PT -期刊文章盟佐伊L.E. van Kempen AU -欧文第50 Hoogervorst AU -迈克·p·Wattjes盟Nynke f . Kalkers AU - Jop p .便宜盟Birgit i Lissenberg-Witte AU - Annick de Vries盟安雅十Brinke AU -鲍勃·w·范·Oosten盟弗雷德里克Barkhof AU -夏洛特大肠Teunissen盟伯纳德M.J. Uitdehaag AU -沃尔Rispens盟•Killestein TI -个性化扩展区间剂量natalizumab援助- 10.1212 / WNL女士。0000000000009995 DP - 2020年8月11日TA -神经病首页学PG - e745 e754 VI - 95 IP - 6 4099 - //www.ez-admanager.com/content/95/6/e745.short 4100 - //www.ez-admanager.com/content/95/6/e745.full所以Neurology2020 8月11;95 AB -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。 Median EDSS was comparable at baseline (3.0, interquartile range [IQR] 2.0–5.0) and after follow-up (3.0, IQR 2.0–5.0).Conclusion Personalized extended interval dosing did not induce recurrence of MS disease activity. 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