Mark G Kirchhof, Vimal H Prajapati, Melinda Gooderham, Chih-Ho Hong, Charles W Lynde, Catherine Maari, Irina Turchin, Kim A Papp
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引用次数: 0
摘要
口服 Janus 激酶抑制剂(JAKi)是一类先进的系统性靶向治疗药物,在治疗中重度特应性皮炎(AD)方面具有良好的疗效和安全性。与其他小分子药物一样,口服 JAKi 也有可能产生脱靶效应,包括与实验室相关的不良事件 (AE)。根据口服 JAKi 治疗适应症临床试验的证据,口服 JAKi 的产品标签建议进行初始实验室评估,并在 4-12 周后进行随访以监测潜在的变化,但这可能无法反映常规临床实践中常见的中重度 AD 患者群体。为了弥补这一不足,由八位具有口服 JAKi 治疗 AD 临床和研究经验的皮肤科专家组成的专家小组对文献进行了有针对性的回顾,重点关注与中重度 AD 患者口服 JAKi 相关的主要实验室相关 AEs。在综合证据和知情意见的基础上,提出了一套与基本护理标准相关的最佳实践声明和有关实验室监测的共识建议,并使用 0 到 100 的李克特量表确定了一致程度。在与关键实验室参数的评估和监测以及根据实验室变化减少或更换剂量有关的四项建议中,有三项建议的一致程度较高;而与持续实验室监测的频率有关的建议的一致程度较低。在治疗AD时,适当选择患者和进行实验室评估是降低口服JAKi相关潜在风险的重要策略。
Practical Recommendations on Laboratory Monitoring in Patients with Atopic Dermatitis on Oral JAK Inhibitors.
Oral Janus kinase inhibitors (JAKi), a class of advanced targeted systemic therapy, have demonstrated efficacy and safety in the treatment of moderate-to-severe atopic dermatitis (AD). Like other small molecules, oral JAKi have the potential for off-target effects including laboratory-related adverse events (AEs). Product labels for oral JAKi recommend an initial laboratory assessment and follow-up 4-12 weeks later to monitor for potential changes, based on evidence from clinical trials across therapeutic indications for oral JAKi, which may not reflect a population of moderate-to-severe AD patients typically seen in routine clinical practice. To address this gap, a panel of eight dermatologists with clinical and research experience with oral JAKi for the management of AD conducted a targeted review of the literature focused on key laboratory-related AEs associated with oral JAKi in the moderate-to-severe AD population. Based on the synthesis of evidence and informed opinion, a set of best practice statements related to fundamental standards of care and consensus recommendations on laboratory monitoring were suggested, and level of agreement was ascertained using a Likert scale from 0 to 100. There was a high level of agreement on three of the four suggested recommendations related to assessment and monitoring of key laboratory parameters and to dose reduction or switching in response to laboratory changes; there was a lower level of agreement related to the frequency of ongoing laboratory monitoring. Appropriate patient selection and laboratory assessment is an important strategy to mitigate the potential risks associated with oral JAKi when treating AD.
期刊介绍:
Dermatology and Therapy is an international, open access, peer-reviewed, rapid publication journal (peer review in 2 weeks, published 3–4 weeks from acceptance). The journal is dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of dermatological therapies. Studies relating to diagnosis, pharmacoeconomics, public health and epidemiology, quality of life, and patient care, management, and education are also encouraged.
Areas of focus include, but are not limited to all clinical aspects of dermatology, such as skin pharmacology; skin development and aging; prevention, diagnosis, and management of skin disorders and melanomas; research into dermal structures and pathology; and all areas of aesthetic dermatology, including skin maintenance, dermatological surgery, and lasers.
The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/case series, trial protocols, and short communications. Dermatology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an International and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of quality research, which may be considered of insufficient interest by other journals. The journal appeals to a global audience and receives submissions from all over the world.