Department of Dermatology, Center for Dermatology Research, Wake Forest School of Medicine, Winston-Salem, North Carolina.
University of North Carolina School of Medicine, Chapel Hill, North Carolina.
J Am Acad Dermatol. 2015 Sep;73(3):420-8.e1. doi: 10.1016/j.jaad.2015.06.004. Epub 2015 Jul 14.
Safety profiles of systemic biologic agents for the treatment of psoriasis and psoriatic arthritis (PsA) encompass a wide spectrum of adverse events. To date, no uniform evidence-based guidelines exist regarding screening and monitoring patients who are undergoing biologic therapy.
We sought to identify studies evaluating screening and monitoring tests in the treatment of psoriasis and PsA with systemic biologic agents, and to propose evidence-based practical guidelines.
The MEDLINE database was searched to identify data on risks associated with adalimumab, etanercept, infliximab, and ustekinumab. Articles were reviewed and graded according to methods developed by the US Preventative Services Task Force.
Evidence was strongest (grade B) for tuberculosis screening. Interferon-gamma release assay was preferable to tuberculin skin testing. Among known hepatitis B virus carriers, the evidence grade was C for monitoring liver function tests and viral load.
This study was limited by the lack of high-quality controlled trials evaluating screening and monitoring tests in patients treated with biologic agents.
Baseline tuberculosis testing remains the only screening test with strong evidence to support its practice. Other screening and monitoring tests commonly performed in patients who are taking biologic agents are supported only in certain clinical settings or lack evidence to support or recommend against their practice.
用于治疗银屑病和银屑病关节炎(PsA)的全身性生物制剂的安全性概况涵盖了广泛的不良反应。迄今为止,尚无关于对接受生物治疗的患者进行筛查和监测的统一循证指南。
我们旨在确定评估全身性生物制剂治疗银屑病和 PsA 时进行筛查和监测测试的研究,并提出循证实用指南。
检索 MEDLINE 数据库,以确定与阿达木单抗、依那西普、英夫利昔单抗和乌司奴单抗相关的风险数据。根据美国预防服务工作组制定的方法对文章进行了审查和分级。
结核病筛查的证据最强(B 级)。干扰素γ释放试验优于结核菌素皮肤试验。在已知乙型肝炎病毒携带者中,监测肝功能和病毒载量的证据等级为 C 级。
本研究受到缺乏高质量对照试验评估生物制剂治疗患者的筛查和监测试验的限制。
基线结核病检测仍然是唯一具有强有力证据支持其应用的筛查检测。在接受生物制剂治疗的患者中经常进行的其他筛查和监测测试仅在某些临床情况下得到支持,或者缺乏支持或不推荐其应用的证据。