Effect of the complement inhibitor eculizumab on thromboembolism in patients with paroxysmal nocturnal hemoglobinuria
Effect of the complement inhibitor eculizumab on thromboembolism in patients with paroxysmal nocturnal hemoglobinuria
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DOI：
10.1182/blood-2007-06-095646
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发表时间：
2007-12-01
期刊：
影响因子：
20.3
通讯作者：
Young, Neal S.
中科院分区：
文献类型：
--
作者：
Hillmen, Peter;Muus, Petra;Young, Neal S.
溶血和血红蛋白血症会导致严重的溶血性疾病的临床后遗症。在阵发性睡眠性血红蛋白尿(PNH)患者中，溶血可导致血栓栓塞症(TIE)，这是PNH最可怕的并发症，也是与疾病相关的死亡的主要原因。我们评估了补体抑制剂eculizumab的长期治疗是否降低了PNH患者的TIE发生率。临床试验参与者包括3项eculizumab PNH临床研究中的所有患者，这些研究在2002至2005年间招募了患者(n=195)；这些研究的患者在当前的多国开放标签扩展研究中继续治疗。比较治疗前与治疗前的血栓栓塞率。Eulizurnab组的TE事件发生率为1.07次/100人年，而Eulizurnab组为7.37次/100人年(P
Hemolysis and hemoglobinemia contribute to serious clinical sequelae in hemolytic disorders. In paroxysmal nocturnal hemoglobinuria (PNH) patients, hemolysis can contribute to thromboembolism (TIE), the most feared complication in PNH, and the leading cause of disease-related deaths. We evaluated whether long-term treatment with the complement inhibitor eculizumab reduces the rate of TIE in patients with PNH. Clinical trial participants included all patients in the 3 eculizumab PNH clinical studies, which recruited patients between 2002 and 2005 (n = 195); patients from these studies continued treatment in the current multinational open-label extension study. Thromboembolism rate with eculizumab treatment was compared with the pretreatment rate in the same patients. The TE event rate with eculizurnab treatment was 1.07 events/100 patient-years compared with 7.37 events/100 patient-years (P