Woodson Sophia, Gettings Edward J, Guo Chu-Yueh, Klineova Sylvia, Lee Jong-Mi, Romero Rebecca S, Walker Aljoeson, Belviso Nicholas, Shankar Sai L, Mendoza Jason P, Bian Boyang, Lewin James B, Fong Kinyee
University Hospitals, Cleveland, OH, USA.
Temple Health, Philadelphia, PA, USA.
Neurol Ther. 2025 Jun 16. doi: 10.1007/s40120-025-00774-2.
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.
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.
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.
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.
多发性硬化症（MS）是一种异质性疾病，对患有MS的黑人（黑人MS患者）影响尤为严重，与非黑人人群相比，他们经历更严重的疾病和更高的复发率。尽管富马酸盐和鞘氨醇-1-磷酸（S1P）受体调节剂作为复发型MS的口服疾病修正疗法（DMTs）被广泛使用，但它们在黑人MS患者中的相对有效性尚未得到研究。本研究旨在利用真实世界的索赔数据来填补这一空白。
这项使用科莫多健康索赔数据库的回顾性分析纳入了黑人MS患者。患者年龄在18至64岁之间，有≥1次MS诊断索赔（国际疾病分类第十版临床修订版代码G35），并且在2017年1月至2023年4月期间有≥1次富马酸盐（富马酸二甲酯或二罗昔麦尔富马酸盐）或S1P受体调节剂（芬戈莫德、西普尼莫德、奥扎尼莫德或波尼莫德）的处方索赔。结局指标包括年化复发率（ARR）和首次复发时间。使用倾向得分匹配（2:1）和逆概率加权来平衡基线特征。使用基于索赔的算法识别复发事件。
分析纳入了1664名黑人MS患者（富马酸盐治疗组和S1P治疗组分别为1231名和433名）。两组的索引后ARR相当（率比[RR]为1.18，p = 0.423）。Kaplan-Meier分析显示，在24个月时无复发比例相似（富马酸盐组和S1P组分别为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均一致。
这项基于真实世界索赔数据的分析表明，富马酸盐和S1P受体调节剂在减少黑人MS患者复发方面具有相似的有效性，两个治疗组中超过72%的患者在24个月时保持无复发。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真实世界证据。
