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阿达木单抗治疗儿童和青少年重度斑块状银屑病:安全性评价。

Adalimumab in children and adolescents with severe plaque psoriasis: a safety evaluation.

机构信息

Dermatology Unit, University of Rome "Tor Vergata", Rome, Italy.

出版信息

Expert Opin Drug Saf. 2020 Apr;19(4):433-438. doi: 10.1080/14740338.2020.1752659. Epub 2020 Apr 26.

Abstract

: Psoriasis is a chronic inflammatory systemic disease that affects 2% of the population and is associated with an important physical and physiological burden. About 0.5-2% of psoriatic cases onset during the pediatric age range, and often it's not diagnosed until adulthood. Adalimumab is an antitumor necrosis factor monoclonal antibody approved for use in children in 2008 and now it was used in several diseases in rheumatology, gastroenterology, and in dermatology.: The purpose of this article was to summarize what has been described in the literature so far, about safety in the use of adalimumab in pediatric psoriasis. The presented data was extrapolated from a literature review from PubMed searches (using words 'pediatric psoriasis,' 'adalimumab children,' 'adalimumab safety,' 'pediatric psoriasis treatment,' 'adalimumab clinical trial'), treatment guidelines, and reports from European and United States regulatory agencies.: Actually there are some biologic agents for the treatment of pediatric psoriasis, but the lack of safety data from controlled trials is evident. The safety data on the use of adalimumab in pediatric psoriasis was taken from long-term studies in the adult population. These studies confirm the data on the safety of the drug as it is also supported by several works on real-life.

摘要

银屑病是一种慢性炎症性全身性疾病,影响 2%的人口,与重要的身体和生理负担有关。约 0.5-2%的银屑病病例发生在儿童时期,通常直到成年后才被诊断出来。阿达木单抗是一种抗肿瘤坏死因子单克隆抗体,于 2008 年获准用于儿童,现在已用于风湿病学、胃肠病学和皮肤病学中的多种疾病。本文的目的是总结迄今为止文献中描述的关于阿达木单抗在儿童银屑病中使用的安全性。所提供的数据是从 PubMed 搜索(使用“儿童银屑病”、“阿达木单抗儿童”、“阿达木单抗安全性”、“儿童银屑病治疗”、“阿达木单抗临床试验”)、治疗指南和欧洲及美国监管机构报告中提取的。实际上,有一些生物制剂可用于治疗儿童银屑病,但缺乏对照试验的安全性数据是显而易见的。阿达木单抗在儿童银屑病中的使用安全性数据来自成人的长期研究。这些研究证实了药物安全性的数据,因为它也得到了一些真实世界研究的支持。

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