Inebilizumab治疗视神经脊髓炎谱系障碍(N-MOmentum):一项双盲、随机安慰剂对照2/3期试验
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Cree BAC, Bennett JL, Kim HJ, Weinshenker BG, Pittock SJ, Wingerchuk DM, Fujihara K, Paul F, Cutter GR, Marignier R, Green AJ, Aktas O, Hartung HP，卢布林FD, Drappa J, Barron G, Madani S, Ratchford JN, She D, Cimbora D, Katz E
Inebilizumab治疗视神经脊髓炎谱系障碍(N-MOmentum):一项双盲、随机安慰剂对照2/3期试验
柳叶刀。2019年10月12日;394(10206):1352-1363。doi: 10.1016 / s0140 - 6736(19) 31817 - 3。Epub 2019 9月5日。
- PubMed ID
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31495497 (PubMed视图］
- 摘要
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背景:目前还没有批准的治疗视神经脊髓炎谱系障碍(NMOSD)的治疗方法，NMOSD是一种罕见的、复发的、自身免疫性的中枢神经系统炎症性疾病，可导致失明和瘫痪。我们旨在评估抗cd19 B细胞消耗抗体inebilizumab在降低NMOSD发作和残疾风险方面的有效性和安全性。方法:我们在25个国家的99个门诊专科诊所或医院进行了一项多中心、双盲、随机安慰剂对照2/3期研究。符合条件的参与者为成人(>/=18岁)，诊断为NMOSD，扩展残疾状态量表得分为8.0或以下，筛查前一年至少有一次需要抢救治疗的发作史，或筛查前2年至少有两次需要抢救治疗的发作史。参与者被随机分配(3:1)300 mg静脉注射依奈比利单抗或安慰剂，采用中央交互式语音应答系统或交互式网络响应系统，并进行排列分组随机。在第1天和第15天给予依奈比利单抗或安慰剂。参与者、研究人员和所有临床工作人员对治疗进行了掩盖，并且依奈比利单抗和安慰剂在外观上没有区别。主要终点是NMOSD发作的时间，由审判委员会确定。在所有接受至少一剂研究干预的随机分配患者中评估疗效终点，在接受治疗的人群中评估安全性终点。该研究已在ClinicalTrials.gov注册，注册号为NCT02200770。 FINDINGS: Between Jan 6, 2015, and Sept 24, 2018, 230 participants were randomly assigned to treatment and dosed, with 174 participants receiving inebilizumab and 56 receiving placebo. The randomised controlled period was stopped before complete enrolment, as recommended by the independent data-monitoring committee, because of a clear demonstration of efficacy. 21 (12%) of 174 participants receiving inebilizumab had an attack versus 22 (39%) of 56 participants receiving placebo (hazard ratio 0.272 [95% CI 0.150-0.496]; p<0.0001). Adverse events occurred in 125 (72%) of 174 participants receiving inebilizumab and 41 (73%) of 56 participants receiving placebo. Serious adverse events occurred in eight (5%) of 174 participants receiving inebilizumab and five (9%) of 56 participants receiving placebo. INTERPRETATION: Compared with placebo, inebilizumab reduced the risk of an NMOSD attack. Inebilizumab has potential application as an evidence-based treatment for patients with NMOSD. FUNDING: MedImmune and Viela Bio.
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