA- 2022/06/22 06:00
CRDT- 2022/05/05 18:21
PHST- 2022/02/10 00:00 [received]
PHST- 2022/04/04 00:00 [revised]
PHST- 2022/04/25 00:00 [accepted]
PHST- 2022/05/06 06:00 [pubmed]
PHST- 2022/06/22 06:00 [medline]
PHST- 2022/05/05 18:21 [entrez]
AID - S1567-5769(22)00295-8 [pii]
AID - 10.1016/j.intimp.2022.108811 [doi]
PST - ppublish
SO  - Int Immunopharmacol. 2022 Aug;109:108811. doi: 10.1016/j.intimp.2022.108811. Epub 
      2022 May 2.