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依那西普单抗:视神经脊髓炎谱系疾病的研究进展。

Inebilizumab: A Review in Neuromyelitis Optica Spectrum Disorder.

机构信息

Springer Nature, Mairangi Bay, Private Bag 65901, Auckland, 0754, New Zealand.

出版信息

CNS Drugs. 2022 Oct;36(10):1133-1141. doi: 10.1007/s40263-022-00949-7. Epub 2022 Sep 7.

Abstract

Inebilizumab (Uplizna) is a recently approved monoclonal antibody for use in adults with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody seropositive. Inebilizumab targets the B cell antigen CD19 and effectively depletes circulating B cells, thus suppressing inflammatory NMOSD attacks that are potentially disabling or life-threatening. It is approved as an intravenous infusion in several countries. In the pivotal phase 2/3 N-MOmentum trial, inebilizumab reduced the risk of NMOSD attacks compared with placebo, including in AQP4-antibody seropositive patients. Inebilizumab also significantly reduced the risk of disability score worsening, the number of NMOSD-related hospitalisations and MRI lesion count, but had no significant effect on low-contrast binocular vision. The treatment effect on relapse risk and disability scores was sustained in inebilizumab-treated patients for ≥ 4 years during the open-label extension. Inebilizumab was generally well tolerated, with the most common adverse events being urinary tract infection and arthralgia. Thus, inebilizumab is an effective treatment option for adults with AQP4-antibody seropositive NMOSD.

摘要

依那西普单抗(Uplizna)是一种最近获批的单克隆抗体药物,适用于抗水通道蛋白 4(AQP4)抗体阳性的视神经脊髓炎谱系疾病(NMOSD)成人患者。依那西普单抗靶向 B 细胞抗原 CD19,能有效耗竭循环中的 B 细胞,从而抑制潜在致残或危及生命的炎症性 NMOSD 发作。该药已在多个国家获批静脉输注剂型。在关键性 2/3 期 N-MOmentum 试验中,与安慰剂相比,依那西普单抗降低了 NMOSD 发作风险,包括在 AQP4 抗体阳性患者中。依那西普单抗还显著降低了残疾评分恶化、NMOSD 相关住院和 MRI 病灶计数的风险,但对低对比双目视力无显著影响。在开放标签扩展研究中,依那西普单抗治疗患者的缓解风险和残疾评分治疗效果持续≥4 年。依那西普单抗总体耐受性良好,最常见的不良反应为尿路感染和关节痛。因此,依那西普单抗是 AQP4 抗体阳性 NMOSD 成人患者的有效治疗选择。

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