The Regional MS Center, Center for Neurological Disorders SC, Ascension St. Francis Hospital, 3237 S. 16th Street, Milwaukee, WI 53215, United States.
The Regional MS Center, Center for Neurological Disorders SC, Ascension St. Francis Hospital, 3237 S. 16th Street, Milwaukee, WI 53215, United States.
Mult Scler Relat Disord. 2023 Dec;80:105048. doi: 10.1016/j.msard.2023.105048. Epub 2023 Oct 10.
While natalizumab (NTZ) is an effective therapy for multiple sclerosis (MS), it is associated with an increased risk of progressive multifocal leukoencephalopathy (PML). After 20 years (2002-2022) of experience with NTZ at our center, we observed no cases of PML.
We evaluated the likelihood of experiencing PML in a subset of our treatment cohort, as well as reviewed treatment practices at our center that may mitigate PML risk.
For this retrospective study, we reviewed patient characteristics, treatment practices, and clinical and MRI findings in patients receiving NTZ from 2006 to 2020. Observation of no PML cases was compared to the global and US PML incidences, and to the expected incidence based on published risk estimates.
766 patients were evaluated. The number of NTZ infusions received ranged from 1 to 126, with a mean of 28. Patients received neurological examination prior to each infusion, which sometimes resulted in a pause in therapy to rule out PML if clinical worsening occurred. Extended interval dosing (EID) was the overall dosing schedule for 31% of patients. EID did not result in higher rates of radiological disease worsening than standard interval dosing (SID) patients. Depending on the analysis conducted, the finding of 0 PML cases in our cohort ranged from slightly unexpected to slightly expected.
The utilization of EID as well as regular clinical monitoring of patients may have lowered PML risk while still maintaining NTZ efficacy.
虽然那他珠单抗（NTZ）是多发性硬化症（MS）的有效治疗方法，但它与进行性多灶性白质脑病（PML）的风险增加有关。在我们中心使用 NTZ 20 年（2002-2022 年）后，我们没有观察到 PML 病例。
我们评估了我们治疗队列中的一部分患者发生 PML 的可能性，并回顾了我们中心可能降低 PML 风险的治疗实践。
对于这项回顾性研究，我们回顾了 2006 年至 2020 年间接受 NTZ 治疗的患者的人口统计学特征、治疗实践以及临床和 MRI 发现。观察到没有 PML 病例与全球和美国的 PML 发病率以及根据已发表的风险估计预期的发病率进行了比较。
共评估了 766 例患者。接受的 NTZ 输注次数从 1 次到 126 次不等，平均为 28 次。在每次输注前，患者都接受了神经系统检查，如果临床恶化，有时会暂停治疗以排除 PML。31%的患者采用了延长间隔给药（EID）。EID 并未导致影像学疾病恶化的发生率高于标准间隔给药（SID）患者。根据进行的分析，我们队列中 0 例 PML 病例的发现结果从略出乎意料到略预期不等。
EID 的使用以及对患者的定期临床监测可能降低了 PML 风险，同时仍保持了 NTZ 的疗效。
