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阿达木单抗治疗中重度化脓性汗腺炎患者的长期安全性。

Long-term safety of adalimumab for patients with moderate-to-severe hidradenitis suppurativa.

机构信息

4th Department of Internal Medicine, Medical School, National and Kapodistrian University of Athens, Athens, Greece.

出版信息

Expert Opin Drug Saf. 2020 Apr;19(4):381-393. doi: 10.1080/14740338.2020.1734560. Epub 2020 Feb 28.

Abstract

: Hidradenitis suppurativa (HS) is a chronic debilitating inflammatory skin disorder that affects regions rich in apocrine glands. Although the etiology of HS is not clear, inflammatory cytokines, like tumor necrosis factor (TNF)-α, participate in pathogenesis. Adalimumab (ADA), a human IgG1 monoclonal antibody that selectively targets TNFα, is the only EMA/FDA-approved biologic agent available for the therapy of moderate-to-severe HS.: A comprehensive literature search was conducted to present existing studies with an emphasis on the safety profile of ADA for the treatment of moderate-to-severe HS. ADA is prescribed for more than 15 years for varied indications and has improved the therapeutic outcomes of many diseases. Clinical trials and real-life safety data from ADA administration in HS were presented, with particular attention to special populations, such as children, elderly, and pregnant women.: Existing data advise for limited safety concerns with long-term ADA treatment provided that patients are thoroughly screened for infections, latent tuberculosis, and history of malignancy before the start of treatment.

摘要

: 化脓性汗腺炎(HS)是一种影响富含顶泌汗腺区域的慢性使人虚弱的炎症性皮肤疾病。尽管 HS 的病因尚不清楚,但炎症细胞因子(如肿瘤坏死因子[TNF]-α)参与了发病机制。阿达木单抗(ADA)是一种人源 IgG1 单克隆抗体,可选择性靶向 TNFα,是唯一获得欧洲药品管理局/美国食品药品监督管理局批准用于治疗中重度 HS 的生物制剂。: 进行了全面的文献检索,重点介绍了 ADA 治疗中重度 HS 的安全性概况。ADA 已被用于治疗多种疾病超过 15 年,改善了许多疾病的治疗效果。本文介绍了 ADA 在 HS 中的临床试验和真实世界安全性数据,特别关注儿童、老年人和孕妇等特殊人群。: 现有数据表明,长期使用 ADA 治疗的安全性顾虑有限,但前提是在开始治疗前对患者进行彻底的感染、潜伏性结核病和恶性肿瘤病史筛查。

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