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口服JAK抑制剂治疗的特应性皮炎患者的实验室监测的实践建议(2024)

制定者:
国外皮肤性病专家编写小组

2024年8月7日

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中英对照

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.

口服Janus激酶抑制剂(JAKi)是一类先进的靶向全身疗法,在治疗中重度特应性皮炎(AD)方面已经证明了有效性和安全性。与其他小分子药物一样,口服JAKi具有潜在的脱靶效应,包括实验室相关不良事件(ae)。口服JAKi的产品标签建议进行初步实验室评估,并在4-12周后进行随访,以监测潜在的变化,基于口服JAKi治疗适应症的临床试验证据,这些证据可能无法反映常规临床实践中常见的中重度AD患者群体。为了弥补这一空白,一个由8名具有口服JAKi治疗AD临床和研究经验的皮肤科医生组成的小组对中度至重度AD人群中与口服JAKi相关的关键实验室相关ae进行了有针对性的文献综述。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和实验室监测共识建议相关的最佳实践声明,并使用从0到100的李克特量表确定了一致性水平。关于评估和监测关键实验室参数以及根据实验室变化而减少剂量或切换剂量的四项建议中的三项已取得高度一致;对正在进行的实验室监测频率的一致程度较低。在治疗AD时,适当的患者选择和实验室评估是减轻口服JAKi相关潜在风险的重要策略。

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口服JAK抑制剂治疗的特应性皮炎患者的实验室监测的实践建议(2024)
发布时间:  2024年8月7日
制定者:  
国外皮肤性病专家编写小组

35人浏览

0收藏

0次下载

摘要

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.

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