Better control and treatment of Atopic Dermatitis disease by exploring the universe of microenvironment imposed tissue signatures and their correlates in liquid biopsies

Immune-mediated diseases are extremely diverse - patients with the same
diagnosis may see the disease progress in very different ways, and respond
differently to treatments. This is because the course of the disease is
influenced by multiple factors, including the patient*s genes, immune system,
environment, and the microbes living in their gut. Furthermore, all of these
factors interact with and impact on one another. As a result, it is very hard
to predict how the disease will develop in a specific patient, and which
treatments will be effective.

The goal of the ImmUniverse WP 6 AD study is to add to our understanding of the
immune-mediated disease atopic dermatitis (which affects the skin). It will use
liquid biopsies to detect the immune cells circulating in the blood, and
analyze how these interact with the tissues affected at the microenvironment
scale.

The project*s findings should contribute to a better, more precise diagnosis
for patients; and better information on how severe the disease is likely to be
for each individual patient and how it will progress over time. Finally, the
project will make it easier for doctors and patients to monitor how well a
treatment is working in the future.

To collect prospective clinical and molecular data on the phenotypical
characteristics of patients with atopic dermatitis (AD) receiving standard care
targeted systemic treatment.

This is an open label, non-blinded, prospective study in which targeted
therapies are administered as part of standard healthcare and which aims at
identifying prognostic and therapeutic biomarkers associated with disease
activity, progression and response to therapy.

This is an observational trial in which licensed and available therapies are
used as per label. Patient eligibility is according to standard of care as laid
down in the SmPC. A key inclusion criterion is the prescription of a targeted
therapy (i.e. kinase inhibitor or biologic). Choice of medications (which are
all approved for first line use) is by treating physicians. It may be random
but is not randomized. Most of the follow-up procedures are according to
standards of care. Except for the biosampling at three timepoints during this
study. Standardized routine visits are performed to document patient
characteristics as well as physician- and patient-reported outcomes.

The patients will be recruited in a long-term follow up scheme, which comprises
an at least 12 month follow up for disease activity (PRO, biopsy, inflammation
markers etc. as outlined above) and where possible a further 24 month follow up
for assessment of disease course and complications (patient interview).
Baseline and follow up visits will include biopsy procedures and blood samples.

In general, we expect the risks for participation to be negligible. Skin
biopsies pose a small risk of (excessive) post biopsy bleeding, infection of
the biopsy wound and scar formation. However, despite being performed on large
scale in daily dermatology practice, severe complications are hardly ever
encountered. Post biopsy bleeding is prevented by applying adequate pressure to
the biopsy wound after the skin sample is taken. Infection prevention includes
the use of packed sterilized punch biopsy devices and disinfection of the body
site with alcohol before the biopsy is taken. Patients with a tendency to
develop hypertrophic scars will be excluded to prevent excessive scarring.

The extra vials of blood will be drawn from the patients at moments when blood
is already drawn for usual care.