Multi-omics profiling of chronic immune-mediated skin diseases: SKINERGY protocol and strategic evaluation.
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Koster N G, van den Reek J M P A, de Jong E M G J, van Beugen S, van Laarhoven A I M, Haeck I, de Bruin-Weller M, Schuttelaar M L, Horvath B, Gostyński A, Knulst A, Vermeer M H, Nguyen L, Gerbens L, Spuls P, Middelkamp-Hup M A, Exadaktylos V, Niemeyer-van der Kolk T, Schrader A R, Sluijmers A M, Versteeg J, Arents B W M, van Ee I, van der Zon J L A G, de Leeuw M, de Leeuw T, van den Broek P, Berkhof C, Vellinga D, Weidinger S, Dubrac S, Li Y, van Steensel M, Marchetti-Deschmann M, Maurer M, van der Zee H, Damman J, Hijnen D J, Wijk F, Seyger M M B, Röckmann H, Balak D M W, van Doorn M B A, Rissmann R, Next Generation ImmunoDermatology (NGID) consortium
Аннотация
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.