ongitudinal variation of blood based biomarkers in moderate-to-severe atopic dermatitis patients, a prospective cohort study

Conditions: atopic dermatitis
eczema
10014982

Registration Number: NL-OMON51834

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 260

Inclusion Criteria

- Adult patients with moderate-to-severe atopic dermatitis
- An intention to start cyclosporine A, dupilumab, tralokinumab, oral
JAK-inhibitor (abrocitinib or upadacitinib) treatment according to the NVDV
guideline
- Documented recent history (last 6 months) of eligibility for treatment with
immunosuppressants, biologicals and JAK-inhibitors.

Exclusion Criteria

- Children and adolescents (<18 years)
- men and women planning pregnancy during study, pregnant women and
breastfeeding women
- Patients with other inflammatory skin diseases, autoimmune diseases, or other
systemic
inflammatory diseases will be excluded (eg. psoriasis, diabetes mellitus,
inflammatory bowel
disease, rheumatoid arthrtitis).

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To investigate longitudinal variation of blood based biomarkers, their<br /><br>integration with disease severity, comorbidities, their association with<br /><br>standard care and characterization of adequate and inadequate responders to<br /><br>standard care in a longitudinal observational study in subjects with<br /><br>moderate-to-severe atopic dermatitis (AD).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Investigator*s Global Assessment (IGA)1 score at all visits.<br /><br>• Eczema Area and Severity Index (EASI)2 score at all visits.<br /><br>• At least 50% reduction in EASI score (EASI50; yes/no) at all visits.<br /><br>• Patient-Oriented Eczema Measure (POEM)3 score at all visits.<br /><br>• Dermatology Life Quality Index (DLQI)4 at all visits.<br /><br>• Numerical Rating Scale pruritus (NRS pruritus)5 score at all visits<br /><br>• Monitoring asthma and rhinitis disease activity and medication.</p><br>