Prosperini Luca, Fanelli Fulvia, Pozzilli Carlo
Dept. of Neurology and Psychiatry, Sapienza University, Rome, Italy.
Dept. of Neurology and Psychiatry, Sapienza University, Rome, Italy.
J Neurol Sci. 2016 May 15;364:145-7. doi: 10.1016/j.jns.2016.03.025. Epub 2016 Mar 16.
In this study we assessed the proportion of patients with relapsing multiple sclerosis (R-MS) who had No Evidence of Disease Activity (NEDA-3), defined as absence of relapses, absence of confirmed disability worsening, and absence of radiological activity (detected by magnetic resonance imaging of the brain and spinal cord) up to 7years after starting natalizumab. Out of 152 patients considered, 58 were still on treatment and 94 discontinued treatment after a median time of 3years. According to an intention-to-treat approach, 52 (34%) patients maintained the NEDA status at the end of follow-up. The proportion of patients with NEDA increases to 41% after excluding from the analysis 64 patients who discontinued natalizumab due to concerns about progressive multifocal leukoencephalopathy. Our findings suggest that natalizumab may ensure higher proportion of patients achieving sustained long-term disease remission than that previously reported with self-injectable treatments (<10%).
在本研究中,我们评估了复发型多发性硬化症(R-MS)患者中达到无疾病活动证据(NEDA-3)的比例,NEDA-3定义为自开始使用那他珠单抗治疗起长达7年无复发、无确认的残疾恶化以及无放射学活动(通过脑和脊髓磁共振成像检测)。在152例纳入研究的患者中,58例仍在接受治疗,94例在中位时间3年后停止治疗。根据意向性分析方法,52例(34%)患者在随访结束时维持了NEDA状态。在分析中排除因担心进行性多灶性白质脑病而停用那他珠单抗的64例患者后,达到NEDA的患者比例增至41%。我们的研究结果表明,与之前报道的自我注射治疗(<10%)相比,那他珠单抗可能确保更高比例的患者实现持续的长期疾病缓解。