% 0期刊文章%佐伊L.E. van Kempen % Erwin第50 Hoogervorst %迈克·p·Wattjes % Nynke f . Kalkers % Jop p .便宜%一个Annick de Vries Birgit i Lissenberg-Witte % %安雅十Brinke %一个鲍勃·w·范·Oosten %弗雷德里克Barkhof %夏洛特大肠Teunissen %伯纳德M.J. Uitdehaag %一个•Killestein Theo Rispens % % T个性化扩展区间剂量natalizumab女士%的前瞻性多中心试验B % D R 10.1212 / WNL 2020%。0000000000009995 % J首页神经病学% P e745-e754 % V 95% N 6% X目的确定natalizumab功效是否维护时切换到个性化扩展基于个人natalizumab槽间隔给药浓度复发缓和多发性硬化患者(名RRMS)。单组试验方法这是一个前瞻性多中心和1年随访一年扩展阶段。参与者成年残疾人名RRMS对待natalizumab入学前没有今年疾病活动。natalizumab治疗间隔是基于纵向natalizumab槽浓度。患者接受3月核磁共振扫描,复发评估,和残疾得分在随访中。主要终点是在MRI钆增强病变的发生。二级端点是新的/扩大T2病灶MRI和复发和进展扩大残疾状态量表(eds)在后续和扩展阶段。结果六十一例患者包括在内。百分之八十四延长了区间从四周间隔5 - 7周时间间隔。没有病人钆增强病变发展(95%可信区间[CI] 0% -7.4%)在随访中。没有新的/扩大T2病灶(95% CI 0% -7.4%)或复发(95% CI 0% -7.4%)在后续报道,在扩展阶段。中位数eds在基线可比性(3.0,四分位范围(差)2.0 - -5.0)后,后续(3.0,差2.0 - -5.0)。结论个性化扩展区间剂量没有引起复发的疾病活动。 Natalizumab efficacy was maintained in stable patients with RRMS receiving personalized extended interval dosing based on individual natalizumab concentrations.Classification of evidence This study provides Class IV evidence that personalized extended interval dosing of natalizumab does not result in recurrence of disease activity in stable patients with RRMS.9HPT=9-hole peg test; AUMC=Amsterdam University Medical Center; CI=confidence interval; DSMB=data safety monitoring board; EDSS=Expanded Disability Status Scale; FLAIR=fluid-attenuated inversion recovery; Gd+=gadolinium-enhancing; IQR=interquartile range; JCV=John Cunningham virus; MFI=mean fluorescence intensity; MS=multiple sclerosis; MSFC=Multiple Sclerosis Functional Composite; MSIS-29=29-item Multiple Sclerosis Impact Scale; NfL=neurofilament light; PASAT=paced auditory serial addition test; PML=progressive multifocal leukoencephalopathy; RRMS=relapsing-remitting multiple sclerosis; SF-36=36-item Short Form Health Survey; T25FW=timed 25-foot walk %U //www.ez-admanager.com/content/neurology/95/6/e745.full.pdf