Comparative Effectiveness of Fumarates Versus Sphingosine-1-Phosphate Receptor Modulators in Black Patients with Multiple Sclerosis.

IF 3.9 3区医学 Q1 CLINICAL NEUROLOGY

Neurology and Therapy Pub Date : 2025-06-16 DOI:10.1007/s40120-025-00774-2

Sophia Woodson, Edward J Gettings, Chu-Yueh Guo, Sylvia Klineova, Jong-Mi Lee, Rebecca S Romero, Aljoeson Walker, Nicholas Belviso, Sai L Shankar, Jason P Mendoza, Boyang Bian, James B Lewin, Kinyee Fong

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引用次数: 0

Abstract

Introduction: Multiple sclerosis (MS) is a heterogeneous disease that disproportionately impacts Black people with MS (PwMS), who experience more severe disease and higher relapse rates compared with non-Black populations. Despite widespread use of fumarates and sphingosine-1-phosphate (S1P) receptor modulators as oral disease-modifying therapies (DMTs) for relapsing MS, their comparative effectiveness in Black PwMS has not been studied. This study aims to help address this gap using real-world claims data.

Methods: This retrospective analysis using the Komodo Health Claims Database included Black PwMS. Patients were aged 18-64 years with ≥ 1 claim for MS diagnosis (International Classification of Diseases, Tenth Revision, Clinical Modification code G35) and ≥ 1 prescription claim for fumarates (dimethyl fumarate or diroximel fumarate) or an S1P receptor modulator (fingolimod, siponimod, ozanimod, or ponesimod) between January 2017 and April 2023. Outcomes included annualized relapse rate (ARR) and time to first relapse. Propensity score matching (2:1) and inverse probability weighting were used to balance baseline characteristics. Relapse events were identified using a claims-based algorithm.

Results: The analysis included 1664 Black PwMS (1231 and 433 in fumarate and S1P treatment arms, respectively). Post-index ARRs were comparable between groups (rate ratio [RR] 1.18, p = 0.423). Kaplan-Meier analyses showed similar relapse-free proportions at 24 months (72.6% and 74.7% in fumerate and S1P populations, respectively; p = 0.152). These findings were consistent in both the propensity score-matched and inverse probability weighted populations.

Conclusions: This real-world, claims-based analysis demonstrates that fumarates and S1P receptor modulators have similar effectiveness in reducing relapses among Black PwMS, with > 72% of patients in both treatment groups remaining relapse-free at 24 months. Given the underrepresentation of Black patients in MS clinical trials, these results provide valuable real-world evidence to guide treatment decisions for this population.

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富马酸盐与鞘氨醇-1-磷酸受体调节剂在黑人多发性硬化症患者中的比较疗效。

简介：多发性硬化症（MS）是一种异质疾病，黑人MS （PwMS）患者的影响尤为严重，与非黑人人群相比，他们的疾病更严重，复发率更高。尽管富马酸盐和鞘氨醇-1-磷酸（S1P）受体调节剂广泛用于复发性多发性硬化症的口腔疾病修饰疗法（DMTs），但它们在黑色PwMS中的相对有效性尚未研究。本研究旨在利用现实世界的索赔数据帮助解决这一差距。方法：使用Komodo健康声明数据库（包括Black PwMS）进行回顾性分析。患者年龄为18-64岁，在2017年1月至2023年4月期间，有≥1次MS诊断索赔（国际疾病分类，第十版，临床修改代码G35）和≥1次富马酸盐（富马酸二甲酯或富马酸地洛西梅尔）或S1P受体调节剂（fingolimod, siponimod， ozanimod或ponesimod）的处方索赔。结果包括年复发率（ARR）和首次复发时间。倾向评分匹配（2:1）和逆概率加权用于平衡基线特征。使用基于索赔的算法识别复发事件。结果：分析包括1664个黑色PwMS（富马酸组1231个，S1P组433个）。指数后arr组间具有可比性（RR = 1.18, p = 0.423）。Kaplan-Meier分析显示，在24个月时无复发的比例相似(在fumate和S1P人群中分别为72.6%和74.7%；p = 0.152)。这些发现在倾向得分匹配和逆概率加权人群中都是一致的。结论：这一现实世界的基于索赔的分析表明，富马酸盐和S1P受体调节剂在减少黑色PwMS复发方面具有相似的有效性，两组患者在24个月时均无复发。鉴于黑人患者在MS临床试验中的代表性不足，这些结果为指导该人群的治疗决策提供了有价值的现实证据。

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来源期刊

Neurology and Therapy CLINICAL NEUROLOGY-

CiteScore

5.40

自引率

8.10%

发文量

103

审稿时长

6 weeks

期刊介绍： Aims and Scope Neurology and Therapy aims to provide reliable and inclusive, rapid publication for all therapy related research for neurological indications, supporting the timely dissemination of research with a global reach, to help advance scientific discovery and support clinical practice. Neurology and Therapy is an international, open access, peer reviewed, rapid publication journal dedicated to the publication of high-quality clinical (all phases), observational, real-world and health outcomes research around the discovery, development, and use of neurological and psychiatric therapies, (also covering surgery and devices). Studies relating to diagnosis, pharmacoeconomics, public health, quality of life, and patient care, management, and education are also welcomed. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, case reports, trial designs, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Neurology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research. Rapid Publication The journal’s rapid publication timelines aim for a peer review decision within 2 weeks of submission. If an article is accepted, it will be published online 3-4 weeks from acceptance. These rapid timelines are achieved through the combination of a dedicated in-house editorial team, who closely manage article workflow, and an extensive Editorial and Advisory Board who assist with rapid peer review. This allows the journal to support the rapid dissemination of research, whilst still providing robust peer review. Combined with the journal’s open access model, this allows for the rapid and efficient communication of the latest research and reviews to support scientific discovery and clinical practice. Open Access All articles published by Neurology and Therapy are open access. Personal Service The journal’s dedicated in-house editorial team offer a personal “concierge service” meaning that authors will always have a personal point of contact able to update them on the status of their manuscript. The editorial team check all manuscripts to ensure that articles conform to the most recent COPE and ICMJE publishing guidelines. This supports the publication of ethically sound and transparent research. We also encourage pre-submission enquiries and are always happy to provide a confidential assessment of manuscripts. 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Peer Review Process Upon submission, manuscripts are assessed by the editorial team to ensure they fit within the aims and scope of the journal and are also checked for plagiarism. All suitable submissions are then subject to a comprehensive single-blind peer review. Reviewers are selected based on their relevant expertise and publication history in the subject area. The journal has an extensive pool of editorial and advisory board members who have been selected to assist with peer review based on the afore-mentioned criteria. At least two extensive reviews are required to make the editorial decision, with the exception of some article types such as Commentaries, Editorials and Letters which are generally reviewed by one member of the Editorial Board. Where reviews conflict, an Editorial Board Member will be contacted for further advice and a presiding decision. 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