Goodin D S, Cohen B A, O'Connor P, Kappos L, Stevens J C
University of California at San Francisco, USA.
Neurology. 2008 Sep 2;71(10):766-73. doi: 10.1212/01.wnl.0000320512.21919.d2.
The clinical and radiologic impact of natalizumab (Tysabri) as therapy for multiple sclerosis (MS) is assessed. On the basis of Class I evidence, natalizumab has been demonstrated to reduce measures of disease activity and to improve measures of disease severity in patients with relapsing-remitting (RR) MS (Level A). The relative efficacy of natalizumab compared to current disease-modifying therapies cannot be defined accurately (Level U). Similarly, the value of natalizumab in the treatment of secondary progressive (SP) MS is unknown (Level U). The value of combination therapy using natalizumab and interferon in the treatment of RRMS is also unknown (Level U). There is an increased risk of developing progressive multifocal leukoencephalopathy (PML) in natalizumab-treated patients (Level A for combination therapy, Level C for monotherapy) and possibly an increased risk of other opportunistic infections (Level C). The PML risk in a pooled clinical trial cohort has been estimated to be 1 person for every 1,000 patients treated for an average of 17.9 months, although this figure could change in either direction with more experience with the drug.
评估了那他珠单抗（泰萨比）作为多发性硬化症（MS）治疗方法的临床和影像学影响。基于I类证据，已证明那他珠单抗可降低复发缓解型（RR）MS患者的疾病活动度指标，并改善疾病严重程度指标（A级）。那他珠单抗与目前疾病修饰疗法相比的相对疗效尚无法准确界定（U级）。同样，那他珠单抗在继发进展型（SP）MS治疗中的价值也未知（U级）。那他珠单抗与干扰素联合治疗RRMS的价值也未知（U级）。接受那他珠单抗治疗的患者发生进行性多灶性白质脑病（PML）的风险增加（联合治疗为A级，单药治疗为C级），其他机会性感染的风险可能也会增加（C级）。在一项汇总的临床试验队列中，PML风险估计为每1000例接受平均17.9个月治疗的患者中有1例，不过随着对该药物更多的使用经验，这一数字可能会向任何一个方向变化。
