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阿布昔替尼:一种新的美国食品药品监督管理局批准的用于中重度特应性皮炎的药物。

Abrocitinib: A New FDA-Approved Drug for Moderate-to-Severe Atopic Dermatitis.

机构信息

Department of Dermatology, Center for Dermatology Research, Wake Forest School of Medicine, Winston-Salem, NC, USA.

Department of Pathology, Wake Forest School of Medicine, Winston-Salem, NC, USA.

出版信息

Ann Pharmacother. 2023 Jan;57(1):86-98. doi: 10.1177/10600280221096713. Epub 2022 May 19.

Abstract

OBJECTIVE

The objective of this article is to review abrocitinib, an oral Janus kinase (JAK) 1 inhibitor, for the treatment of patients with moderate-to-severe atopic dermatitis (AD).

DATA SOURCES

A literature search of MEDLINE (PubMed) was performed for articles from inception through end-March 2022 using the following search terms: atopic dermatitis, abrocitinib, PF-04965842, methotrexate, cyclosporine, dupilumab, ruxolitinib, and JAK-STAT pathway.

STUDY SELECTION AND DATA EXTRACTION

English articles relating to pharmacology, pharmacokinetics, efficacy, and safety of abrocitinib, and other conventional systemic medications for AD, were included.

DATA SYNTHESIS

Across phase IIb and phase III clinical trials, abrocitinib was efficacious with an average of 47.5% patients on 200 mg abrocitinib and 32.0% on 100 mg abrocitinib achieving an Investigator's Global Assessment (IGA) of 0 or 1 at 12 weeks. In comparison with dupilumab 300 mg subcutaneously every other week, patients on abrocitinib 200 mg once daily had improved disease severity and itch response. The majority of adverse events were not severe and self-limited.

RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE

Prior to Food and Drug Administration (FDA) approval of abrocitinib, prednisone was the only FDA-approved oral medication for AD. Although biologics such as dupilumab have revolutionized care, some patients prefer oral medications. Compared with clinical trials of conventional AD treatments, abrocitinib appears more effective.

CONCLUSIONS

Abrocitinib is an efficacious oral JAK 1 inhibitor recently FDA-approved for patients ≥ 18 years old with moderate-to-severe AD who have not responded to systemic medications or when contraindicated otherwise.

摘要

目的

本文旨在回顾阿布昔替尼,一种口服 Janus 激酶(JAK)1 抑制剂,用于治疗中重度特应性皮炎(AD)患者。

资料来源

通过使用以下搜索词,对 MEDLINE(PubMed)进行了文献检索,检索时间为 2022 年 3 月底:特应性皮炎、阿布昔替尼、PF-04965842、甲氨蝶呤、环孢素、度普利尤单抗、鲁索替尼、JAK-STAT 通路。

研究选择和数据提取

纳入了与阿布昔替尼的药理学、药代动力学、疗效和安全性以及 AD 的其他常规全身药物相关的英语文章。

数据综合

在 IIb 期和 III 期临床试验中,阿布昔替尼具有疗效,200mg 阿布昔替尼组和 100mg 阿布昔替尼组的平均有 47.5%和 32.0%患者在 12 周时达到研究者全球评估(IGA)0 或 1。与每两周皮下注射 300mg 度普利尤单抗相比,每天服用阿布昔替尼 200mg 的患者疾病严重程度和瘙痒反应得到改善。大多数不良事件不严重且为自限性。

对患者护理和临床实践的重要性

在阿布昔替尼获得美国食品和药物管理局(FDA)批准之前,泼尼松是唯一获得 FDA 批准的 AD 口服药物。尽管像度普利尤单抗这样的生物制剂改变了治疗方法,但有些患者更喜欢口服药物。与 AD 常规治疗的临床试验相比,阿布昔替尼似乎更有效。

结论

阿布昔替尼是一种有效的口服 JAK1 抑制剂,最近获得 FDA 批准,用于治疗对全身药物治疗无反应或存在禁忌证的 18 岁及以上中重度 AD 患者。

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