Ofatumumab治疗复发缓解型多发性硬化症的Meta分析

Medicine Advances Pub Date : 2023-09-14 DOI:10.1002/med4.33

Peter Olujimi Odutola, Peter Oluwatobi Olorunyomi, Olanrewaju Olamide Olatawura, Ifeoluwapo Olorunyomi, Olukayode Oluyinka Madojutimi, Uju Okeke, Ayomide O. Fatunsin, Victoria Eneh

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引用次数: 0

摘要

背景Ofatumumab是第一种专门用于治疗复发性多发性硬化症（RMS）的单克隆抗体。这种疾病（多发性硬化症）包括复发-缓解型多发性痴呆症（RRMS），这是一种影响中枢神经系统（CNS）（包括大脑和脊髓）的慢性自身免疫性疾病。本研究的目的是确定Ofatumumab在治疗复发-缓解型多发性硬化症方面是否有效和安全。方法根据PRISMA指南，对复发缓解型多发性硬化症患者奥法图单抗与安慰剂的比较研究进行分析。我们查阅了MEDLINE、SciSearch、BIOSIS Previews、Derwent Drug File、Embase和International Pharmaceutical Abstracts中的信息。在复发-缓解型多发性硬化症患者中，两名独立研究人员发现了Ofatumumab与安慰剂的随机双盲和非随机对照试验。利用Review Manager 5.4.1对数据进行检查。主要结果是总钆增强（Gd+）T1病变、年化复发率和新的或扩大的总T2病变。次要结果集中在一般不良事件和与感染相关的不良事件上。结果纳入了3项涉及334名患者的研究，荟萃分析表明，奥法图单抗在复发型多发性硬化症患者中显示出良好的疗效和安全性。Ofatumumab显著降低了年复发率（OR 0.51；95%CI 0.27，0.98；P=0.04）。Ofatumuab减少了每次扫描的钆增强（Gd+）T1病变的数量（平均差异−0.59；95%CI−0.63，−0.55；P<；0.05）。Oftumumab治疗显著减少了新的或扩大的总T2病变（平均差异–1.03；95%CI–1.29，−0.76；P<）与感染相关的不良反应在奥法图单抗中更常见，奇数比为0.48；95%置信区间0.221.04；P=0.06。因此，感染是其使用的主要限制。结论荟萃分析表明奥法图单抗对复发型多发性硬化症患者是有效和安全的。

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Meta-analysis of the use of Ofatumumab in the treatment of relapsing-remitting multiple sclerosis

Background

Ofatumumab is the first monoclonal antibody developed specifically for treating relapsed multiple sclerosis (RMS). This disease (Multiple Sclerosis) includes relapsing–remitting multiple sclerosis (RRMS), a chronic autoimmune illness that affects the central nervous system (CNS), including the brain and spinal cord. The purpose of this study is to determine whether Ofatumumab is efficacious and safe in the treatment of relapsing–remitting multiple sclerosis.

Methods

An analysis of studies comparing Ofatumumab with placebo in people with relapsing-remitting multiple sclerosis was done in accordance with PRISMA guidelines. We looked up information in MEDLINE, SciSearch, BIOSIS Previews, Derwent Drug File, Embase, and International Pharmaceutical Abstracts. In patients with relapsing–remitting multiple sclerosis, randomized double-blind and non-randomized trials contrasting Ofatumumab with placebo were found by two independent investigators. Utilizing Review Manager 5.4.1, data were examined. The main results were total gadolinium-enhancing (Gd+) T1 lesions, annualized relapse rate, and new or expanding total T2 lesions. Secondary outcomes concentrated on general adverse events and adverse events related to infections.

Results

Three studies were included involving 334 patients, and the meta-analysis indicated that Ofatumumab showed good efficacy and safety in patients with relapsing forms of multiple sclerosis. The annual rate of relapse was significantly reduced by Ofatumumab (OR 0.51; 95% CI 0.27, 0.98; P = 0.04). Ofatumumab reduced the number of gadolinium-enhancing (Gd+) T1 lesions per scan (Mean difference −0.59; 95% CI −0.63, −0.55; P < 0.05). Ofatumumab treatment decreased new or enlarging total T2 lesions significantly (Mean difference −1.03; 95% CI −1.29, −0.76; P < 0.05). Infection-related adverse effects were seen more frequently with Ofatumumab shown by the odd ratio 0.48; 95% CI 0.22, 1.04; P = 0.06. Infection is, thus, a major limitation to its use.

Conclusion

The meta-analysis indicated that Ofatumumab is efficacious and safe for patients with relapsing forms of multiple sclerosis.

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