Puthenparampil Marco, Cazzola Chiara, Zywicki Sofia, Federle Lisa, Stropparo Erica, Anglani Mariagiulia, Rinaldi Francesca, Perini Paola, Gallo Paolo
Multiple Sclerosis Centre, Department of Neuroscience DNS, Univeristà Degli Studi di Padova, Via Giustinaini 2, 35128, Padova, Italy.
Multiple Sclerosis Centre, Department of Neuroscience DNS, University of Padua, Padua, Italy.
Ther Adv Neurol Disord. 2018 Oct 25;11:1756286418805713. doi: 10.1177/1756286418805713. eCollection 2018.
Cortical lesions (CLs) are typical of multiple sclerosis (MS) and have been recently incorporated in MS diagnostic criteria. Thus, the 'no evidence of disease activity' (NEDA) definition should now include CLs. The aim of this study was to evaluate the NEDA3 + CL status in natalizumab- or fingolimod-treated relapsing remitting MS (RMS) patients.
Natalizumab- or fingolimod-treated RMS patients were enrolled in a 2-year longitudinal study based on clinical and magnetic resonance imaging (MRI) evaluations performed respectively biannually and annually. CLs were detected by double inversion recovery. The NEDA3 + CL condition was evaluated at baseline (T0) and at the end of the first (T1) and second (T2) year.
Of the 137 RMS patients included in the study, 86 were propensity-matched. At T2, the annualized relapse rate was lower on natalizumab ( = 0.021), but the effect on white matter lesions ( = 0.29) and the proportion of NEDA-3 patients ( = 0.14) were similar in the two treatment arms. At T2, 11.6% natalizumab- and 62.8% fingolimod-treated patients had new CLs ( < 0.001) and a higher proportion of natalizumab-treated patients (55.8% 11.6%, < 0.001) achieved the NEDA3 + CL status (hazard ratio 5.2, < 0.001).
The incorporation of CLs in the NEDA-3 definition highlighted the higher efficacy of natalizumab fingolimod in suppressing disease activity in RMS patients.
皮质病变（CLs）是多发性硬化症（MS）的典型特征，最近已被纳入MS诊断标准。因此，“无疾病活动证据”（NEDA）定义现在应包括CLs。本研究的目的是评估那他珠单抗或芬戈莫德治疗的复发缓解型MS（RMS）患者的NEDA3+CL状态。
那他珠单抗或芬戈莫德治疗的RMS患者参加了一项为期2年的纵向研究，分别基于每半年和每年进行的临床和磁共振成像（MRI）评估。通过双反转恢复检测CLs。在基线（T0）以及第一（T1）和第二（T2）年结束时评估NEDA3+CL状况。
纳入研究的137例RMS患者中，86例进行了倾向匹配。在T2时，那他珠单抗治疗组的年化复发率较低（=0.021），但两个治疗组对白质病变的影响（=0.29）和NEDA-3患者的比例（=0.14）相似。在T2时，那他珠单抗治疗组有11.6%的患者出现新的CLs，芬戈莫德治疗组为62.8%（<0.001），且那他珠单抗治疗组达到NEDA3+CL状态的患者比例更高（55.8%对11.6%，<0.001）（风险比5.2，<0.001）。
将CLs纳入NEDA-3定义突出了那他珠单抗比芬戈莫德在抑制RMS患者疾病活动方面具有更高的疗效。
