BUSAN, South Korea, Dec. 15, 2023 /PRNewswire/ -- Atopic dermatitis (or AD) is a heterogenous, inflammatory condition of the skin and is usually accompanied by itch, redness, and swelling. AD can have a significant impact on the patient's quality of life. While several biologic treatment approaches have been proposed in the recent years for the treatment of AD, they often fall short of providing the required care in relieving symptoms of moderate-to-severe AD..

韩国釜山，2023年12月15日/PRNewswire/--特应性皮炎（或AD）是一种异质性皮肤炎症，通常伴有瘙痒，发红和肿胀。AD可以对患者的生活质量产生重大影响。虽然近年来已经提出了几种生物治疗方法来治疗AD，但它们通常不能提供缓解中度至重度AD症状所需的护理。。

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The comprehensive safety analysis establishes evidence regarding the safety of systematic Janus kinase inhibitors in patients with atopic dermatitis.

综合安全性分析为特应性皮炎患者系统性Janus激酶抑制剂的安全性提供了证据。

In this context, Janus kinase (or JAK) inhibitors are small molecules that have emerged as a promising treatment option for managing AD. They act by blocking the JAK family kinases and inhibiting the inflammatory pathways involved in AD and other inflammatory diseases. Recently, ten JAK inhibitors have been approved by the US Food and Drug Administration (FDA) to treat diseases like rheumatoid arthritis, ankylosing spondylarthritis, COVID-19, and AD, among others.

在这种情况下，Janus激酶（或JAK）抑制剂是一种小分子，已成为治疗AD的有希望的治疗选择。它们通过阻断JAK家族激酶并抑制AD和其他炎症性疾病中涉及的炎症途径起作用。最近，美国食品和药物管理局（FDA）批准了十种JAK抑制剂，用于治疗类风湿性关节炎，强直性脊柱炎，COVID-19和AD等疾病。

However, the FDA has also issued a boxed warning for JAK inhibitors to include the risk of major adverse events. Since then, many meta-analyses focusing on the safety of JAK inhibitors have been published, but these analyses are fraught with several limitations. Further research is therefore needed to understand the safety profile of JAK inhibitors.

然而，FDA也对JAK抑制剂发出了盒装警告，包括重大不良事件的风险。从那时起，已经发表了许多关于JAK抑制剂安全性的荟萃分析，但这些分析充满了一些局限性。因此，需要进一步的研究来了解JAK抑制剂的安全性。

This can help in tailoring the therapeutic strategies of AD as per patient's needs, while also minimizing adverse effects and enhancing the effectiveness of JAK inhibitors..

这可以帮助根据患者的需求定制AD的治疗策略，同时还可以最大程度地减少不良反应并提高JAK抑制剂的有效性。。

To this end, a group of researchers from Pusan National University led by Associate Professor Yun Hak Kim, affiliated with the university's Department of Anatomy and Department of Biomedical Informatics, conducted an extensive analysis of randomized controlled trials (RCTs) involving JAK inhibitors in patients with AD.

为此，由釜山国立大学解剖学系和生物医学信息学系副教授Yun Hak Kim领导的一组研究人员对涉及JAK抑制剂的随机对照试验（RCT）进行了广泛分析。AD患者。

The systematic review and meta-analysis, published in the Journal of the European Academy of Dermatology & Venereology on 19 August 2023, examined whether the use of JAK inhibitors increased the occurrence of adverse events in patients with AD. They identified studies reporting the adverse events associated with JAK inhibitor use from Medline, Embase, Clinicaltrials.gov, among others for this study.

该系统评价和荟萃分析于2023年8月19日发表在《欧洲皮肤病与性病学会杂志》上，研究了JAK抑制剂的使用是否增加了AD患者不良事件的发生。他们确定了报告不良事件的研究，这些不良事件来自Medline，Embase，Clinicaltrials.gov，这项研究的其他研究。

They reviewed the available safety data and analyzed the risk of 11 adverse events from 14 RCTs published between 2019 and 2022..

他们审查了现有的安全性数据，并分析了2019年至2022年间发表的14项随机对照试验中11种不良事件的风险。。

Their analysis revealed that the relative risk of developing herpes zoster, headache, acne, elevated blood creatinine phosphokinase, and nausea increased among those patients with AD who received treatment with JAK inhibitors. However, the incidence of serious conditions did not increase significantly in JAK inhibitors-exposed patients with AD.

他们的分析显示，接受JAK抑制剂治疗的AD患者患带状疱疹，头痛，痤疮，血肌酐磷酸激酶升高和恶心的相对风险增加。然而，在JAK抑制剂暴露的AD患者中，严重疾病的发生率没有显着增加。

'The comprehensive safety analysis revealed that, contrary to concerns regarding malignancy, venous thromboembolism, and major adverse cardiac events, use of JAK inhibitors was not associated with a significant increase in the overall risk in patients with AD. Therefore, we believe that understanding and managing common adverse events is the need of the hour, particularly those like headache, acne, and nausea, among others,' explains Prof.

“综合安全性分析显示，与对恶性肿瘤，静脉血栓栓塞和主要不良心脏事件的担忧相反，使用JAK抑制剂与AD患者总体风险的显着增加无关。因此，我们认为了解和管理常见不良事件是一个小时的需要，特别是头痛，“痤疮、恶心等等，”教授解释道。

Kim.This analysis revealed a higher risk of acne in patients receiving upadacitinib and abrocitinib, and this increased in risk was dose-dependent. Moreover, higher dose of JAK inhibitors was correlated with an increased risk of acne and elevated blood pressure.  Overall, these findings underscore the importance of comprehending the safety of JAK inhibitors for informed decision-making and managing AD, with a particular emphasis on long-term observations of major cardiovascular events with typically prolonged courses.ReferenceTitle of original paper: The safety of systemic Janus kinase inhibitors in atopic dermatitis:A systematic review and meta-analysis of randomized controlled trialsJournal: Journal of the European Academy of Dermatology & VenereologyDOI: https://doi.org/10.1111/jdv.19426 About Pusan National UniversityWebsite: https://www.pusan.ac.kr/eng/Main.doMedia Contact:Jae-Eun Lee82 51 510 7928[email protected]SOURCE Pusan National University (PNU).

金姆。这项分析显示，接受upadacitinib和abrocitinib治疗的患者患痤疮的风险较高，这种风险增加是剂量依赖性的。此外，较高剂量的JAK抑制剂与痤疮风险增加和血压升高有关。总体而言，这些发现强调了了解JAK抑制剂的安全性对于知情决策和管理AD的重要性，特别强调了对主要心血管事件的长期观察，通常病程延长。参考文献原著标题：系统性Janus激酶抑制剂在特应性皮炎中的安全性：随机对照试验的系统评价和荟萃分析期刊：欧洲皮肤病与性病学会杂志：https://doi.org/10.1111/jdv.19426关于釜山国立大学网站：https://www.pusan.ac.kr/eng/main.domedia联系人：Jae Eun Lee82 51 10 7928[电子邮件保护]来源釜山国立大学（PNU）。