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《那他珠单抗治疗复发性多发性硬化症患者的实用临床指南》。

Practical Clinical Guidelines for Natalizumab Treatment in Patients With Relapsing Multiple Sclerosis.

机构信息

Dallas VA Medical Center MS Center, Dallas, Texas (Ms O'Leary); Long Ridge Medical Center, Neurology, Greenwich Hospital, Stamford, Connecticut (Ms Brugger); Rocky Mountain MS Clinic, Salt Lake City, Utah (Mr Wallentine); The Regional MS Center & The Center for Neurological Disorders, Milwaukee, Wisconsin (Ms Sershon); University of Alabama at Birmingham, Birmingham, Alabama (Ms Goff); Biogen, Cambridge, Massachusetts (Mss Saldana-King and Beavin; Drs Avila and Rutledge); Novant MS Care Center, Charlotte, North Carolina (Ms Moore).

Shirley O'Leary, MS, APN-C, MSCN, has practiced as a provider, subinvestigator/researcher, and neurology infusion manager for 7 years at the MS Center of Excellence at the Dallas VA Medical Center. She has 27 years of experience in the area of multiple sclerosis (MS) and has authored articles, given numerous invited talks, and is a longstanding member of the International Organization of MS Nurses.

出版信息

J Infus Nurs. 2023;46(6):347-359. doi: 10.1097/NAN.0000000000000519.

DOI:10.1097/NAN.0000000000000519
PMID:37920108
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10635346/
Abstract

Natalizumab (TYSABRI®) was the first high-efficacy monoclonal antibody disease-modifying therapy (DMT) approved as a monotherapy for the treatment of adults with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS. Because natalizumab is administered by intravenous infusion, infusion nurses play a key role in the care of natalizumab-treated patients. In the 16 years since approval, substantial data have been gathered on the long-term, real-world effectiveness and safety of natalizumab. This article provides a synopsis of this data, as well as practical information for optimizing patient care. This includes information on strategies to mitigate the risk of progressive multifocal leukoencephalopathy in natalizumab-treated patients, natalizumab use during pregnancy, and use with vaccines. It also includes guidance on the preparation and administration of natalizumab and monitoring of natalizumab-treated patients.

摘要

那他珠单抗(TYSABRI®)是首个被批准用于治疗成人复发型多发性硬化症(MS)的高效单克隆抗体疾病修正治疗药物(DMT),包括临床孤立综合征、复发缓解型 MS 和活动性继发进展型 MS。由于那他珠单抗是通过静脉输注给药的,输注护士在那他珠单抗治疗患者的护理中起着关键作用。自批准以来的 16 年中,已经收集了大量关于那他珠单抗的长期、真实世界的有效性和安全性数据。本文对这些数据进行了总结,并提供了优化患者护理的实用信息。这包括了降低那他珠单抗治疗患者进行性多灶性白质脑病风险的策略、那他珠单抗在怀孕期间的使用以及与疫苗联合使用的信息。它还包括了那他珠单抗的准备和管理以及那他珠单抗治疗患者监测的指导。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fe86/10635346/bb339735cefd/jinfn-46-347-g005.jpg
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本文引用的文献

1
Exposure to natalizumab throughout pregnancy: effectiveness and safety in an Italian cohort of women with multiple sclerosis.整个孕期使用那他珠单抗:意大利多发性硬化症女性队列中的有效性和安全性
J Neurol Neurosurg Psychiatry. 2022 Sep 30. doi: 10.1136/jnnp-2022-329657.
2
Improvements in Cognitive Processing Speed, Disability, and Patient-Reported Outcomes in Patients with Early Relapsing-Remitting Multiple Sclerosis Treated with Natalizumab: Results of a 4-year, Real-World, Open-Label Study.在接受那他珠单抗治疗的早期复发缓解型多发性硬化症患者中,认知处理速度、残疾和患者报告结局的改善:一项为期 4 年的真实世界、开放标签研究结果。
CNS Drugs. 2022 Sep;36(9):977-993. doi: 10.1007/s40263-022-00950-0. Epub 2022 Sep 5.
3
Comparison of switching to 6-week dosing of natalizumab versus continuing with 4-week dosing in patients with relapsing-remitting multiple sclerosis (NOVA): a randomised, controlled, open-label, phase 3b trial.
在复发缓解型多发性硬化症患者中,从每周给药 4 周转换为每周给药 6 周与继续每周给药 4 周的比较(NOVA):一项随机、对照、开放标签、3b 期试验。
Lancet Neurol. 2022 Jul;21(7):608-619. doi: 10.1016/S1474-4422(22)00143-0. Epub 2022 Apr 25.
4
Multiple Sclerosis Disease Activity and Disability Following Discontinuation of Natalizumab for Pregnancy.多发性硬化症患者停止使用那他珠单抗后的疾病活动度和残疾状况与妊娠有关。
JAMA Netw Open. 2022 Jan 4;5(1):e2144750. doi: 10.1001/jamanetworkopen.2021.44750.
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Multiple sclerosis therapies differentially affect SARS-CoV-2 vaccine-induced antibody and T cell immunity and function.多发性硬化症治疗药物对 SARS-CoV-2 疫苗诱导的抗体和 T 细胞免疫及功能具有差异性影响。
JCI Insight. 2022 Feb 22;7(4):e156978. doi: 10.1172/jci.insight.156978.
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COVID-19 Vaccine Response in People with Multiple Sclerosis.COVID-19 疫苗对多发性硬化症患者的反应。
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EBioMedicine. 2021 Nov;73:103636. doi: 10.1016/j.ebiom.2021.103636. Epub 2021 Oct 16.
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EBioMedicine. 2021 Oct;72:103581. doi: 10.1016/j.ebiom.2021.103581. Epub 2021 Sep 22.
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Lancet Neurol. 2021 Aug;20(8):653-670. doi: 10.1016/S1474-4422(21)00095-8. Epub 2021 Jun 14.