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在接受抗CD20单克隆抗体治疗的多发性硬化症患者中,未发现输液期间每日步数有波动迹象。

No evidence of fluctuations in daily step count between infusions in people with multiple sclerosis treated with anti-CD20 monoclonal antibodies.

作者信息

Block Valerie J, Henderson Kyra, Poole Shane, Joseph Gabby B, Gelfand Jeffrey M, Cree Bruce Ac, Bove Riley

机构信息

Department of Neurology, Weill Institute for Neurosciences, University of California San Francisco, San Francisco, CA, USA; Department of Physical Therapy and Rehabilitation Science, University of California, San Francisco, San Francisco, CA, USA.

Department of Neurology, Weill Institute for Neurosciences, University of California San Francisco, San Francisco, CA, USA.

出版信息

Mult Scler J Exp Transl Clin. 2025 Mar 25;11(1):20552173251329817. doi: 10.1177/20552173251329817. eCollection 2025 Jan-Mar.

DOI:10.1177/20552173251329817
PMID:40144903
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11938510/
Abstract

BACKGROUND

Patients with multiple sclerosis (MS) on some disease-modifying therapies (i.e., natalizumab), report a "wearing-off" effect characterized by increased symptoms directly before infusions. Prior research suggests this may reflect natural MS fluctuations rather than true treatment waning; however, this has not been confirmed for anti-CD20 agents (e.g., ocrelizumab). Daily step count (STEPS) can reflect overall function. This study examined temporal associations between anti-CD20 therapy infusions and STEPS.

METHODS

Retrospective analysis evaluated data from two Fitbit-monitored cohorts ( = 145 total, 32 anti-CD20-treated participants) across 60 treatment cycles. Monthly STEPS were recorded directly pre- and three-month post-infusion over the six-month treatment intervals. Mixed-effects models evaluated the relationship between infusion timing, STEPS, and participant demographics, controlling for confounding variables.

RESULTS

No significant difference in STEPS was observed pre- versus post-infusion ( = 0.32). An average decrease of 3.3% was noted post-infusion but was not statistically significant. No associations between STEPS and participant characteristics (e.g., age, disability level) were identified. Individual variability existed, but no clear group-level trends emerged.

CONCLUSIONS

This study found no evidence of an association between timing of anti-CD20 infusion and changes in STEPS. Findings highlight the need for integrating objective measures with patient-reported outcomes and biomarkers in future research to better understand potential treatment fluctuations.

摘要

背景

接受某些疾病修正疗法(即那他珠单抗)治疗的多发性硬化症(MS)患者报告有一种“药效消退”效应,其特征是在输液前症状加重。先前的研究表明,这可能反映的是MS的自然波动,而非真正的治疗效果减弱;然而,抗CD20药物(如奥瑞珠单抗)的这一情况尚未得到证实。每日步数(STEPS)可以反映整体功能。本研究调查了抗CD20治疗输液与STEPS之间的时间关联。

方法

回顾性分析评估了来自两个由Fitbit监测的队列(共145人,32名接受抗CD20治疗的参与者)在60个治疗周期的数据。在六个月的治疗间隔内,每月在输液前及输液后三个月直接记录STEPS。混合效应模型评估了输液时间、STEPS与参与者人口统计学特征之间的关系,并对混杂变量进行了控制。

结果

输液前和输液后STEPS无显著差异(P = 0.32)。输液后平均下降了3.3%,但无统计学意义。未发现STEPS与参与者特征(如年龄、残疾程度)之间存在关联。存在个体差异,但未出现明显的组水平趋势。

结论

本研究未发现抗CD20输液时间与STEPS变化之间存在关联的证据。研究结果强调,在未来的研究中需要将客观测量与患者报告的结果和生物标志物相结合,以更好地理解潜在的治疗波动。

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本文引用的文献

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The patient-reported wearing-off phenomenon with monoclonal antibody treatments for multiple sclerosis.患者报告的单克隆抗体治疗多发性硬化症时的疗效减退现象。
Mult Scler J Exp Transl Clin. 2024 May 6;10(2):20552173241251707. doi: 10.1177/20552173241251707. eCollection 2024 Apr-Jun.
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No Increase in Symptoms Toward the End of the Ocrelizumab Infusion Cycle in Patients With Multiple Sclerosis: Symptom Burden on Ocrelizumab: A Longitudinal Study (SymBOLS).多发性硬化症患者在奥瑞珠单抗输注周期结束时症状无增加:奥瑞珠单抗的症状负担:一项纵向研究(SymBOLS)
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The wearing-off phenomenon of ocrelizumab in patients with multiple sclerosis.奥瑞珠单抗治疗多发性硬化症患者的药效减退现象。
Mult Scler Relat Disord. 2022 Jan;57:103364. doi: 10.1016/j.msard.2021.103364. Epub 2021 Nov 1.
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Natalizumab wearing-off symptoms: Patients with MS on extended interval dosing may not "mind the gap".那他珠单抗药效减退症状:接受延长给药间隔治疗的多发性硬化症患者可能不会“在意间隔”。
Neurology. 2019 Oct 22;93(17):735-736. doi: 10.1212/WNL.0000000000008358. Epub 2019 Sep 24.
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Association of Continuous Assessment of Step Count by Remote Monitoring With Disability Progression Among Adults With Multiple Sclerosis.远程监测连续评估步数与多发性硬化症成人残疾进展的关联。
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