PMID- 37181426
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230920
IS  - 2296-2360 (Print)
IS  - 2296-2360 (Electronic)
IS  - 2296-2360 (Linking)
VI  - 11
DP  - 2023
TI  - Adverse events in the treatment of spinal muscular atrophy in children and 
      adolescents with nusinersen: A systematic review and meta-analysis.
PG  - 1152318
LID - 10.3389/fped.2023.1152318 [doi]
LID - 1152318
AB  - OBJECTIVES: To systematically analyze adverse events (AEs) in treatment of spinal 
      muscular atrophy (SMA) with Nusinersen in children and adolescents. METHODS: The 
      study is registered on PROSPERO (CRD42022345589). Databases were searched and 
      literature relating to Nusinersen in the treatment of spinal muscular atrophy in 
      children from the start of database establishment to December 1, 2022, was 
      retrospectively analyzed. R.3.6.3 statistical software was used, and random 
      effects meta-analysis was performed to calculate weighted mean prevalence and 95% 
      confidence intervals (CI). RESULTS: In total, 15 eligible studies were included, 
      with a total of 967 children. Rate of definite Nusinersen-related AEs was 0.57% 
      (95% CI: 0%-3.97%), and probable Nusinersen-related AEs 7.76% (95% CI: 
      1.85%-17.22%). Overall rate of AEs was 83.51% (95% CI: 73.55%-93.46%), and 
      serious AEs 33.04% (95% CI: 18.15%-49.91%). For main specific AEs, fever was most 
      common, 40.07% (95% CI: 25.14%-56.02%), followed by upper respiratory tract 
      infection 39.94% (95% CI: 29.43%-50.94%), and pneumonia 26.62% (95% CI: 
      17.99%-36.25%).The difference in overall AE rates between the two groups 
      (Nusinersen group and placebo group) was significant (OR = 0.27,95% CI: 
      0.08-0.95, P = 0.042). Moreover, incidence of serious adverse events, and fatal 
      adverse events were both significantly lower than in the placebo group 
      (OR = 0.47, 95%CI: 0.32-0.69, P < 0.01), and (OR = 0.37, 95%CI: 0.23-0.59, 
      P < 0.01), respectively. CONCLUSION: Nusinersen direct adverse events are rare, 
      and it can effectively reduces common, serious, and fatal adverse events in 
      children and adolescents with spinal muscular atrophy.
CI  - (c) 2023 Zhong, Zheng, Dou and Wang.
FAU - Zhong, Zhi-Juan
AU  - Zhong ZJ
AD  - Department of Pediatrics, Hainan General Hospital, Hainan Affiliated Hospital of 
      Hainan Medical University, Haikou, China.
FAU - Zheng, Pi-Mei
AU  - Zheng PM
AD  - Department of Pediatrics, Hainan General Hospital, Hainan Affiliated Hospital of 
      Hainan Medical University, Haikou, China.
FAU - Dou, Hui-Hong
AU  - Dou HH
AD  - Department of Pediatrics, Guangxi Clinical Research Center for Pediatric 
      Diseases, Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region, 
      Nanning, China.
FAU - Wang, Ji-Gan
AU  - Wang JG
AD  - Department of Pediatrics, Guangxi Clinical Research Center for Pediatric 
      Diseases, Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region, 
      Nanning, China.
LA  - eng
PT  - Journal Article
PT  - Review
DEP - 20230425
PL  - Switzerland
TA  - Front Pediatr
JT  - Frontiers in pediatrics
JID - 101615492
PMC - PMC10167028
OTO - NOTNLM
OT  - AES
OT  - SMA
OT  - meta
OT  - nusinersen
OT  - spinal muscular atrophy
COIS- The authors declare that the research was conducted in the absence of any 
      commercial or financial relationships that could be construed as a potential 
      conflict of interest.
EDAT- 2023/05/14 19:13
MHDA- 2023/05/14 19:14
PMCR- 2023/04/25
CRDT- 2023/05/14 12:18
PHST- 2023/01/27 00:00 [received]
PHST- 2023/04/07 00:00 [accepted]
PHST- 2023/05/14 19:13 [pubmed]
PHST- 2023/05/14 19:14 [medline]
PHST- 2023/05/14 12:18 [entrez]
PHST- 2023/04/25 00:00 [pmc-release]
AID - 10.3389/fped.2023.1152318 [doi]
PST - epublish
SO  - Front Pediatr. 2023 Apr 25;11:1152318. doi: 10.3389/fped.2023.1152318. 
      eCollection 2023.