Springer Nature, Mairangi Bay, Private Bag 65901, Auckland, 0754, New Zealand.
Drugs. 2022 Feb;82(3):323-334. doi: 10.1007/s40265-022-01672-9. Epub 2022 Feb 22.
Ocrelizumab (Ocrevus) is an intravenously administered, humanized anti-CD20 monoclonal antibody approved for the treatment of adults with relapsing forms of multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS). The efficacy of ocrelizumab in reducing relapse rates and disease activity in patients with RMS was demonstrated in pivotal trials (versus interferon β-1a) and supporting single-arm studies in specific subpopulations. In patients with PPMS, ocrelizumab reduced measures of clinical and MRI progression relative to placebo. Clinical benefits were maintained over ≥ 7.5 study years of treatment. Ocrelizumab was generally well tolerated and no new safety signals have emerged with long-term use. Extensive (albeit short-term) real-world data pertaining to ocrelizumab is consistent with that from clinical trials. Ocrelizumab provides the convenience of short, half-yearly infusions. Ocrelizumab continues to represent a generally well-tolerated, high-efficacy disease-modifying therapy (DMT) for RMS and is a valuable treatment for delaying disease progression in patients with PPMS (for whom there are currently no other approved DMTs).
奥瑞珠单抗(Ocrevus)是一种静脉注射用的人源化抗 CD20 单克隆抗体,已获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)。关键性试验(与干扰素β-1a 相比)和针对特定亚人群的支持性单臂研究均证实了奥瑞珠单抗在降低 RMS 患者的复发率和疾病活动度方面的疗效。在 PPMS 患者中,奥瑞珠单抗与安慰剂相比,降低了临床和 MRI 进展的衡量标准。在长达 7.5 年的治疗期间,临床获益得以维持。奥瑞珠单抗总体耐受性良好,长期使用未出现新的安全信号。与临床试验相比,奥瑞珠单抗的长期真实世界数据广泛存在(尽管时间较短)。奥瑞珠单抗提供了方便的半年输注。奥瑞珠单抗继续代表一种普遍耐受良好、高效的疾病修正治疗(DMT),是治疗 RMS 患者疾病进展的有效方法(目前针对 PPMS 患者尚无其他获得批准的 DMT)。