Department of Neurosurgery & Brain and Nerve Research Laboratory, The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu Province, 215006, China.
Department of General Surgery, Dushuhu Public Hospital Affiliated to Soochow University, Suzhou, Jiangsu Province, 215006, China.
Mult Scler Relat Disord. 2020 Aug;43:102166. doi: 10.1016/j.msard.2020.102166. Epub 2020 May 11.
Neuromyelitis optica spectrum disorders (NMOSD) are autoimmune inflammatory disorders in central nervous system (CNS) characterized by symptoms of optic nerve, spinal cord, brainstem and cerebrum injuries. Recent studies have shown that monoclonal antibodies (Rituximab, Eculizumab, Inebilizumab, Satralizumab, etc.) were effective for the treatment of NMOSD. We performed a meta-analysis to evaluate the efficacy and safety of these monoclonal antibodies in NMOSD.
The MEDLINE, EMBASE, Central Register of Controlled Trials (CENTRAL) and clinicaltrials.gov database were searched for randomized controlled trials (RCTs) which had assessed the therapy of monoclonal antibody in NMOSD patients.
We pooled 524 (monoclonal antibody group, n = 344 and placebo group, n = 180) from 4 RCTs and 444 patients (84.7%) were AQP4-IgG seropositive. Monoclonal antibody therapy reduced annualized relapse rate (mean -0.27, 95% CI, -0.36 to -0.18, P <0.0001), on-trial relapse risk (RR 0.25, 95% CI 0.12 to 0.52, P = 0.0003), EDSS (Expanded disability status scale) score (mean -0.51, 95% CI, -0.92 to -0.11, P = 0.01) and serious adverse events (RR 0.59, 95% CI 0.37 to 0.96, P = 0.03) but didn't show any significant differences in total adverse events or mortality. In the subgroup analysis, we found that comparing with other monoclonal antibodies, Eculizumab might be more effective in decreasing on-trial relapse risk (Chi =9.84, P =0.002) for AQP-4 positive patients.
Monoclonal antibody therapy was effective and safe in NMOSD treatment. More RCTs were expected to assess monoclonal antibodies in NMOSD.
视神经脊髓炎谱系疾病（NMOSD）是一种中枢神经系统（CNS）自身免疫性炎症性疾病，其特征为视神经、脊髓、脑干和大脑损伤的症状。最近的研究表明，单克隆抗体（利妥昔单抗、依库珠单抗、伊奈利珠单抗、satralizumab 等）对 NMOSD 的治疗有效。我们进行了一项荟萃分析，以评估这些单克隆抗体在 NMOSD 中的疗效和安全性。
检索 MEDLINE、EMBASE、CENTRAL 和 clinicaltrials.gov 数据库，评估单克隆抗体治疗 NMOSD 患者的随机对照试验（RCT）。
我们纳入了 4 项 RCTs 中的 524 例（单克隆抗体组 n=344，安慰剂组 n=180）和 444 例（84.7%）AQP4-IgG 阳性患者。单克隆抗体治疗降低了年复发率（均值 -0.27，95%CI -0.36 至 -0.18，P<0.0001）、试验期间复发风险（RR 0.25，95%CI 0.12 至 0.52，P=0.0003）、EDSS（扩展残疾状况量表）评分（均值 -0.51，95%CI -0.92 至 -0.11，P=0.01）和严重不良事件（RR 0.59，95%CI 0.37 至 0.96，P=0.03），但在总不良事件或死亡率方面无显著差异。亚组分析显示，与其他单克隆抗体相比，依库珠单抗在降低 AQP-4 阳性患者的试验期间复发风险方面可能更有效（Chi=9.84，P=0.002）。
单克隆抗体治疗 NMOSD 有效且安全。期待更多 RCT 评估 NMOSD 中单克隆抗体的疗效。
