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进行 PML 风险分层后停用那他珠单抗:共同决策和知情决策的结果。

Natalizumab discontinuation after PML risk stratification: outcome from a shared and informed decision.

机构信息

Clinical Neuroimmunology Unit, Multiple Sclerosis Centre of Catalonia (Centre d'Esclerosi Múltiple de Catalunya, CEM-Cat), Vall d'Hebron University Hospital, Barcelona, Spain.

出版信息

Mult Scler. 2012 Aug;18(8):1193-6. doi: 10.1177/1352458512439238. Epub 2012 Mar 1.

DOI:10.1177/1352458512439238
PMID:22383232
Abstract

Multifocal progressive leukoencephalopathy (PML) is associated with JC virus (JCV) seropositivity, past immunosuppression, and natalizumab treatment for two years or more. The aim of our study was to investigate the rate of treatment discontinuation after stratifying for the three risk factors in a group of 104 natalizumab-treated patients with relapsing-remitting multiple sclerosis. We investigated JCV serological status in our population. We then divided patients into groups according to their PML risk. Treatment indication was reassessed. Of the patients, 64 (61.5%) were JCV seropositive. Amongst seropositive patients on natalizumab for 2 years or more, 10 had received immunosuppression (group A), and 38 had not (group B). After an informed and shared decision-making process, 6/10 (60%) from group A compared with 9/38 (23.7%) from group B discontinued treatment (p=0.027). In groups A and B, discontinuation also depended upon doctors' views (p=0.019, group A; p=0.010, group B) and clinical outcomes (p=0.021, group A). No-one from low-intermediate risk groups discontinued. The decision to discontinue natalizumab treatment is complex, even when clear PML risk rates are described. Clinical outcomes and doctors' idiosyncrasies play a crucial part in patients' final choice.

摘要

多灶进行性脑白质病(PML)与 JC 病毒(JCV)血清阳性、既往免疫抑制和纳武单抗治疗两年或更长时间有关。我们的研究目的是在 104 名接受纳武单抗治疗的复发性缓解型多发性硬化症患者中,根据这三个危险因素进行分层,调查治疗中断的发生率。我们调查了我们人群中的 JCV 血清学状态。然后,我们根据患者的 PML 风险将其分为几组。重新评估治疗指征。在这些患者中,64 名(61.5%)为 JCV 血清阳性。在 JCV 血清阳性且接受纳武单抗治疗 2 年或以上的患者中,有 10 名接受了免疫抑制治疗(A 组),38 名未接受免疫抑制治疗(B 组)。经过知情和共同决策过程,A 组的 6/10(60%)与 B 组的 9/38(23.7%)相比停止了治疗(p=0.027)。在 A 组和 B 组中,停药也取决于医生的意见(p=0.019,A 组;p=0.010,B 组)和临床结果(p=0.021,A 组)。低-中危组中没有人停药。即使明确了 PML 风险率,停止纳武单抗治疗的决定也很复杂。临床结果和医生的个性特点在患者的最终选择中起着至关重要的作用。

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Mult Scler. 2012 Aug;18(8):1193-6. doi: 10.1177/1352458512439238. Epub 2012 Mar 1.
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引用本文的文献

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PML risk is the main factor driving the choice of discontinuing natalizumab in a large multiple sclerosis population: results from an Italian multicenter retrospective study.PML 风险是导致大型多发性硬化症患者停用那他珠单抗的主要因素:来自意大利多中心回顾性研究的结果。
J Neurol. 2022 Feb;269(2):933-944. doi: 10.1007/s00415-021-10676-6. Epub 2021 Jun 28.
2
Is the risk of progressive multifocal leukoencephalopathy the real reason for natalizumab discontinuation in patients with multiple sclerosis?进行性多灶性白质脑病的风险是多发性硬化症患者停用那他珠单抗的真正原因吗?
PLoS One. 2017 Apr 13;12(4):e0174858. doi: 10.1371/journal.pone.0174858. eCollection 2017.
3
Risk acceptance in multiple sclerosis patients on natalizumab treatment.
接受那他珠单抗治疗的多发性硬化症患者的风险接受情况。
PLoS One. 2013 Dec 10;8(12):e82796. doi: 10.1371/journal.pone.0082796. eCollection 2013.
4
Risk-benefit considerations in the treatment of relapsing-remitting multiple sclerosis.治疗复发缓解型多发性硬化的风险效益考量。
Neuropsychiatr Dis Treat. 2013;9:893-914. doi: 10.2147/NDT.S45144. Epub 2013 Jun 24.
5
Best practice in the use of natalizumab in multiple sclerosis.多发性硬化症中那他珠单抗的最佳使用实践。
Ther Adv Neurol Disord. 2013 Mar;6(2):69-79. doi: 10.1177/1756285612470401.