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从隔离治疗转为抗 CD20 耗竭治疗:奥瑞珠单抗治疗期间洗脱期和前 6 个月的疾病活动结果。

Switch from sequestering to anti-CD20 depleting treatment: disease activity outcomes during wash-out and in the first 6 months of ocrelizumab therapy.

机构信息

Multiple Sclerosis Center, Second Division of Neurology, Department of Advanced Medical and Surgical Sciences, University of Campania 'Luigi Vanvitelli', Naples, Italy.

Department of Neurosciences, Reproductive and Odontostomatological Sciences, Federico II University, Naples, Italy.

出版信息

Mult Scler. 2022 Jan;28(1):93-101. doi: 10.1177/13524585211005657. Epub 2021 Apr 15.

Abstract

OBJECTIVES

Switching between treatments is an opportunity for patients with multiple sclerosis (MS) to ameliorate disease control or safety. The aim of this study was to investigate the impact of switching from fingolimod (FTY) or natalizumab (NTZ) to ocrelizumab (OCR) on disease activity.

METHODS

We retrospectively enrolled 165 patients treated with OCR from 11 MS centres. We assessed the association of demographic and clinical characteristics on relapse rate (RR) and activity on magnetic resonance imaging (MRI) during wash-out and after 6 months of treatment with OCR through univariable and multivariable negative binomial regression models.

RESULTS

We registered a total of 35 relapses during the wash-out period. Previous treatment with FTY, relapses in the previous year, and relapsing-remitting course were associated with higher RR. In the first 6 months of OCR, 12 patients had clinical or MRI disease activity. Higher Expanded Disability Status Scale (EDSS) and higher lymphocyte count at OCR start were associated with a reduced probability of relapse.

DISCUSSION AND CONCLUSION

This study confirms that withdrawal from sequestering agents as FTY increases the risk of relapses in the wash-out period. Nevertheless, starting OCR before achieving complete immune reconstitution could limit its effectiveness in the first 6 months probably because trapped lymphocytes escape the CD20-mediated depletion.

摘要

目的

多发性硬化症(MS)患者在治疗方案转换时,有机会改善疾病控制或安全性。本研究旨在探讨从芬戈莫德(FTY)或那他珠单抗(NTZ)转换为奥瑞珠单抗(OCR)对疾病活动的影响。

方法

我们回顾性纳入了 11 个 MS 中心的 165 例接受 OCR 治疗的患者。我们通过单变量和多变量负二项回归模型评估了人口统计学和临床特征与冲洗期和 OCR 治疗 6 个月后的复发率(RR)和磁共振成像(MRI)活动之间的关联。

结果

冲洗期共记录了 35 次复发。先前接受 FTY 治疗、前一年复发和复发缓解型病程与更高的 RR 相关。在 OCR 的前 6 个月内,有 12 例患者出现临床或 MRI 疾病活动。较高的扩展残疾状况量表(EDSS)和 OCR 起始时较高的淋巴细胞计数与降低复发的可能性相关。

讨论与结论

本研究证实,在冲洗期停用隔离剂 FTY 会增加复发的风险。然而,在完全实现免疫重建之前开始使用 OCR 可能会限制其在前 6 个月的疗效,这可能是因为被捕获的淋巴细胞逃避了 CD20 介导的耗竭。

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