A Proposed Approach to Screening and Surveillance Labs for Patients With Multiple Sclerosis on Anti-CD20 Therapy.

IF 2.3 Q3 CLINICAL NEUROLOGY Neurology. Clinical practice Pub Date : 2024-02-01 Epub Date: 2024-01-04 DOI:10.1212/CPJ.0000000000200241
Stephanie Gandelman, Kerry A Lenzi, Clyde Markowitz, Joseph R Berger
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Abstract

Background: Anti-CD20 therapies have proven to be highly effective and safe therapies for multiple sclerosis (MS) and have had rapid uptake in the MS community. However, no clear consensus has arisen regarding an approach to screening or surveillance lab monitoring.

Recent findings: Based on current evidence, for screening labs before anti-CD20 initiation, we propose checking liver function test (LFT), complete blood count with differential (CBC), absolute B-cell count, quantitative immunoglobulins, hepatitis B virus serologies, varicella zoster virus IgG, John Cunningham virus (JCV) status, and age-appropriate vaccination history. For surveillance monitoring in an otherwise asymptomatic individual, we propose biannual LFTs and CBC, quantitative immunoglobulins annually after year 3, absolute B-cell count at month 6 and in the setting of relapse, and JCV only if clinical or radiographic features of progressive multifocal leukoencephalopathy arise. For ublituximab, pregnancy testing is additionally recommended before each infusion.

Implications for practice: We propose evidence-based screening and safety surveillance labs which take into account likelihood of changing management in an otherwise stable or asymptomatic individual.

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对接受抗 CD20 治疗的多发性硬化症患者进行筛查和监测实验室的拟议方法。
背景:抗 CD20 疗法已被证明是治疗多发性硬化症(MS)的高效、安全的疗法,并在多发性硬化症患者中迅速普及。然而,对于筛查或监测实验室的方法尚未达成明确共识:根据目前的证据,我们建议在开始使用抗 CD20 之前进行实验室筛查,检查肝功能检查 (LFT)、全血细胞计数(带差值)、B 细胞绝对计数、免疫球蛋白定量、乙型肝炎病毒血清学检查、水痘带状疱疹病毒 IgG、约翰-坎宁安病毒 (JCV) 状态以及与年龄相适应的疫苗接种史。对于无症状的患者,我们建议每半年进行一次低密度脂蛋白和全血细胞计数监测,第 3 年后每年进行一次免疫球蛋白定量监测,第 6 个月和复发时进行 B 细胞绝对计数监测,只有在出现进行性多灶性白质脑病的临床或影像学特征时才进行 JCV 监测。对于紫杉单抗,还建议在每次输注前进行妊娠检测:我们提出了以证据为基础的筛查和安全监测实验室,其中考虑到了原本病情稳定或无症状的患者改变治疗方案的可能性。
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来源期刊
Neurology. Clinical practice
Neurology. Clinical practice CLINICAL NEUROLOGY-
CiteScore
4.00
自引率
0.00%
发文量
77
期刊介绍: Neurology® Genetics is an online open access journal publishing peer-reviewed reports in the field of neurogenetics. The journal publishes original articles in all areas of neurogenetics including rare and common genetic variations, genotype-phenotype correlations, outlier phenotypes as a result of mutations in known disease genes, and genetic variations with a putative link to diseases. Articles include studies reporting on genetic disease risk, pharmacogenomics, and results of gene-based clinical trials (viral, ASO, etc.). Genetically engineered model systems are not a primary focus of Neurology® Genetics, but studies using model systems for treatment trials, including well-powered studies reporting negative results, are welcome.
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