University Vita-Salute San Raffaele, San Raffaele Scientific Institute, Italy
Neurologische Klinik, Universitätsklinikum der Ruhr-Universität, Germany.
Mult Scler. 2015 May;21(6):786-90. doi: 10.1177/1352458514549404. Epub 2014 Sep 25.
In post hoc analyses of an open-label, phase 3b study (FIRST), relapse rates during 4 months of fingolimod therapy were compared in patients with and without previous natalizumab exposure. Reductions in the proportion of patients experiencing relapses and annualized relapse rates (ARRs) from years 1 and 1-2 pre-study were evident between months 1 and 2 of fingolimod treatment, and were most pronounced in natalizumab-naïve patients and those who discontinued natalizumab >6 months pre-study. Patients who discontinued natalizumab 3-6 months pre-study had a peak ARR during month 1 of fingolimod treatment, followed by a decrease during months 2-4. These data indicate that fingolimod has the potential to reduce disease reactivation but that timing of treatment initiation may be critical for achieving an optimal effect.
在一项开放性、3b 期研究（FIRST）的事后分析中，比较了有和无先前那他珠单抗暴露史的患者在接受 fingolimod 治疗 4 个月期间的复发率。从研究前 1 年和 1-2 年开始， fingolimod 治疗后 1 至 2 个月期间，复发患者的比例和年复发率（ARR）降低，在那他珠单抗初治患者和研究前停用那他珠单抗>6 个月的患者中最为明显。研究前停用那他珠单抗 3-6 个月的患者在 fingolimod 治疗的第 1 个月期间出现峰值 ARR，随后在第 2-4 个月期间下降。这些数据表明 fingolimod 具有降低疾病再激活的潜力，但治疗开始的时间可能对实现最佳效果至关重要。
