Gastroenterology:RPC4046可降低嗜酸性粒细胞性食管炎患者的组织学和内镜疾病活动

2019-03-05 不详 MedSci原创

嗜酸粒细胞性食管炎(EoE)是一种慢性的食管2型炎症反应,它的出现与白细胞介素13(IL13)血清水平升高有关。RPC4046是一种针对IL13的重组人源化单克隆抗体,可阻止其与受体亚单位IL13RA1和IL13RA2的结合。本项研究旨在评估RPC4046在EoE患者中的有效性和安全性。

背景和目标
嗜酸粒细胞性食管炎(EoE)是一种慢性的食管2型炎症反应,它的出现与白细胞介素13(IL13)血清水平升高有关。RPC4046是一种针对IL13的重组人源化单克隆抗体,可阻止其与受体亚单位IL13RA1和IL13RA2的结合。本项研究旨在评估RPC4046在EoE患者中的有效性和安全性。

方法
研究人员对2014年9月至2015年12月间确诊为EoE的99名患者每周一次给予RPC4046(180或360 mg)或安慰剂治疗,持续16周。在第1天(基线)和第2,4,8,12和16周观察他们。所有患者均接受了食管十二指肠镜检查,并在基线和第16周获取了活检组织。患者在第16周完成了每日吞咽困难症状记录。主要观察结果是观察具有最高炎症水平的5个高倍视野(hpfs)中平均食道嗜酸性粒细胞计数的变化。

结果
在第16周,接受180毫克RPC4046治疗的食管嗜酸性粒细胞每高倍视野数降低94.8±67.3,接受360毫克谁收到180毫克RPC4046治疗的患者每高倍视野数降低99.9±79.5,与安慰剂组相比,360 mg RPC4046组在所有食管部位均显示有效内镜严重程度评分显着降低(P<.0001),组织学分级也明显下降(均P <.0001); 而且吞咽困难症状记录得分数值有所下降(P = .0733)。在接受RPC4046的类固醇难治性EoE患者中观察到食管嗜酸性粒细胞计数和组织学和内镜特征的显着降低。最常见的不良事件是头痛和上呼吸道感染

结论
本项研究发现与安慰剂相比,RPC4046(针对IL13的单克隆抗体)可减少EoE组织学和内镜下炎症表现。

原始出处:

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    2020-01-26 许安
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  8. 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    2019-03-07 zhouqu_8
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