Table1_Monoclonal Antibody Therapy in Neuromyelitis Optica Spectrum Disorders: a Meta-analysis of Randomized Control Trials.docx

Background: To update the efficacy and safety data of monoclonal antibodies for the treatment of neuromyelitis optica spectrum disorders (NMOSD) and explore the differences in the effect of treatment between patients seropositive and seronegative for AQP4-IgG. Methods: PubMed, Embase, and the Cochrane Library published up to July 2020 were searched for randomized controlled trials (RCTs) of monoclonal antibodies treatment (mAb) in patients with NMOSD. The primary outcome was the hazard ratio (HR) for relapse. The secondary outcomes included Expanded Disability Status Scale (EDSS) changes from baseline, adverse events (AEs), and serious adverse events (SAEs). A random-effects model was applied for the effect of heterogeneity among trials. Results: We included 603 patients (monoclonal antibody group, n=382, and control group, n=221) from seven RCTs. There were fewer relapses in the mAb group (HR=0.32, 95% CI: 0.23-0.46, p

背景：为更新针对神经节苷脂蛋白O4免疫球蛋白G (AQP4-IgG)阳性和阴性患者的神经节苷脂蛋白O4谱系疾病（NMOSD）治疗的单克隆抗体（mAb）的有效性和安全性数据，并探讨治疗效果在血清阳性和血清阴性患者之间的差异。方法：检索了截至2020年7月PubMed、Embase和Cochrane Library数据库中关于NMOSD患者单克隆抗体治疗的随机对照试验（RCTs）。主要结局指标为复发的风险比（HR）。次要结局指标包括从基线到扩展残疾状况量表（EDSS）的变化、不良事件（AEs）和严重不良事件（SAEs）。对试验之间的异质性效应采用了随机效应模型。结果：纳入了来自七个RCTs的603名患者（单克隆抗体组n=382，对照组n=221）。单克隆抗体组复发的病例较少（HR=0.32，95% CI：0.23-0.46，p值待续）。