Multi-omics profiling of chronic immune-mediated skin diseases: SKINERGY protocol and strategic evaluation

IF 9.2 2区 医学 Q1 DERMATOLOGY
N. G. Koster, J. M. P. A. van den Reek, E. M. G. J. de Jong, S. van Beugen, A. I. M. van Laarhoven, I. Haeck, M. de Bruin-Weller, M. L. Schuttelaar, B. Horvath, A. Gostyński, A. Knulst, M. H. Vermeer, L. Nguyen, L. Gerbens, P. Spuls, M. A. Middelkamp-Hup, V. Exadaktylos, T. Niemeyer-van der Kolk, A. R. Schrader, A. M. Sluijmers, J. Versteeg, B. W. M. Arents, I. van Ee, J. L. A. G. van der Zon, M. de Leeuw, T. de Leeuw, P. van den Broek, C. Berkhof, D. Vellinga, S. Weidinger, S. Dubrac, Y. Li, M. van Steensel, M. Marchetti-Deschmann, M. Maurer, H. van der Zee, J. Damman, D. J. Hijnen, F. Wijk, M. M. B. Seyger, H. Röckmann, D. M. W. Balak, M. B. A. van Doorn, R. Rissmann, The Next Generation ImmunoDermatology (NGID) consortium
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引用次数: 0

Abstract

Background

The Dutch flagship project Next Generation ImmunoDermatology (NGID) aims to profile five chronic immune-mediated inflammatory skin diseases: atopic dermatitis (AD), plaque psoriasis (PSO), hidradenitis suppurativa (HS), chronic spontaneous urticaria (CSU) and cutaneous lupus erythematosus (CLE) in comparison with cutaneous T-cell lymphoma subtype mycosis fungoides (MF) and healthy volunteers. Within NGID, a clinical study entitled: ‘SKIN disease profiling by an Exploratory, pRospective, biomarker study in dermatoloGY practice (SKINERGY)’ will be conducted as a multicentre, parallel-cohort, open-label, observational, longitudinal basket study.

Objectives

Objectives include evaluation of disease-related characteristics in comparison to those of healthy volunteers and evaluation of biomarkers for disease stratification and (targeted) treatment response in patients in a real-world clinical setting. Additionally, differences and similarities in disease characteristics between diseases, changes over time, and profiles of responders versus non-responders will be evaluated.

Methods

Patients with AD (N = 120), PSO (N = 160), HS (N = 80), CSU (N = 120) and CLE (N = 120) will be enrolled in groups of N ≤ 40 patients per treatment. Matched healthy volunteers (N = 120) and the MF cohort (N = 120) will serve as control groups. Assessments include blood sampling, skin punch biopsies, tape stripping, skin swabs, (multimodal) imaging, tele-health and patient- and physician-reported outcomes. This manuscript describes the study protocol prior to data collection and its strategic evaluation of multi-omics profiling. Patient advocacy groups co-defined the research agenda and contributed to study design and informed consent document development, ensuring alignment with patients' needs and real-world relevance.

Results

SKINERGY will generate a machine learning-ready dataset with information about changes in various biomarkers over time, including histology, metabolomics, spatial proteomics, transcriptomics, lipidomics, microbiomics, imaging biomarkers, tele-health, patient-reported outcome measures (PROMs) and clinical parameters.

Conclusions

Identified biomarker profiles within SKINERGY may guide targeted treatment selection, enhance targeted therapeutic response in clinical practice and improve understanding of disease pathology in chronic immune-mediated skin diseases.

慢性免疫介导的皮肤病的多组学分析:SKINERGY方案和战略评估。
背景:荷兰旗舰项目下一代免疫皮肤病学(NGID)旨在分析五种慢性免疫介导的炎症性皮肤病:特应性皮炎(AD)、斑块性银屑病(PSO)、化脓性汗腺炎(HS)、慢性自发性荨麻疹(CSU)和皮肤红斑狼疮(CLE),并与皮肤t细胞淋巴瘤亚型真菌样真菌病(MF)和健康志愿者进行比较。在NGID范围内,一项名为“皮肤病学实践中一项探索性、前瞻性、生物标志物研究(SKINERGY)的皮肤病分析”的临床研究将作为一项多中心、平行队列、开放标签、观察性、纵向篮子研究进行。目的:目的包括评估与健康志愿者相比的疾病相关特征,以及评估现实世界临床环境中患者疾病分层和(靶向)治疗反应的生物标志物。此外,将评估疾病之间疾病特征的异同、随时间的变化以及反应者与无反应者的概况。方法:将AD (N = 120)、PSO (N = 160)、HS (N = 80)、CSU (N = 120)和CLE (N = 120)患者分为每次治疗N≤40例的组。配对的健康志愿者(N = 120)和MF队列(N = 120)作为对照组。评估包括血液取样、皮肤穿刺活检、胶带剥离、皮肤拭子、(多模式)成像、远程保健以及患者和医生报告的结果。本文描述了数据收集之前的研究方案及其多组学分析的战略评估。患者权益团体共同定义了研究议程,并为研究设计和知情同意文件的制定做出了贡献,确保与患者的需求和现实世界的相关性保持一致。结果:SKINERGY将生成一个机器学习就绪的数据集,其中包含各种生物标志物随时间变化的信息,包括组织学、代谢组学、空间蛋白质组学、转录组学、脂质组学、微生物组学、成像生物标志物、远程医疗、患者报告的结果测量(PROMs)和临床参数。结论:在SKINERGY中识别的生物标志物谱可以指导靶向治疗的选择,增强临床实践中的靶向治疗反应,提高对慢性免疫介导的皮肤病的疾病病理的理解。
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来源期刊
CiteScore
10.70
自引率
8.70%
发文量
874
审稿时长
3-6 weeks
期刊介绍: The Journal of the European Academy of Dermatology and Venereology (JEADV) is a publication that focuses on dermatology and venereology. It covers various topics within these fields, including both clinical and basic science subjects. The journal publishes articles in different formats, such as editorials, review articles, practice articles, original papers, short reports, letters to the editor, features, and announcements from the European Academy of Dermatology and Venereology (EADV). The journal covers a wide range of keywords, including allergy, cancer, clinical medicine, cytokines, dermatology, drug reactions, hair disease, laser therapy, nail disease, oncology, skin cancer, skin disease, therapeutics, tumors, virus infections, and venereology. The JEADV is indexed and abstracted by various databases and resources, including Abstracts on Hygiene & Communicable Diseases, Academic Search, AgBiotech News & Information, Botanical Pesticides, CAB Abstracts®, Embase, Global Health, InfoTrac, Ingenta Select, MEDLINE/PubMed, Science Citation Index Expanded, and others.
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