Clinic for Neurology 2, Med Campus III, Kepler University Clinic, Krankenhausstrasse 9, 4021, Linz, Austria.
Department of Neurology, Medical University of Graz, Graz, Austria.
J Neurol. 2019 Nov;266(11):2672-2677. doi: 10.1007/s00415-019-09464-0. Epub 2019 Jul 16.
To compare the efficacy of natalizumab (NTZ) and fingolimod (FTY) in the treatment of relapsing-remitting multiple sclerosis (MS) in sequential use in common and as a function of transition periods in a nationwide observational cohort using prospectively collected data from a real-life setting.
We included 195 patients from the Austrian MS Treatment Registry, who had started treatment with NTZ at any time since 2006 and stayed on NTZ for at least 24 months, switched afterwards within 1 year to FTY and stayed on FTY for at least another 12 months. Transition periods between NTZ and FTY were grouped into three different intervals: < 3 months (135 patients), 3-6 months (44 patients), and 6-12 months (16 patients).
Estimated mean annualized relapse rates (ARR) over a mean treatment period of 44 months were 0.26 for NTZ and 0.32 for FTY (p = 0.381) over 46 months. In the treatment gap, differences were found concerning the relapse probability, seven (5.2%) patients in the < 3 months group, six (13.6%) in thef 3-6 months group, and seven (43.8%) in the 6-12 months group (p < 0.001). After this treatment gap, no significant differences concerning ARR, EDSS change, EDSS progression, and regression were observed regardless the proceeding transition periods. Significantly higher efficacy of NTZ compared to FTY in sequential use was found regarding EDSS change, EDSS progression, and EDSS regression sustained for 12 and 24 weeks.
First, we here show an increased short-time risk for relapses during the treatment gap between NTZ and FTY therapy, dependent on the length of transition time. Second, the disease course after switching to FTY remained stable in the long-term evaluation. Therefore, switching from NTZ to FTY in a real-world setting appears efficacious and safe, but this data advocate for a short switching gap of 3 months or less.
比较那他珠单抗（NTZ）和芬戈莫德（FTY）在连续使用及作为转换期功能在全国性观察队列中的疗效，该队列使用真实环境中前瞻性收集的数据对复发缓解型多发性硬化症（MS）进行治疗。
我们纳入了奥地利 MS 治疗登记处的 195 名患者，他们自 2006 年以来任何时间开始接受 NTZ 治疗，且至少连续使用 NTZ 24 个月，随后在 1 年内转换为 FTY，并至少再使用 FTY 12 个月。NTZ 和 FTY 之间的转换期分为三组不同的间隔：<3 个月（135 例）、3-6 个月（44 例）和 6-12 个月（16 例）。
在平均 44 个月的治疗期间，估计平均年化复发率（ARR）分别为 NTZ 组 0.26 和 FTY 组 0.32（p=0.381）。在治疗空白期，关于复发的概率存在差异，在<3 个月组中有 7 例（5.2%），在 3-6 个月组中有 6 例（13.6%），在 6-12 个月组中有 7 例（43.8%）（p<0.001）。在这个治疗空白期之后，无论随后的转换期如何，ARR、EDSS 变化、EDSS 进展和回归均未观察到显著差异。在连续使用中，与 FTY 相比，NTZ 的疗效显著更高，表现在 EDSS 变化、EDSS 进展和 EDSS 回归持续 12 和 24 周。
首先，我们在这里显示，在 NTZ 和 FTY 治疗之间的治疗空白期间，复发的短期风险增加，且取决于转换时间的长短。其次，在长期评估中，转换为 FTY 后的疾病过程保持稳定。因此，在真实环境中从 NTZ 切换到 FTY 似乎是有效和安全的，但这些数据主张转换间隔应尽量短，<3 个月。
