The goal of this observational study is to comprehensively profile six immune-mediated inflammatory diseases, including atopic dermatitis (AD), plaque psoriasis (PSO), hidradenitis suppurativa (HS), cutaneous T-cell lymphoma subtype mycosis fungoides (MF), chronic spontaneous urticaria (CSU), and cutaneous lupus erythematosus (CLE) in daily practice. Data will be compared with data from healthy volunteers. This study is part of the larger NGID (Next Generation ImmunoDermatology) initiative, of which the main objective is to develop infrastructure that enables personalised patient care. The main questions the SKINERGY study aims to answer are:
* Which biomarkers can discriminate between responders and non-responders to treatment in patients with AD, CLE, CSU, HS, MF, and PSO? * How do disease-related biomarkers in patients with AD, CLE, CSU, HS, MF, and PSO differ from those in healthy volunteers? * Which (multi-omics) biomarkers are associated with disease subtypes and predict response or non-response to (targeted) therapies in daily clinical practice? * How do biomarker profiles compare across different cohorts of patients with immune-mediated inflammatory skin diseases (AD, CLE, CSU, HS, MF, PSO) * How do biomarker levels change over time in response to treatment in these patient populations? * Which skin tissue biomarkers are associated with disease progression or treatment response? * How do the genomic profiles of patients differ across diseases or correlate with treatment outcomes? * Can additional imaging biomarkers enhance the characterization of disease profiles or treatment monitoring over time?
Researchers will compare both differences beween patients within a disease group in different treatment arms, as well as patients within the same treatment arm. Additionally, biomarker profiles of patients with different diseases will be evaluated. These comparisons will be made to see if shared or distinct biomarker patterns exist across diseases and treatments, which could inform patient stratification, optimize therapeutic decision-making, and identify potential targets for future interventions.
Participants will start medication according to national guidelines for the treatment of their inflammatory skin disease (AD: Cyclosporin A, anti-IL4/13, or anti-JAK; PSO: anti-TNF, anti-IL23, ani-IL17, anti-TYK2; HS: anti-TNF, anti-IL17; MF: CHLORM, TSC, PUVA-UV-B; CSU: anti-IgE, Cyclosporin A, anti-BTK\*; CLE: TSC, HCQ, MTX)
\*once approved and reimbursed in the Netherlands
Participants will:
* Take the prescribed medication for their skin disease (in line with standard care in the Netherlands). * Visit the clinic for a study visit combined with their standard care appointment 3 times (baseline, month 3, and month 6. An additional 4th visit at month 12 is optional). * Fill in an online set of questionnaires from home, 3 times during the study period (an additional 4th time is optional). * Patients with CSU fill in the UAS7 (and if applicable the AAS7) daily for the study period.
Able to understand and provide a written informed consent prior to any study procedures
Male or non-pregnant female, ≥18 years of age
Patient is willing to refrain from extensively washing (including bathing, swimming) the target lesional skin 12 hours before every study visit day.
Patient is willing and able to comply with the study protocol
Have any other relevant skin infection/disease in the treatment area other than the investigated skin disease.
Subjects who have received treatment with any non-marketed drug substance (that is, an agent which has not yet been made available for clinical use following registration) within 4 weeks prior to the baseline visit.
1 week for topical treatment, e.g. corticosteroids, retinoids, vitamin D analogs, calcineurin inhibitors
4 weeks for phototherapy, e.g. UVB, PUVA, PDT
Patients with six different inflammatory skin diseases (AD, PSO, CLE, HS, CSU, and MF) will be enrolled. Each indication will include multiple treatment groups, with up to 40 patients per group. In total, approximately 120 patients per disease will be studied, except for PSO (4 treatment groups, N=160) and HS (2 treatment groups, N=80), covering a range of disease severities. Patients will be recruited from the local hospital where they receive standard care and will also attend study visits at this location. Healthy volunteers will be recruited through the Centre for Human Drug Research.
Cohort
Prospective
Not listed
18
Trial groupsSee each trial group below.
Lipidomics of the stratum corneum and OLINK
Tape stripping will be performed on (non-)lesional skin and healthy skin for extraction of lipids for analysis and analysis will be performed using OLINK.
Cutaneous microbiome
The microbiome is collected by swabbing. The abundance of bacteria is thereafter determined using next-generation sequencing.
Serum biomarkers
Blood serum will be collected and processed for subsequent biomarker extraction and analysis. The specific biomarkers to be assessed will be determined at a later stage, based on the results of preliminary pilot studies.
Plasma biomarkers
Blood plasma will be collected and processed for the extraction and analysis of biomarkers. The specific biomarkers to be assessed will be determined at a later stage, based on the results of preliminary pilot studies.
User experience and subjective burden questionnaire
Measures the user experience and subjective burden of the different assessments performed in this study.
Patient reported outcomes
Patients will be asked to report on the impact of their skin disease on different aspects of their lives, with the following questionnaires: DLQI, TSQM, HADS\< NRS pruritus and burning sensation/pain, 5-D itch scale, ISDL, ISBQ, PSWQ, ISDL, expectancies and avoidance behaviour, G-EEE, SQSQ-S, DS-14. The following questionnaires are optional: PSS, P-scale short, and SEMCD. The following disease specific patient reported outcomes are measured: RECAP, POEM, AAS7, UAS7, UCT, HiSQoL.
Skin barrier function by Electrical Impedance Spectroscopy (EIS)
The barrier status by trans epidermal water loss of (non-)lesional skin and healthy skin will be determined using EIS.
Line-Field Confocal Optical Coherence Tomography (LC-OCT)
LC-OCT is a non-invasive optical imaging technique based on a combination of the optical principles of optical coherence tomography and reflectance confocal microscopy with line-field illumination, which can generate cell-resolved images of the skin, in vivo, in vertical section, horizontal section and in three dimensions.
Click on the lead sponsor to view all of their trials.
Leiden University Medical Center
Lead sponsor
Erasmus Medical Center
Collaborator
Radboud University Medical Center
Collaborator
Amsterdam University Medical Center
Collaborator
UMC Utrecht
Collaborator
Maastricht University Medical Center
Collaborator
University Medical Center Groningen
Collaborator
Centre for Human Drug Research, Netherlands
Collaborator
