• Hao Li, Fang-Hong Shi, Shi-Ying Huang, Shun-Guo Zhang, Zhi-Chun Gu, and Ji-Fu Wei.
• 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.
• Medicine (Baltimore). 2018 Jul 1; 97 (28): e11507e11507.

BackgroundNatalizumab (NAT), a humanized monoclonal antibody, which binds in both α4β1 integrins and α4β7 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.MethodsWe 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.ResultsThis systemic review and meta-analysis will evaluate serious AEs and AEs of NAT as compared to placebo.ConclusionOur study will provide a comprehensive picture of AEs of NAT.

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