Progressive multifocal leukoencephalopathy outcomes in patients with multiple sclerosis treated with dimethyl fumarate.

IF 2.5 Q2 CLINICAL NEUROLOGY Multiple Sclerosis Journal - Experimental, Translational and Clinical Pub Date : 2022-10-01 DOI:10.1177/20552173221132469

Jennifer Lyons, Richard Hughes, Kerry McCarthy, Nicholas Everage, Shivani Kapadia, Catherine Miller, Priya Singhal, Karen Smirnakis

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引用次数: 2

Abstract

Background and objectives: Dimethyl fumarate (DMF), an oral disease-modifying therapy with an established benefit and well-described safety profile, is among the most commonly used therapies for relapsing forms of multiple sclerosis. As of 31 December 2021, >560,000 patients have been treated with DMF, representing >1,190,000 person-years of exposure. Of these, 6413 patients (14,292 person-years) were from clinical trials.

Methods and results: Progressive multifocal leukoencephalopathy (PML) has occurred in the setting of lymphopenia (<0.91 × 10⁹/L) in patients treated with DMF. We present detailed clinical characteristics and outcomes of the 12 confirmed PML cases occurring in MS patients on DMF as of 21 July 2021. The PML incidence in DMF-treated patients is 1.07 per 100,000 person-years of DMF exposure. Lymphopenia is the common risk for PML in DMF treatment.

Discussion: DMF-related PML is rare but has occurred in the setting of lymphopenia, supporting the current recommendations for absolute lymphocyte count monitoring in all patients, regardless of age and time on therapy.

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富马酸二甲酯治疗多发性硬化症患者进行性多灶性白质脑病的预后

背景和目的:富马酸二甲酯(DMF)是一种口腔疾病改善疗法，具有确定的益处和良好的安全性，是复发型多发性硬化症最常用的治疗方法之一。截至2021年12月31日，>56万名患者接受了DMF治疗，暴露量> 119万人年。其中，6413例患者(14292人年)来自临床试验。方法和结果:进行性多灶性脑白质病(PML)发生在DMF治疗患者淋巴细胞减少(9/L)的情况下。我们介绍了截至2021年7月21日，在DMF治疗的MS患者中发生的12例确诊PML病例的详细临床特征和结果。DMF治疗患者的PML发病率为每100,000人-年DMF暴露1.07。淋巴细胞减少是DMF治疗中PML的常见风险。讨论:dmf相关的PML是罕见的，但在淋巴细胞减少的情况下也发生过，支持目前对所有患者进行绝对淋巴细胞计数监测的建议，无论年龄和治疗时间。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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