视Inebilizumab治疗neuromyelitis谱系障碍(N-MOmentum):双盲随机安慰剂对照2/3阶段试验。

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班纳特克里族BAC,杰,Kim HJ Weinshenker BG, Pittock SJ, Wingerchuk DM,藤K,保罗•F刀GR, Marignier R,绿色AJ, Aktas啊,哈惠普,卢布林FD, Drappa J,巴伦G, Madani年代,Ratchford认为约,这项她D, Katz Cimbora D, E

视Inebilizumab治疗neuromyelitis谱系障碍(N-MOmentum):双盲随机安慰剂对照2/3阶段试验。

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。

PubMed ID

31495497 (在PubMed

]

文摘

背景:没有批准治疗存在视neuromyelitis谱系障碍(NMOSD),一种罕见的、复发、自身免疫、炎症性疾病的中枢神经系统,导致失明和瘫痪。我们旨在评估inebilizumab的疗效和安全性,anti-CD19, B cell-depleting抗体,在NMOSD降低攻击和残疾的风险。方法:我们做了一个多中心、双盲随机安慰剂对照阶段2/3研究99年门诊专业诊所或医院在25个国家。合格参与者成年人(> / = 18岁)诊断NMOSD,扩大残疾状态量表得分为8.0或更低,和至少一个攻击的历史要求救助治疗前一年筛查或至少两个攻击需要救援疗法在检查前2年。参与者被随机分配(3:1)与中央静脉inebilizumab 300毫克或安慰剂交互式语音应答系统或网络反应系统和随机排列块。Inebilizumab或安慰剂是管理在第1和15天。参与者,调查人员,所有治疗临床工作人员戴面具,inebilizumab和安慰剂在外表上是没有区别的。主要终点是时候开始一个NMOSD攻击,由审判委员会决定。疗效端点进行评估在所有随机分配病人至少一个剂量的干预研究,评估和安全端点as-treated人口。这项研究是在ClinicalTrials.gov注册,NCT02200770数量。 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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药物

Inebilizumab