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疾病修饰治疗对复发缓解型多发性硬化脊髓病变形成的疗效:MSBase 注册研究。

Effectiveness of Disease-Modifying Treatment on Spinal Cord Lesion Formation in Relapse-Onset Multiple Sclerosis: An MSBase Registry Study.

机构信息

Department of Neurology, Academic MS Center Zuyd, Zuyderland MC, Sittard-Geleen, The Netherlands.

School for Mental Health and Neuroscience, Department of Neurology, Maastricht University Medical Center, Maastricht, The Netherlands.

出版信息

CNS Drugs. 2024 Nov;38(11):921-930. doi: 10.1007/s40263-024-01115-x. Epub 2024 Sep 6.

Abstract

BACKGROUND

Spinal cord lesions in multiple sclerosis (MS) have considerable impact on disability. High-efficacy disease-modifying treatments (hDMTs) are associated with greater reduction of relapses and new brain lesions compared to low-efficacy treatments (lDMTs). Knowledge on the impact of DMTs on cord lesion formation is limited as these outcome measures were not included in MS treatment trials. This study aims to investigate whether hDMTs reduce the formation of cord lesions more effectively than lDMTs.

METHODS

Patients with relapse-onset MS, a cord magnetic resonance imaging (MRI) within 6 months before/after initiation of their first DMT and ≥1 cord MRI at follow-up (interval > 6 months) were extracted from the MSBase registry (ACTRN12605000455662). Patients treated with hDMTs ≥90% or lDMTs ≥90% of follow-up duration were considered the hDMT and lDMT groups, respectively. Matching was performed using propensity scores. Cox proportional hazards models were used to estimate the hazards of new cord lesions, brain lesions and relapses.

RESULTS

Ninety-four and 783 satisfied hDMT and lDMT group criteria, respectively. Seventy-seven hDMT patients were matched to 184 lDMT patients. In the hDMT group there was no evidence of reduction of new cord lesions (hazard ratio [HR] 0.99 [95% CI 0.51, 1.92], p = 0.97), while there were fewer new brain lesions (HR 0.22 [95% CI 0.10, 0.49], p < 0.001) and fewer relapses (HR 0.45 [95% CI 0.28, 0.72], p = 0.004).

CONCLUSION

A potential discrepancy exists in the effect of hDMTs over lDMTs in preventing spinal cord lesions versus brain lesions and relapses. While hDMTs provided a significant reduction for the latter when compared to lDMTs, there was no significant reduction in new spinal cord lesions.

摘要

背景

多发性硬化症(MS)中的脊髓损伤对残疾有重大影响。与低疗效疾病修正治疗(lDMT)相比,高效疾病修正治疗(hDMT)与更显著的复发和新的脑损伤减少相关。由于这些治疗结局并未包含在 MS 治疗试验中,因此关于 DMT 对脊髓损伤形成的影响的知识有限。本研究旨在探讨 hDMT 是否比 lDMT 更有效地减少脊髓损伤的形成。

方法

从 MSBase 登记处(ACTRN12605000455662)中提取了首次 DMT 治疗前/后 6 个月内有脊髓磁共振成像(MRI)且随访期间有≥1 次脊髓 MRI(间隔>6 个月)的复发型 MS 患者。将治疗中 hDMT 使用率≥90%或 lDMT 使用率≥90%的患者分别纳入 hDMT 和 lDMT 组。采用倾向评分进行匹配。使用 Cox 比例风险模型来估计新脊髓病变、新脑病变和复发的风险。

结果

分别有 94 名和 783 名患者符合 hDMT 和 lDMT 组标准。将 77 名 hDMT 患者与 184 名 lDMT 患者进行了匹配。在 hDMT 组,新脊髓病变没有减少的证据(风险比[HR]0.99 [95%CI 0.51, 1.92],p=0.97),但新脑病变(HR 0.22 [95%CI 0.10, 0.49],p<0.001)和复发(HR 0.45 [95%CI 0.28, 0.72],p=0.004)的发生率降低。

结论

在预防脊髓病变与脑病变和复发方面,hDMT 与 lDMT 的效果存在潜在差异。当与 lDMT 相比时,hDMT 显著降低了后两者的发生率,但新脊髓病变的发生率并没有显著降低。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0a72/11486785/5afc4a4e1724/40263_2024_1115_Fig1_HTML.jpg

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