Department of Neurology, Medical University of Innsbruck, Anichstraße 35, 6020, Innsbruck, Austria.
Department of Neurology, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Wien, Austria.
Sci Rep. 2021 Dec 2;11(1):23317. doi: 10.1038/s41598-021-02665-6.
Natalizumab (NTZ) has been used for treatment of highly active relapsing-remitting multiple sclerosis (MS). When stopping NTZ the risk of severe rebound phenomenon has to be considered. We aimed to investigate the use of NTZ in clinical routine and focused on identification of potential risk factors for disease reactivation after treatment discontinuation. At the Medical University of Innsbruck, Austria, we identified all MS patients who were treated with NTZ and performed a retrospective analysis on therapeutic decision making, disease course before, during and after treatment with NTZ and on risk factors for disease reactivation after NTZ discontinuation. 235 NTZ treated MS patients were included, of whom 105 had discontinued treatment. At NTZ start disease duration was 5.09 (IQR 2.09-10.57) years, average number of total relapses was 4 (IQR 3-6) and median EDSS 2.0 (range 0-6.5), whereby these values significantly decreased over time. Reduction of annualized relapse rate (ARR) on treatment was 93% and EDSS remained stable in 64%. In multivariate regression models only conversion to secondary progressive MS (SPMS) on treatment was significantly associated with lower risk of disease reactivation after NTZ, while ARR before treatment was associated with earlier disease reactivation. We could confirm the high therapeutic efficacy of NTZ which trends to be used earlier in the disease course nowadays. Discontinuation of NTZ seems safe only in patients who convert to SPMS during treatment, while higher ARR before NTZ increases the risk of disease reactivation after treatment discontinuation.
那他珠单抗（NTZ）已被用于治疗高度活跃的复发缓解型多发性硬化症（MS）。当停止使用 NTZ 时，必须考虑严重反弹现象的风险。我们旨在调查 NTZ 在临床常规中的使用情况，并重点研究治疗停止后疾病复发的潜在危险因素。在奥地利因斯布鲁克医科大学，我们确定了所有接受 NTZ 治疗的 MS 患者，并对治疗决策、治疗前、治疗中和治疗后疾病过程以及 NTZ 停药后疾病复发的危险因素进行了回顾性分析。共纳入 235 例接受 NTZ 治疗的 MS 患者，其中 105 例已停药。NTZ 开始时的疾病持续时间为 5.09 年（IQR 2.09-10.57），总复发次数平均为 4 次（IQR 3-6），EDSS 中位数为 2.0 分（范围 0-6.5），这些值随时间显著降低。治疗期间的年化复发率（ARR）降低了 93%，EDSS 稳定在 64%。在多变量回归模型中，只有治疗中转为继发进展型 MS（SPMS）与 NTZ 停药后疾病复发风险降低显著相关，而治疗前的 ARR 与疾病更早复发相关。我们可以证实 NTZ 的高治疗效果，现在这种药物在疾病过程中更早使用的趋势。只有在治疗过程中转为 SPMS 的患者停止使用 NTZ 似乎是安全的，而 NTZ 前更高的 ARR 会增加治疗停止后疾病复发的风险。
