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接受那他珠单抗治疗的黑人、西班牙裔、亚裔和白人多发性硬化症患者的真实世界治疗结果

Real-World Treatment Outcomes in Black, Hispanic, Asian, and White Patients with Multiple Sclerosis Treated with Natalizumab.

作者信息

Blitz-Shabbir Karen, Banks Aimee M, Garg Hina, Nelson Flavia, Shah Suma, Belviso Nicholas, Mendoza Jason P, Avila Robin L, Bian Boyang, Fong Kinyee

机构信息

New York Presbyterian Brooklyn Methodist MS Center, Brooklyn, NY, USA.

Multiple Sclerosis Center, Vanderbilt Specialty Pharmacy at Vanderbilt University Medical Center, Nashville, TN, USA.

出版信息

Drugs Real World Outcomes. 2025 May 30. doi: 10.1007/s40801-025-00495-w.

Abstract

BACKGROUND

Multiple sclerosis (MS) is a heterogeneous disease that may manifest differently among racial/ethnic groups, influencing response to disease-modifying therapy (DMT). Data on natalizumab (NTZ) effectiveness in people with MS (PwMS) based on race/ethnicity are limited.

OBJECTIVE

The aim of this study was to evaluate the effectiveness of NTZ on relapse onset and rate, and to assess MS-related healthcare encounters and costs in Black, Hispanic, Asian, and White PwMS.

METHODS

This was a retrospective analysis of the Komodo Health Claims Database, including adult patients in the US with one or more MS claim at index date (January 1, 2016-August 31, 2022). Patients were followed from first NTZ exposure through end of study, end of insurance eligibility, gap in index DMT > 45 days, or DMT switch. Annualized relapse rate (ARR), time to first relapse, and MS-related healthcare encounters and costs were compared in the 12 months pre/post NTZ initiation and while on treatment across racial strata.

RESULTS

The study included 3244 PwMS (Black, n = 632; Hispanic, n = 382; Asian, n = 49; White, n = 2181). Mean post-index NTZ exposure was 15.5-19.2 months. Post-index ARRs were significantly reduced across racial/ethnic groups (p < 0.001). The adjusted Kaplan-Meier estimated proportion of relapse-free patients at 2 years for all racial/ethnic groups was not significantly different from the White group. Significant differences were observed in annualized MS-related healthcare cost rates but not in annualized MS-related encounter rates before and after NTZ initiation across the racial/ethnic groups.

CONCLUSION

NTZ was effective across racial/ethnic groups although not significantly different between groups.

摘要

背景

多发性硬化症(MS)是一种异质性疾病,在不同种族/族裔群体中可能有不同表现,影响对疾病修饰治疗(DMT)的反应。基于种族/族裔的那他珠单抗(NTZ)对多发性硬化症患者(PwMS)有效性的数据有限。

目的

本研究的目的是评估NTZ对复发起始和复发率的有效性,并评估黑人、西班牙裔、亚裔和白人PwMS中与MS相关的医疗接触和费用。

方法

这是对科莫多健康索赔数据库的回顾性分析,包括在索引日期(2016年1月1日至2022年8月31日)有一项或多项MS索赔的美国成年患者。患者从首次接触NTZ开始随访至研究结束、保险资格结束、索引DMT间隔>45天或DMT转换。比较了NTZ开始前/后12个月以及治疗期间不同种族分层的年化复发率(ARR)、首次复发时间以及与MS相关的医疗接触和费用。

结果

该研究纳入了3244例PwMS(黑人,n = 人口数;西班牙裔,n = 382;亚裔,n = 49;白人,n = 2181)。索引后NTZ的平均暴露时间为15.5 - 19.2个月。各种族/族裔群体的索引后ARR均显著降低(p < 0.001)。所有种族/族裔群体在2年时无复发患者的调整后Kaplan-Meier估计比例与白人组无显著差异。不同种族/族裔群体在NTZ开始前后的年化MS相关医疗费用率存在显著差异,但年化MS相关就诊率无显著差异。

结论

NTZ在不同种族/族裔群体中均有效,尽管各群体之间无显著差异。

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