BACKGROUND Data are needed on long-term effect of natalizumab (NTZ) in relapsing-remitting multiple sclerosis (RRMS). OBJECTIVES To evaluate the time of onset of secondary progressive phase in patients with an RRMS treated with NTZ and to investigate predictive factors. METHODS TYSTEN is an observational study. Patients starting NTZ between 2007 and 2012 were included and followed up until October 2018. Relapses, Expanded Disability Status Scale (EDSS) scores, and results of brain magnetic resonance imaging (MRI) were collected each year. Data were used to estimate the cumulative probability of several poor outcomes such as secondary progressive multiple sclerosis (SPMS) conversion, EDSS worsening, EDSS 4.0, and EDSS 6.0. RESULTS 770 patients were included. The mean follow-up duration was 97 months and the mean time exposure to NTZ was 66 months. At 10 years, the cumulative probability of SPMS was 27.7%. Predictive factors for poor outcomes were a ⩾1-point increase in EDSS score from baseline, new T2 lesion or T1 gadolinium-enhancing lesion, the occurrence of relapse at 1 or 2 years and No Evidence of Disease Activity (NEDA-3; no relapse, no new T2 or T1 gadolinium-enhancing lesions, no progression) was a protective factor. CONCLUSION In our cohort of patients treated with NTZ, poor outcomes were infrequent and are driven by disease activity.

中文翻译：

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那他珠单抗对 RRMS 患者的长期影响：TYSTEN 队列

背景需要关于那他珠单抗 (NTZ) 在复发缓解型多发性硬化症 (RRMS) 中的长期影响的数据。目的 评估接受 NTZ 治疗的 RRMS 患者继发性进展期的发生时间并研究预测因素。方法 TYSTEN 是一项观察性研究。纳入 2007 年至 2012 年期间开始使用 NTZ 的患者并随访至 2018 年 10 月。每年收集复发、扩展残疾状态量表 (EDSS) 评分和脑磁共振成像 (MRI) 结果。数据用于估计几种不良结果的累积概率，例如继发性进行性多发性硬化 (SPMS) 转换、EDSS 恶化、EDSS 4.0 和 EDSS 6.0。结果 包括 770 名患者。平均随访时间为 97 个月，接触 NTZ 的平均时间为 66 个月。10 年时，SPMS 的累积概率为 27.7%。不良结局的预测因素是 EDSS 评分比基线增加 ⩾ 1 分、新的 T2 病变或 T1 钆增强病变、1 或 2 年复发和无疾病活动证据（NEDA-3；无复发） ，没有新的 T2 或 T1 钆增强病变，没有进展）是保护因素。结论 在我们接受 NTZ 治疗的患者队列中，不良结果并不常见，并且是由疾病活动驱动的。无进展）是一个保护因素。结论 在我们接受 NTZ 治疗的患者队列中，不良结果并不常见，并且是由疾病活动驱动的。无进展）是一个保护因素。结论 在我们接受 NTZ 治疗的患者队列中，不良结果并不常见，并且是由疾病活动驱动的。