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到目前为止,我们对奥法木单抗治疗复发性多发性硬化症了解多少?一项荟萃分析研究。

What Do We Know So Far about Ofatumumab for Relapsing Multiple Sclerosis? A Meta-Analytical Study.

作者信息

Taj Hafiza Munazza, Talib Maryam, Siddiqa Sania, Sarfraz Azza, Sarfraz Zouina, Robles-Velasco Karla, Cherrez-Ojeda Ivan

机构信息

Research and Publications, Fatima Jinnah Medical University, Lahore 54000, Pakistan.

Research, Services Institute of Medical Sciences, Lahore 54000, Pakistan.

出版信息

Healthcare (Basel). 2022 Nov 2;10(11):2199. doi: 10.3390/healthcare10112199.

DOI:10.3390/healthcare10112199
PMID:36360540
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9690388/
Abstract

Ofatumumab is a monoclonal antibody that reduces the level of B cells that alter the progression of relapsing multiple sclerosis. Originally approved by the Food and Drug Administration (FDA) in August 2020, this meta-analysis determines the outcomes of four randomized controlled trials (RCTs) for endline outcomes of Gadolinium-enhancing T1 lesions on MRI scans reported as Cohen’s d and relapse rate reported as risk ratio. All four RCTs reported favorable findings of gadolinium-enhancing T1 lesions (Cohen’s d = −0.44, p < 0.00001). The relapse rate was reduced by 46% post ofatumumab administration (RR = 0.54, p < 0.00001). With 14 ongoing trials in this area, more data is required to consolidate our findings.

摘要

奥法妥木单抗是一种单克隆抗体,可降低改变复发型多发性硬化症病程的B细胞水平。该药物最初于2020年8月获得美国食品药品监督管理局(FDA)批准,本荟萃分析确定了四项随机对照试验(RCT)的结果,这些试验的终末结局为MRI扫描上钆增强T1病变,以科恩d值报告,复发率以风险比报告。所有四项RCT均报告了钆增强T1病变的有利结果(科恩d值 = -0.44,p < 0.00001)。奥法妥木单抗给药后复发率降低了46%(风险比 = 0.54,p < 0.00001)。该领域有14项正在进行的试验,需要更多数据来巩固我们的研究结果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7ffa/9690388/ea101300ea99/healthcare-10-02199-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7ffa/9690388/1be7547dd62f/healthcare-10-02199-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7ffa/9690388/279c88d22c99/healthcare-10-02199-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7ffa/9690388/ea101300ea99/healthcare-10-02199-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7ffa/9690388/1be7547dd62f/healthcare-10-02199-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7ffa/9690388/279c88d22c99/healthcare-10-02199-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7ffa/9690388/ea101300ea99/healthcare-10-02199-g003.jpg

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本文引用的文献

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Mult Scler Relat Disord. 2022 Oct;66:104031. doi: 10.1016/j.msard.2022.104031. Epub 2022 Jul 4.
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Population Pharmacokinetic-B Cell Modeling for Ofatumumab in Patients with Relapsing Multiple Sclerosis.群体药代动力学-B 细胞模型分析奥法妥木单抗在复发型多发性硬化症患者中的应用。
CNS Drugs. 2022 Mar;36(3):283-300. doi: 10.1007/s40263-021-00895-w. Epub 2022 Mar 1.
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Ofatumumab: A Review in Relapsing Forms of Multiple Sclerosis.
奥法妥木单抗:治疗多发性硬化症复发型的研究进展。
Drugs. 2022 Jan;82(1):55-62. doi: 10.1007/s40265-021-01650-7.
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Mult Scler. 2022 Jul;28(8):1229-1238. doi: 10.1177/13524585211055934. Epub 2021 Nov 17.
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The PRISMA 2020 statement: An updated guideline for reporting systematic reviews.PRISMA 2020 声明:系统评价报告的更新指南。
PLoS Med. 2021 Mar 29;18(3):e1003583. doi: 10.1371/journal.pmed.1003583. eCollection 2021 Mar.
6
Anti-CD20 B Cell Treatment for Relapsing Multiple Sclerosis.抗CD20 B细胞疗法治疗复发型多发性硬化症。
Front Neurol. 2021 Jan 22;11:595547. doi: 10.3389/fneur.2020.595547. eCollection 2020.
7
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8
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