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嗜酸性食管炎的首个治疗性批准

First Therapeutic Approval for Eosinophilic Esophagitis.

作者信息

Al-Horani Rami A, Chiles Raquel

机构信息

Division of Basic Pharmaceutical Sciences, College of Pharmacy, Xavier University of Louisiana, New Orleans, LA 70125, USA.

出版信息

Gastroenterol Insights. 2022 Sep;13(3):238-244. doi: 10.3390/gastroent13030024. Epub 2022 Jul 30.

Abstract

Eosinophilic esophagitis (EE) is a chronic, immune-mediated or antigen-mediated esophageal disease. Treatment for patients with EE can be challenging with no previously approved medications. Current management strategies follow the four D's paradigm of drugs, dietary elimination, dilation, and disease anxiety and hypervigilance therapy. On 20 May 2022, dupilumab was approved by FDA for EE. A dose of 300 mg dupilumab weekly significantly improved signs and symptoms of EE compared to placebo in a phase 3 trial. The approval of dupilumab will fulfill an unmet need for the increasing number of patients with EE.

摘要

嗜酸性食管炎(EE)是一种慢性的、免疫介导或抗原介导的食管疾病。对于EE患者来说,由于此前没有获批的药物,治疗可能具有挑战性。目前的管理策略遵循药物、饮食排除、扩张以及疾病焦虑和过度警惕治疗的“四个D”范式。2022年5月20日,度普利尤单抗获美国食品药品监督管理局(FDA)批准用于治疗EE。在一项3期试验中,与安慰剂相比,每周一次300毫克度普利尤单抗的剂量显著改善了EE的体征和症状。度普利尤单抗的获批将满足越来越多EE患者未得到满足的需求。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7c35/9364827/69010b8f1278/nihms-1827370-f0001.jpg

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