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真实世界中奥瑞珠单抗治疗多发性硬化症的评价:系统评价。

Real-world evaluation of ocrelizumab in multiple sclerosis: A systematic review.

机构信息

Department of Neurology, Centre d'Esclerosi Mútiple de Catalunya (Cemcat), Barcelona, Spain.

Department of Brain Sciences, UK Dementia Research Institute Centre at Imperial College London, London, UK.

出版信息

Ann Clin Transl Neurol. 2023 Mar;10(3):302-311. doi: 10.1002/acn3.51732. Epub 2023 Feb 2.

Abstract

Across its clinical development program, ocrelizumab demonstrated efficacy in improving clinical outcomes in multiple sclerosis, including annualized relapse rates and confirmed disability progression. However, as with any new treatment, it was unclear how this efficacy would translate into real-world clinical practice. The objective of this study was to systematically collate the published real-world clinical effectiveness data for ocrelizumab in relapsing remitting multiple sclerosis and primary progressive multiple sclerosis. A search strategy was developed in MEDLINE and Embase to identify articles reporting real-world evidence in people with relapsing remitting multiple sclerosis or primary progressive multiple sclerosis receiving treatment with ocrelizumab. The search focused on English language articles only but was not limited by the country in which the study was conducted or the time frame of the study. Additional manual searches of relevant websites were also performed. Fifty-two studies were identified reporting relevant evidence. Real-world effectiveness data for ocrelizumab were consistently favorable, with reductions in relapse rate and disease progression rates similar to those reported in the OPERA I/OPERA II and ORATORIO clinical trials, including in studies with more diverse patient populations not well represented in the pivotal trials. Although direct comparisons are confounded by lack of randomization of treatments, outcomes reported suggest that ocrelizumab has a similar or greater efficacy than other therapy options. Initial real-world effectiveness data for ocrelizumab appear favorable and consistent with results reported in clinical trials, providing clinicians with an efficacious option to treat patients with multiple sclerosis.

摘要

在其临床开发项目中,奥瑞珠单抗在多发性硬化症中显示出改善临床结果的疗效,包括年度复发率和确认的残疾进展。然而,与任何新的治疗方法一样,尚不清楚这种疗效将如何转化为实际的临床实践。本研究的目的是系统地整理奥瑞珠单抗在复发缓解型多发性硬化症和原发性进行性多发性硬化症中的已发表的真实世界临床疗效数据。制定了 MEDLINE 和 Embase 的搜索策略,以确定报告奥瑞珠单抗治疗复发缓解型多发性硬化症或原发性进行性多发性硬化症患者真实世界证据的文章。搜索仅侧重于英语文章,但不受研究开展的国家或研究时间框架的限制。还对相关网站进行了额外的手动搜索。确定了 52 项报告相关证据的研究。奥瑞珠单抗的真实世界疗效数据始终是有利的,复发率和疾病进展率的降低与 OPERA I/OPERA II 和 ORATORIO 临床试验报告的结果相似,包括在关键试验中代表性不足的患者人群更为多样化的研究中。尽管由于缺乏治疗的随机化,直接比较受到干扰,但报告的结果表明,奥瑞珠单抗的疗效与其他治疗选择相似或更优。奥瑞珠单抗的初步真实世界疗效数据似乎是有利的,与临床试验报告的结果一致,为临床医生提供了一种有效的治疗多发性硬化症患者的选择。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2e6f/10014013/bd8f4dab3530/ACN3-10-302-g002.jpg

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