Gastroenterology:MEDI2070单抗治疗克罗恩病

2017-04-10 zhangfan MedSci原创

对于肿瘤坏死因子抑制剂治疗失败的中重度克罗恩病患者MEDI2070单抗可以有效的缓临床疾病症状

MEDI2070为试验性人源单克隆抗体,可以选择性地抑制白细胞介素23(IL-23)细胞因子用于克罗恩病的治疗,研究人员就MEDI2070在CD治疗的安全性和有效性开展了IIa期研究。

在这项双盲、安慰剂对照研究中,119名肿瘤坏死因子抑制剂治疗失败的中重度克罗恩病患者随机在治疗的第0和4周接受MEDI2070 (700 mg) 或安慰剂。从治疗的第12周至112周,每4周患者接受210mg的MEDI2070。CD活动指数(CDAI)是用来衡量疾病程度。

本试验的主要终点为临床应答(CDAI分数较基线下降100分或临床缓解[分数低于150分])。 试验结果显示, MEDI2070组在8周的终点达到率为49.2%(n=59)安慰剂组为26.7(n=60);24周的终点达到率MEDI2070持续组为53.8%,安慰剂+MEDI2070治疗组为57.7%。最常见的不良反应为头痛、鼻咽炎,MEDI2070组的血清IL22浓度较安慰剂组稍高。

试验表明,对于肿瘤坏死因子抑制剂治疗失败的中重度克罗恩病患者MEDI2070单抗可以有效的缓临床疾病症状。

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