那他珠单抗：复发缓解型多发性硬化症患者的安全性和风险。
Natalizumab: safety and risk in patients with relapsing-remitting multiple sclerosis.
机构信息
Pharmacy Department, Hospital Universitario Cabueñes, Gijón, Spain
Pharmacy Department, Hospital Universitario Cabueñes, Gijón, Spain.
出版信息
Eur J Hosp Pharm. 2021 Mar;28(2):112-114. doi: 10.1136/ejhpharm-2019-002048. Epub 2019 Oct 16.
OBJECTIVE
To estimate the risk of progressive multifocal leukoencephalopathy (PML) and the safety of natalizumab administration in patients with relapsing-remitting multiple sclerosis (RRMS).
METHODS
A descriptive retrospective observational study including all patients with RRMS treated with natalizumab followed-up after 10 years.The likelihood of developing PML was estimated based on three risk factors: anti-John Cunningham virus antibody index, previous immunosuppressive therapy, and duration of treatment. Patients were classified into five categories: minimum probability (<0.1/1000); low (0.1/1000); medium-low (0.2-0.6/1000); medium-high (0.8-3/1000); high probability (3-10/1000).
RESULTS
34 patients were included. The probability of PML in the last cycle was: 55.9% minimum, 8.8% low, 11.8% medium-low, 3% medium-high, and 20.5% high. 12 patients continue with active treatment with natalizumab. No cases of PML have been confirmed. Adverse effects were detected in 50% of patients.
CONCLUSIONS
Quantifying risk factors allows us to estimate the probability of PML appearance, thus assessing the maintenance or suspension of natalizumab.
目的
评估进行性多灶性白质脑病（PML）的风险和接受那他珠单抗治疗的复发缓解型多发性硬化症（RRMS）患者的安全性。
方法
本研究为描述性回顾性观察研究，纳入了所有接受那他珠单抗治疗的 RRMS 患者，随访时间超过 10 年。根据三个风险因素（抗巨细胞病毒抗体指数、先前的免疫抑制治疗和治疗持续时间）来估计发生 PML 的可能性。患者被分为五类：极小概率（<0.1/1000）；低概率（0.1/1000）；中低概率（0.2-0.6/1000）；中高概率（0.8-3/1000）；高概率（3-10/1000）。
结果
共纳入 34 例患者。最后一个周期发生 PML 的概率为：极小概率 55.9%、低概率 8.8%、中低概率 11.8%、中高概率 3%、高概率 20.5%。12 例患者继续接受那他珠单抗的积极治疗。未确诊 PML 病例。50%的患者出现了不良反应。
结论
量化风险因素可以帮助我们估计 PML 出现的概率，从而评估是否继续或暂停那他珠单抗治疗。
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