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奥瑞珠单抗:多发性硬化症的治疗药物。

Ocrelizumab: A Review in Multiple Sclerosis.

机构信息

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

出版信息

CNS Drugs. 2018 Sep;32(9):883-890. doi: 10.1007/s40263-018-0568-7.

Abstract

Ocrelizumab (Ocrevus) is a humanized anti-CD20 monoclonal antibody approved for the treatment of adults with relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS). In the two identically designed, 96-week OPERA I and II trials in patients with RMS, ocrelizumab significantly reduced annualized relapse rates versus interferon β-1a. In the ≥ 120-week ORATORIO trial in patients with PPMS, ocrelizumab significantly reduced the risk of ≥ 12-week confirmed disability progression relative to placebo. These primary endpoint results were supported by a number of secondary outcomes, including disease activity in the brain assessed by magnetic resonance imaging. Ocrelizumab was generally well tolerated in these studies, with infusion-related reactions and infections being the most common adverse events, which were mostly mild to moderate in severity. In summary, ocrelizumab is a novel high-efficacy disease-modifying therapy for RMS that is more effective than interferon β-1a and also a valuable new treatment option for delaying progression in early PPMS. It offers a convenient once every 6 months treatment regimen, with no need for routine monitoring.

摘要

奥瑞珠单抗(Ocrevus)是一种人源化抗 CD20 单克隆抗体,已被批准用于治疗成人复发型多发性硬化症(RMS)或原发性进展型多发性硬化症(PPMS)。在两项设计相同、为期 96 周的 RMS 患者 OPERA I 和 II 临床试验中,奥瑞珠单抗与干扰素 β-1a 相比显著降低了年化复发率。在为期≥120 周的 PPMS 患者 ORATORIO 试验中,奥瑞珠单抗与安慰剂相比显著降低了≥12 周确认残疾进展的风险。这些主要终点结果得到了许多次要终点的支持,包括通过磁共振成像评估的大脑疾病活动。在这些研究中,奥瑞珠单抗总体耐受性良好,输注相关反应和感染是最常见的不良事件,其严重程度大多为轻度至中度。总之,奥瑞珠单抗是一种治疗 RMS 的新型高效疾病修正疗法,比干扰素β-1a 更有效,也是早期 PPMS 延缓进展的一种有价值的新治疗选择。它提供了一种方便的每 6 个月治疗方案,无需常规监测。

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