TY -的T1 -从natalizumab转向fingolimod JF -神经学乔-神经病学SP - 29 LP - 3首页9 - 10.1212 / WNL。0000000000001706六世- 85 - 1 AU -路德维希卡波斯盟Ernst-Wilhelm Radue AU -吉安卡洛Comi盟Xavier好吃的AU -赫尔穆特•Butzkueven AU -海因茨Wiendl盟Gavin Giovannoni AU -汉斯哈AU - Tobias Derfuss盟伊冯Naegelin AU -直到斯派格盟妮可Mueller-Lenke AU -莎拉·格里菲思盟-菲利普·冯·罗森斯蒂尔AU -丽贝卡Gottschalk以及非盟-应张盟-弗兰克Dahlke盟Davorka Tomic Y1 - 2015/07/07 UR - //www.ez-admanager.com/content/85/1/29.abstract N2 -目的:探讨不同natalizumab冲刷的影响(我们)在MRI和临床疾病的复发时间活动从natalizumab转向fingolimod的病人。首页方法:多中心、双盲、安慰剂对照试验(TOFINGO),患者复发缓和多发性硬化(名RRMS)被随机比8 - 12或16周我跟着fingolimod治疗在32周从去年natalizumab注入(LNI)。大脑核磁共振进行基线和8周,12、16、20日和24日。结果:142注册和随机化患者,112例(78.9%)完成了研究(8周,n = 41/50;12周,n = 31/42;16周,n = 40/50)。号码(95%可信区间[CI])的活跃(新/新扩大的T2)病变通过8周LNI fingolimod治疗(主要结果)类似于8周(2.1[1.7—-2.6]),12周我们组(1.7[1.3—-2.2])和更高的16周我们组(8.2 [7.3—-9.1])。我们期间,活跃的数量(95% CI)病变随着我们持续时间的增加而增加(8周,0.4 (0.2 - -0.6);12周,2.1 (1.6 - -2.6);16周,3.6 [3.0 - -4.2])。 Over the 24 weeks from LNI, gadolinium-enhancing T1 lesion counts were lower in the 8-week WO group (14.1 [5.67–22.53]) than in the 12-week (21.3 [1.41–41.19]) or 16-week (18.5 [8.40–28.60]) WO groups. More patients were relapse-free in the 8-week (88%) and 12-week (91%) WO groups than the 16-week WO group (84%). Sixty-eight percent of patients experienced adverse events (mostly mild/moderate), with similar incidence across groups. No unusually severe relapses or opportunistic infections occurred.Conclusions: Initiating fingolimod therapy 8–12 weeks after natalizumab discontinuation is associated with a lower risk of MRI and clinical disease reactivation than initiation after 16-week WO.Classification of evidence: This study provides Class II evidence that for patients with RRMS switching from natalizumab to fingolimod, shorter natalizumab WO periods are associated with less MRI disease activity than are longer WO periods.AE=adverse event; EDSS=Expanded Disability Status Scale; FAS=full analysis set; Gd+=gadolinium-enhancing; JCV=JC virus; LNI=last natalizumab infusion; MS=multiple sclerosis; P90=90th percentile; PML=progressive multifocal leukoencephalopathy; RRMS=relapsing-remitting multiple sclerosis; SAE=serious adverse event; SS=safety set; TSQM-9=Treatment Satisfaction Questionnaire for Medication–9; WO=washout ER -