Neurocure Clinical Research Center, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, & Berlin Institute of Health, 10117 Berlin, Germany.
Experimental & Clinical Research Center, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, & Berlin Institute of Health & Max Delbrück Center for Molecular Medicine, 13125 Berlin, Germany.
Neurodegener Dis Manag. 2021 Feb;11(1):49-59. doi: 10.2217/nmt-2020-0046. Epub 2020 Nov 9.
Neuromyelitis optica spectrum disorder (NMOSD) is a rare and debilitating autoimmune astrocytopathy with a predominantly relapsing disease course. Satralizumab, a humanized monoclonal antibody, was designed to treat NMOSD by targeting the IL-6 receptor. Satralizumab builds on positive experiences of off-label use tocilizumab in recent years. Before 2019, no medications were approved for the treatment of NMOSD. In 2020, satralizumab became the third compound to enter the US market, adding to the complement inhibitor eculizumab and the CD19 inhibitor inebilizumab. Here, we review the two randomized, double-blind, Phase III trials that investigated the subcutaneous administration of satralizumab as add-on treatment and monotherapy. Both studies revealed positive effects concerning the reduction of relapse risk for AQP4 seropositive NMOSD patients and generally good tolerability.
视神经脊髓炎谱系疾病（NMOSD）是一种罕见且使人虚弱的自身免疫性星形胶质细胞病，主要表现为复发病程。Satralizumab 是一种人源化单克隆抗体，旨在通过靶向 IL-6 受体来治疗 NMOSD。Satralizumab 基于近年来tocilizumab 的经验。在 2019 年之前，没有药物被批准用于治疗 NMOSD。2020 年，satralizumab 成为第三种进入美国市场的化合物，补充了补体抑制剂 eculizumab 和 CD19 抑制剂 inebilizumab。在这里，我们回顾了两项随机、双盲、III 期临床试验，研究了 satralizumab 作为附加治疗和单药治疗的皮下给药。这两项研究都显示出对 AQP4 阳性 NMOSD 患者降低复发风险的积极影响，且总体耐受性良好。
