Biomarkers in Atopic Dermatitis and Psoriasis The Netherlands

Atopic dermatitis (AD) and psoriasis (Pso) are common inflammatory skin
disorders. They are heterogeneous diseases comprising a variety of subtypes,
which share common clinical characteristics but arise from distinct and
definable molecular and cellular mechanisms, i.e. endotypes, some of which
might overlap. Understanding these shared and exclusive mechanisms will lead to
the identification of biomarkers for patient stratification, and enable
reasonably accurate prediction of disease onset, progression and response to
therapy for appropriate selection of type and timing of intervention (decision
support) to reach a high degree of disease control (across patients and within
individuals).

BIOMAP (Biomarkers in Atopic Dermatitis and Psoriasis) NL is part of the BIOMAP
consortium, which is a EU-funded consortium through which various research
projects will address three main unmet needs in AD and Pso with a broad impact
on disease management, patient-directed care strategies and future trial
designs: (a) Identification of major determinants of manifestation, progression
and comorbidity development; (b) Improved understanding of shared and distinct
disease mechanism(s) and associated signatures, and their relative importance
in patient subpopulations; and (c) Identification of objective markers capable
of assessing disease-related individual patient trajectories and response to
different therapies. BIOMAP NL will only perform research in the field of
atopic dermatitis.

BIOMAP is a collaborative network of clinicians, researchers and industry along
with patient organisations and other major stakeholders. The BIOMAP project
has achieved the Consortium Agreement and Grant Agreement has been signed
(call: IMI2-2017-13-02: *Genome-Environment Interactions in Inflammatory Skin
Disease*). It will start on April 1st 2019. The Amsterdam UMC location AMC is
part of this consortium (BIOMAP NL) and will contribute patient data, biopsies,
blood samples and tape strips of AD patients (not Pso) to the consortium. Data
and biosamples will be collected from AD patients participating in the TREAT NL
(TREatment of ATopic eczema, the Netherlands) registry. The TREAT NL registry
is a non-WMO registry (W18_097 # 18.123).

Patients will be asked permission for the collection of body material and can
indicate themselves which and how much body material they are willing to
donate. The body material will be collected following their usual appointment
in the hospital. It concerns the collection of blood (a maximum of 8 tubes of a
maximum of 9 ml blood, at a maximum of 5 sampling points). In patients
receiving systemic treatment this extra amount of blood will be obtained during
the regular blood collection. Secondly, patients of 16 years and older can
participate in the collection of skin biopsies. Under local anesthesia, a round
piece of skin of up to 4 mm in diameter is removed from a spot that is
cosmetically acceptable. A maximum of 2 skin biopsies (lesional and
non-lesional skin) will be taken at a maximum of two collection time points
(baseline and after 3 months of treatment). Thirdly, tape strips will be
collected. Tape stripping is a painless non-invasive method where round
stickers of 3.8 cm2 are applied to the skin for 10 seconds and then removed
from the skin. Per visit a maximum of 8 consecutive tape strips will be
collected from a spot with eczema and a maximum of 8 tape strips from a spot
without eczema, preferably at the location of the forearm, at a maximum of 5
sampling points.

Participation in the collection of body material may cause discomfort:
- Blood: the procedure is a standard venipuncture. Blood sampling can be
painful to a limited extent or cause a bruise afterwards. For patients on
systemic treatments blood collection will occur anyhow in the context of
standard care. Patients receiving phototherapy will be asked if they are
willing to donate blood.
- Skin biopsy: the injection for the anesthesia of the skin is a bit painful;
if desired, extra an-aesthesia of the skin by applying an anesthetic ointment
30-60 minutes prior to the biopsy can be possible. Collection of the biopsy
thereafter is pain-free. There is a small chance of a short-term bleeding. The
small round wound in the skin will generally heal to a discrete scar. In rare
cases, inflammation of the wound can occur and the scar becomes less attractive.
- Tape strips: after the sample collection the skin may temporarily be slightly
redder than normal.