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Drugs. 2017 Mar;77(4):447-458. doi: 10.1007/s40265-017-0708-2.
Daclizumab (Zinbryta; previously known as daclizumab high-yield process) is a therapeutic monoclonal antibody that has recently been approved for the treatment of relapsing forms of multiple sclerosis (MS) in adults. Daclizumab is a humanized IgG1 monoclonal antibody directed against CD25, the alpha subunit of the high-affinity interleukin-2 receptor. As demonstrated in the phase III DECIDE trial, once-monthly subcutaneous daclizumab was superior to once-weekly intramuscular interferon (IFN) β-1a in reducing the clinical relapse rate and radiological measures of disease in patients with relapsing-remitting MS. In addition, daclizumab has demonstrated efficacy in reducing disability progression and in improving health-related quality of life in patients with relapsing MS. Ongoing open-label clinical trials indicate that daclizumab's efficacy is maintained in the longer term (3 years or more). Daclizumab appears to be generally well tolerated, with adverse events of interest (including hepatic, infectious and cutaneous events) generally manageable with regular monitoring and/or standard therapies. The place of daclizumab in MS treatment remains to be fully determined. However, based on available evidence, daclizumab provides a useful alternative option to other currently available disease-modifying therapies in the treatment of relapsing MS.
达利珠单抗（商品名：Zinbryta；曾用名：达利珠单抗高产量工艺）是一种治疗性单克隆抗体，最近被批准用于治疗成人复发性多发性硬化症（MS）。达利珠单抗是一种针对 CD25 的人源化 IgG1 单克隆抗体，CD25 是高亲和力白细胞介素-2 受体的 α 亚基。在 III 期 DECIDE 试验中，每月一次皮下注射达利珠单抗在降低复发缓解型多发性硬化症患者的临床复发率和疾病影像学指标方面优于每周一次肌肉内注射干扰素（IFN）β-1a。此外，达利珠单抗在降低复发型 MS 患者的残疾进展率和改善健康相关生活质量方面显示出疗效。正在进行的开放标签临床试验表明，达利珠单抗的疗效在较长时间内（3 年或更长时间）得以维持。达利珠单抗总体耐受性良好，与肝、感染和皮肤相关的不良事件（AE）通常可以通过定期监测和/或标准治疗来管理。达利珠单抗在 MS 治疗中的地位仍有待充分确定。然而，基于现有证据，达利珠单抗为其他目前可用的疾病修正疗法在治疗复发性 MS 方面提供了一种有用的替代选择。
