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赛诺菲的IL-4/IL-13单抗Dupixent,在特应性皮炎儿童患者中显示出明显益处

2020-04-03 MedSci原创 MedSci原创

III期试验结果显示,将Dupixent与临床护理标准局部皮质类固醇(TCS)结合使用,可显著缓解6-11岁严重特应性皮炎患者的疾病症状。

赛诺菲(Sanofi)公布了其IL-4/IL-13单抗Dupixent(dupilumab)治疗无法控制的严重特应性皮炎儿童患者的III期实验数据。

III期试验结果显示,将Dupixent与临床护理标准局部皮质类固醇(TCS)结合使用,可显著缓解6-11岁严重特应性皮炎患者的疾病症状。

在第16周时,接受Dupixent和TCS结合治疗的儿童患者获得透明或几乎透明皮肤的人数是单独使用TCS的三倍,并且三分之二以上的儿童疾病总体上改善了至少75%。

并且,接受Dupixent和TCS结合治疗的儿童患者皮肤瘙痒症状减轻的人数是单独使用TCS的三倍以上。Dupixent最早在首次给药后两周就观察到瘙痒和疾病严重程度的改善,并且在整个积极治疗中一直持续。

在安全方面,Dupixent的不良反应总发生率是每四周65%,每两周发生67%,仅TCS发生率为73%。

Dupixent是一种全人源的单克隆抗体,可抑制白介素4(IL-4)和白介素13(IL-13)蛋白的信号传导。而IL-4/IL-13在特应性皮炎、哮喘和慢性鼻窦炎伴鼻息肉中起主要作用。

该药物由赛诺菲和再生元联合开发。

原始出处:

http://www.pharmatimes.com/news/sanofi_unveils_new_data_for_dupixent_in_children_with_dermatitis_1335514

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    2020-04-05 jjjiang0202

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