Awada Zeinab, Hameed Natasha, Harel Asaff
Northwell Comprehensive Multiple Sclerosis Center, Department of Neurology, Lenox Hill Hospital/Donald and Barbara Zucker School of Medicine at Hofstra, New York, NY, USA.
Northwell Comprehensive Multiple Sclerosis Center, Department of Neurology, Long Island Jewish Medical Center/ North Shore University Hospital/ Donald and Barbara Zucker School of Medicine at Hofstra, New York, NY, USA.
Drug Des Devel Ther. 2024 Dec 12;18:5985-5996. doi: 10.2147/DDDT.S315174. eCollection 2024.
Targeting B cells through monoclonal antibodies against CD20 has emerged as a highly effective strategy in managing disease activity in patients with relapsing forms of multiple sclerosis. This efficacy was initially demonstrated with rituximab and further affirmed with ocrelizumab. Ofatumumab is the first fully human IgG1 monoclonal antibody (mAb) approved for the treatment of MS. It is characterized by its convenient self-administered regimen of once-monthly subcutaneous injections. Its human antibody nature contributes to a significantly lower risk of immunogenicity compared to rituximab. Clinical trials have consistently shown its effectiveness in significantly reducing annualized relapse rates, MRI-detected lesion activity, and disability progression when compared to teriflunomide, a standard therapy for MS. Additionally, ofatumumab exhibits a manageable tolerability profile, with adverse events primarily comprising infections and injection-related reactions. This review describes ofatumumab pharmacology, core clinical trial data and clinical efficacy in addition to safety issues.
通过抗CD20单克隆抗体靶向B细胞已成为治疗复发型多发性硬化症患者疾病活动的一种高效策略。这种疗效最初在利妥昔单抗治疗中得到证实，并通过奥瑞珠单抗进一步得到确认。奥法妥木单抗是首个被批准用于治疗多发性硬化症的全人源IgG1单克隆抗体。其特点是采用方便的自我给药方案，每月皮下注射一次。与利妥昔单抗相比，其人源抗体性质导致免疫原性风险显著降低。临床试验一致表明，与多发性硬化症的标准疗法特立氟胺相比，它在显著降低年化复发率、磁共振成像检测到的病灶活动和残疾进展方面有效。此外，奥法妥木单抗具有可控的耐受性，不良事件主要包括感染和注射相关反应。本综述除了安全性问题外，还描述了奥法妥木单抗的药理学、核心临床试验数据和临床疗效。
