Crizanlizumab预防危机镰状细胞病的痛苦。

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Ataga KI, Kutlar坎特J, Liles D, Cancado R, Friedrisch J,格思里,Knight-Madden J,阿尔瓦雷斯OA, Gordeuk VR, Gualandro年代,Colella议员史密斯WR,罗林斯SA储料器JW,洛特RP

Crizanlizumab预防危机镰状细胞病的痛苦。

郑传经地中海J。2017年2月2,376 (5):429 - 439。doi: 10.1056 / NEJMoa1611770。Epub 2016年12月3。

PubMed ID

27959701 (在PubMed

]

文摘

背景:P-selectin老年病的内皮细胞和血小板导致的信息交互参与vaso-occlusion和镰状闲暇的疼痛的发病机制的危机。crizanlizumab的安全性和有效性,对粘附分子P-selectin抗体,镰状细胞病的患者进行评估。方法:在这个双盲,随机,安慰剂对照,第二阶段试验,我们分配患者接受低剂量crizanlizumab(每公斤体重2.5毫克),高剂量crizanlizumab(5.0毫克/千克),或安慰剂,静脉注射14倍的52周。患者接受伴随羟基脲以及那些没有得到羟基脲被纳入研究。主要终点是镰状闲暇的疼痛危机的年增长率与高剂量crizanlizumab和安慰剂。天住院的年增长率,第一次和第二次危机,年利率的简单的危机(定义为危机除了急性胸部综合症,肝固,固脾,或阴茎持续勃起症)和急性胸部综合征,和patient-reported结果也被评估。结果:共有198名患者进行了随机化60网站。平均每年危机与大剂量crizanlizumab 1.63和2.98与安慰剂(指示与高剂量crizanlizumab率低45.3%,P = 0.01)。中位数时间第一个危机大大延长与高剂量crizanlizumab比安慰剂(4.07和1.38个月,P = 0.001),就像第二个危机的平均时间(10.32和5.09个月,P = 0.02)。简单的危机的平均速度与高剂量crizanlizumab每年为1.08,与安慰剂相比,2.91(指示与高剂量crizanlizumab率低62.9%,P = 0.02)。 Adverse events that occurred in 10% or more of the patients in either active-treatment group and at a frequency that was at least twice as high as that in the placebo group were arthralgia, diarrhea, pruritus, vomiting, and chest pain. CONCLUSIONS: In patients with sickle cell disease, crizanlizumab therapy resulted in a significantly lower rate of sickle cell-related pain crises than placebo and was associated with a low incidence of adverse events. (Funded by Selexys Pharmaceuticals and others; SUSTAIN ClinicalTrials.gov number, NCT01895361 .).

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药物

Crizanlizumab