那他珠单抗停药后复发风险：来自法国TYSEDMUS队列的结果。
Risk of relapse after natalizumab withdrawal: Results from the French TYSEDMUS cohort.
作者信息
Papeix Caroline, Vukusic Sandra, Casey Romain, Debard Nadine, Stankoff Bruno, Mrejen Serge, Uhry Zoe, Van Ganse Eric, Castot Anne, Clanet Michel, Lubetzki Catherine, Confavreux Christian
机构信息
Neurology Department (C.P., S.M., C.L.), Pitié-Salpêtrière Hospital, Paris; Service de Neurologie A, Hôpital Neurologique Pierre Wertheimer (S.V., C.C.), and Neuro-epidemiology and Pharmaco-epidemiology (E.V.G.), Hospices Civils de Lyon, Lyon/Bron; Centre des Neurosciences de Lyon (S.V., C.C.), INSERM 1028 et CNRS UMR5292, Equipe Neuro-oncologie et Neuro-inflammation; Université de Lyon (S.V., C.C.); Observatoire Français de la Sclérose en Plaques (R.C., N.D., Z.U.), Bron; Neurology Department (B.S.), Saint Antoine Hospital, Paris; Agence Nationale de Sécurité des Médicaments (ANSM, formerly Agence Française de Sécurité Sanitaire des Produits de Santé-AFSSAPS) (A.C.), Saint-Denis; and Neurology Department (M.C.), Purpan Hospital, Toulouse, France.
出版信息
Neurol Neuroimmunol Neuroinflamm. 2016 Oct 28;3(6):e297. doi: 10.1212/NXI.0000000000000297. eCollection 2016 Dec.
OBJECTIVE
To assess disease activity within 12 months after natalizumab (NZ) discontinuation in a large French postmarketing cohort.
METHODS
In France, patients exposed at least once to NZ were included in the TYSEDMUS observational and multicenter cohort, part of the French NZ Risk Management Plan. Clinical disease activity during the year following NZ discontinuation was assessed in this cohort. Time to first relapse after NZ stop was analyzed using Kaplan-Meier method and potentially associated factors were studied using a multivariate Cox model.
RESULTS
Out of the 4,055 patients with multiple sclerosis (MS) included in TYSEDMUS, 1,253 discontinued NZ and 715 of them had relevant data for our study. The probability of relapse within the year after NZ stop was estimated at 45% (95% confidence interval 0.41-0.49).
CONCLUSIONS
This large and systematic survey of patients with MS after NZ withdrawal allows quantifying the risk of increased disease activity following treatment discontinuation. This study provides large-scale, multicenter, systematic data after NZ cessation in real-life settings.
目的
在一个大型法国上市后队列中评估那他珠单抗（NZ）停药后12个月内的疾病活动情况。
方法
在法国，至少接受过一次NZ治疗的患者被纳入TYSEDMUS观察性多中心队列，这是法国NZ风险管理计划的一部分。在该队列中评估NZ停药后一年内的临床疾病活动情况。使用Kaplan-Meier方法分析NZ停药后首次复发的时间，并使用多变量Cox模型研究潜在的相关因素。
结果
在TYSEDMUS纳入的4055例多发性硬化症（MS）患者中，1253例停用了NZ，其中715例有本研究的相关数据。NZ停药后一年内复发的概率估计为45%（95%置信区间0.41 - 0.49）。
结论
这项对NZ停药后MS患者进行的大规模系统性调查能够量化治疗中断后疾病活动增加的风险。本研究提供了在现实生活环境中NZ停药后的大规模、多中心、系统性数据。
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