PMID- 29995817
OWN - NLM
STAT- MEDLINE
DCOM- 20180727
LR  - 20210109
IS  - 1536-5964 (Electronic)
IS  - 0025-7974 (Print)
IS  - 0025-7974 (Linking)
VI  - 97
IP  - 28
DP  - 2018 Jul
TI  - Clinical adverse effects of natalizumab: Protocol for a meta-analysis of 
      randomized double-blind placebo-controlled clinical trails.
PG  - e11507
LID - 10.1097/MD.0000000000011507 [doi]
LID - e11507
AB  - BACKGROUND: Natalizumab (NAT), a humanized monoclonal antibody, which binds in 
      both alpha4beta1 integrins and alpha4beta7 integrins, is approved for the treatment of multiple 
      sclerosis (MS) and Crohn's disease (CD). An uncommon but serious adverse event 
      from NAT treatment is known as progressive multifocal leukoencephalopathy (PML). 
      However, clinical comprehensive safety evidence of NAT is limited. METHODS: We 
      will search Medline, Embase, Cochrane library, and ClinicalTrials.gov website 
      from inception to May 9, 2018. Double-blind, randomized placebo-controlled trials 
      reporting safety data of NAT will be eligible for inclusion. Outcome variables 
      will include adverse events (AEs) varying degrees and AEs occurring in >/= 5% 
      patients with NAT or placebo. STATA software (version 12, Statacorp, College 
      Station, TX) will be utilized to assess risk of bias and synthesize data. 
      Outcomes will be reported by weight mean difference (WMD), risk ratios (RRs), and 
      their 95% confidence intervals (95% CIs). I statistic will be used to evaluate 
      heterogeneity among studies. RESULTS: This systemic review and meta-analysis will 
      evaluate serious AEs and AEs of NAT as compared to placebo. CONCLUSION: Our study 
      will provide a comprehensive picture of AEs of NAT.
FAU - Li, Hao
AU  - Li H
AD  - Department of Pharmacy, Shanghai Children's Medical Center, Shanghai Jiao Tong 
      University School of Medicine Department of Pharmacy, Renji Hospital, School of 
      Medicine, Shanghai Jiao Tong University, Shanghai Research Division of Clinical 
      Pharmacology, the First Affiliated Hospital of Nanjing Medical University, 
      Nanjing, Jiangsu, People's Republic of China.
FAU - Shi, Fang-Hong
AU  - Shi FH
FAU - Huang, Shi-Ying
AU  - Huang SY
FAU - Zhang, Shun-Guo
AU  - Zhang SG
FAU - Gu, Zhi-Chun
AU  - Gu ZC
FAU - Wei, Ji-Fu
AU  - Wei JF
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PT  - Review
PL  - United States
TA  - Medicine (Baltimore)
JT  - Medicine
JID - 2985248R
RN  - 0 (Immunologic Factors)
RN  - 0 (Natalizumab)
SB  - IM
MH  - Crohn Disease/*drug therapy
MH  - Double-Blind Method
MH  - Humans
MH  - Immunologic Factors/*adverse effects
MH  - Multiple Sclerosis/*drug therapy
MH  - Natalizumab/*adverse effects
MH  - Randomized Controlled Trials as Topic
PMC - PMC6076155
COIS- The authors declare no conflicts of interest.
EDAT- 2018/07/12 06:00
MHDA- 2018/07/28 06:00
PMCR- 2018/07/13
CRDT- 2018/07/12 06:00
PHST- 2018/07/12 06:00 [entrez]
PHST- 2018/07/12 06:00 [pubmed]
PHST- 2018/07/28 06:00 [medline]
PHST- 2018/07/13 00:00 [pmc-release]
AID - 00005792-201807130-00068 [pii]
AID - MD-D-18-04075 [pii]
AID - 10.1097/MD.0000000000011507 [doi]
PST - ppublish
SO  - Medicine (Baltimore). 2018 Jul;97(28):e11507. doi: 10.1097/MD.0000000000011507.