Identification of Biomarkers and Critical Evaluation of Biomarker Validation in Hidradenitis Suppurativa: A Systematic Review.
Identification of Biomarkers and Critical Evaluation of Biomarker Validation in Hidradenitis Suppurativa: A Systematic Review.
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DOI：
10.1001/jamadermatol.2021.4926
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发表时间：
2022-03-01
期刊：
影响因子：
10.9
通讯作者：
中科院分区：
文献类型：
--
作者：
化脓性汗腺炎(HS)生物标志物的识别和验证有可能改善对这一慢性负担疾病的理解和治疗。系统地识别所有已知的HS生物标记物，按生物标记物类型进行分类，并根据已建立的标准对其有效性进行批判性评估。本综述的资格标准(PROSPERO REGISTION 230830)包括随机临床试验、非对照临床试验、队列研究、病例对照研究和其他观察性研究，在2020年12月31日之前不受患者年龄、性别、种族或民族或发表语言的限制。所有文章都被归类为生物标记物类型，使用美国食品和药物管理局的生物标记物、终点和其他工具(最佳)词汇表进行定义。根据美国食品和药物管理局和欧洲药品管理局的建议生物标记物验证指南，对每个已识别的生物标记物进行了评估。使用推荐、评估、发展和评价(等级)方法对关于单个生物标记物的总体数据的强度进行评估。共筛选出3953篇无重复文章，其中1429篇根据纳入/排除标准进行检索。经过全文筛选和数据提取，纳入本综述的文献共106篇。使用分级标准评估6类生物标记物(敏感性/风险、诊断、监测、预测、预后和药效/反应生物标记物)的强度证据。总共确定了48个生物标志物，最低等级为中等。仅有1项诊断(血清IL-2R)、1项监测(皮肤多普勒血管)和2项预测生物标志物(上皮化隧道和HS家族史)达到高评级。已确定的生物标记物没有一个具有足够的临床有效性，可以推荐在临床环境中常规使用。在HS管理中识别、验证和引入常规生物标记物的主要障碍包括缺乏独立的生物标记物验证研究(特别是基于组学的无假设技术)；对已识别或建议的生物标记物之间的共线性评估不足；以及缺乏将生物标记物纳入临床试验结构的常规整合。研究人员、临床医生和制药利益相关者之间需要达成国际共识，以标准化目标和方法，并鼓励将生物标记物整合到未来的HS临床试验中。这一系统的综述为近期未来的研究提出了一些优先事项，以克服HS中生物标记物的这些障碍和限制。
The identification and validation of biomarkers in hidradenitis suppurativa (HS) has potential to improve the understanding and management of this chronic, burdensome disease. To systematically identify all known HS biomarkers, categorize them by biomarker type, and critically evaluate their validity according to established criteria. Eligibility criteria for this review (PROSPERO Registration 230830) included randomized clinical trials, uncontrolled clinical trials, cohort studies, case-control studies, and other observational studies with no restrictions of patient age, sex, race or ethnicity, or language of publication up until December 31, 2020. All articles were categorized into biomarker type, defined using the US Food and Drug Administration Biomarkers, Endpoints, and other Tools (BEST) glossary. Assessment of each identified biomarker was undertaken in line with the US Food and Drug Administration and European Medicines Agency guidelines for the validation of proposed biomarkers. Assessment of the strength of overall data regarding individual biomarkers was undertaken using the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) approach. A total of 3953 nonduplicate articles were screened, of which 1429 articles were retrieved based on the include/exclusion criteria applied. After full-text screen and data extraction, 106 articles were included in this review. The evidence of strength of 6 categories of biomarkers (susceptibility/risk, diagnostic, monitoring, predictive, prognostic, and pharmacodynamic/response biomarkers) was assessed using GRADE criteria. A total of 48 biomarkers were identified with a minimum GRADE rating of moderate. Only 1 diagnostic (serum IL-2R), 1 monitoring (dermal Doppler vascularity), and 2 predictive biomarkers (epithelialized tunnels and positive family history of HS) achieved a GRADE rating of high. None of the identified biomarkers had sufficient clinical validity to be recommended for routine use in the clinical setting. Major barriers to the identification, validation, and introduction of routine biomarkers in the management of HS include lack of independent biomarker validation studies (especially assumption-free “omics”-based techniques); insufficient assessment of collinearity between identified or proposed biomarkers; and a lack of routine integration of biomarkers into the structure of clinical trials. International consensus among researchers, clinicians, and pharmaceutical stakeholders is required to standardize goals and methods and encourage biomarker integration into future HS clinical trials. This systematic review presents a number of priorities for near-term future research to overcome such barriers and limitations of biomarkers in HS.
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影响因子：
6.5
作者：
Frew, John W.;Marzano, Angelo V.;Piguet, Vincent
通讯作者：
Piguet, Vincent
影响因子：
3.6
作者：
Eser, Emel;Engin, Burhan;Askin, Ozge
通讯作者：
Askin, Ozge
影响因子：
--
作者：
Frew JW;Jiang CS;Singh N;Navrazhina K;Vaughan R;Krueger JG
通讯作者：
Krueger JG
影响因子：
3.4
作者：
Batycka-Baran, Aleksandra;Baran, Wojciech;Szepietowski, Jacek Cezary
通讯作者：
Szepietowski, Jacek Cezary
DOI：
10.1111/jdv.14745
发表时间：
2018-08-01
影响因子：
9.2
作者：
Caro, R. D. Caposiena;Solivetti, F. M.;Bianchi, L.
通讯作者：
Bianchi, L.