Open AccessClinical adverse effects of natalizumab
Author(s) -
Hao Li,
Fang-Hong Shi,
Shiying Huang,
Shunguo Zhang,
Gu Z,
JiFu Wei
Publication year - 2018
Publication title -
medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.59
H-Index - 148
eISSN - 1536-5964
pISSN - 0025-7974
DOI - 10.1097/md.0000000000011507
Subject(s) - medicine , natalizumab , adverse effect , placebo , cochrane library , nat , medline , progressive multifocal leukoencephalopathy , clinical trial , meta analysis , multiple sclerosis , disease , immunology , pathology , alternative medicine , political science , law , computer network , computer science
Background: Natalizumab (NAT), a humanized monoclonal antibody, which binds in both α 4 β 1 integrins and α 4 β 7 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 2 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.