Ofatumumab治疗多发性硬化症的概况:设计、开发和治疗中的地位。

IF 4.7 2区 医学 Q1 CHEMISTRY, MEDICINAL Drug Design, Development and Therapy Pub Date : 2024-12-12 eCollection Date: 2024-01-01 DOI:10.2147/DDDT.S315174
Zeinab Awada, Natasha Hameed, Asaff Harel
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引用次数: 0

摘要

通过针对CD20的单克隆抗体靶向B细胞已成为控制复发型多发性硬化症患者疾病活动的一种非常有效的策略。这种疗效最初是用利妥昔单抗证明的,并用奥克雷单抗进一步证实。Ofatumumab是首个被批准用于治疗多发性硬化症的全人IgG1单克隆抗体(mAb),其特点是其方便的自我给药方案,每月一次皮下注射。与利妥昔单抗相比,其人抗体性质显著降低了免疫原性风险。临床试验一致表明,与特利氟米特(ms的标准治疗方法)相比,ofatumumab在显著降低年化复发率、mri检测到的病变活动性和残疾进展方面的有效性。此外,ofatumumab表现出可控的耐受性,不良事件主要包括感染和注射相关反应。本综述描述了ofatumumab的药理学、核心临床试验数据和临床疗效以及安全性问题。
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Profile of Ofatumumab in the Treatment of Multiple Sclerosis: Design, Development and Place in Therapy.

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.

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来源期刊
Drug Design, Development and Therapy
Drug Design, Development and Therapy CHEMISTRY, MEDICINAL-PHARMACOLOGY & PHARMACY
CiteScore
9.00
自引率
0.00%
发文量
382
审稿时长
>12 weeks
期刊介绍: Drug Design, Development and Therapy is an international, peer-reviewed, open access journal that spans the spectrum of drug design, discovery and development through to clinical applications. The journal is characterized by the rapid reporting of high-quality original research, reviews, expert opinions, commentary and clinical studies in all therapeutic areas. Specific topics covered by the journal include: Drug target identification and validation Phenotypic screening and target deconvolution Biochemical analyses of drug targets and their pathways New methods or relevant applications in molecular/drug design and computer-aided drug discovery* Design, synthesis, and biological evaluation of novel biologically active compounds (including diagnostics or chemical probes) Structural or molecular biological studies elucidating molecular recognition processes Fragment-based drug discovery Pharmaceutical/red biotechnology Isolation, structural characterization, (bio)synthesis, bioengineering and pharmacological evaluation of natural products** Distribution, pharmacokinetics and metabolic transformations of drugs or biologically active compounds in drug development Drug delivery and formulation (design and characterization of dosage forms, release mechanisms and in vivo testing) Preclinical development studies Translational animal models Mechanisms of action and signalling pathways Toxicology Gene therapy, cell therapy and immunotherapy Personalized medicine and pharmacogenomics Clinical drug evaluation Patient safety and sustained use of medicines.
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