The Spanish Registry of Systemic therapy in atopic eczema, BIOBADATOP, assesses drug safety and treatment effectiveness as well as treatment impact on quality of life in children and adults with atopic eczema receiving systemic immuno-modulatory therapies in Spanish daily practice.
The main objectives are:
1. To assess short and long-term safety of systemic therapies (including phototherapy) for atopic eczema (pharmacovigilance). 2. To assess short and long-term effectiveness of systemic therapies, providing a basis for shared decision making and guidelines.
Secondary objectives are:
1. To assess short and long-term safety of topical therapies for atopic eczema. 2. To assess effectiveness of different methods of care, including patient training. 3. To describe atopic dermatitis comorbidities.
Paediatric and adult patients with atopic eczema who due to the severity of their disease and/or impact on quality of life are commencing on or switching to a specific systemic immuno-modulatory agent (e.g. CyA, AZA, MTX or new/biologic treatments) for the first time in their life (might have received others, but not this specific one).
Diagnosis of atopic eczema in keeping with the UK/Irish diagnostic criteria.
Willingness to comply with all study requirements.
Insufficient understanding of the study by the patient and/or parent/guardian.
Patients who are currently participating in a randomised clinical trial.
Intention to move to a different geographical area in a short-term (next 3 months).
The population intends to be representative of all atopic dermatitis patients treated with systemic drugs in dermatology clinics in Spain.
Cohort
Prospective
Ciclosporin
DrugAny systemic drug used for atopic dermatitis in clinical practice
Rates of adverse events
For each drug or drug type
Relative rate of adverse events
Compared to a standard drug ( such as cyclosporine). Crude and adjusted
Change in Eczema Area and Severity Index (EASI)
EASI is used to measure the extent (area) and severity of atopic eczema.The minimum EASI score is 0 and the maximum EASI score is 72. A higher score means more severe or extended disease.
Change in Patient Oriented Eczema Measure (POEM)
The Patient Oriented Eczema Measure (POEM) is a tool used for monitoring atopic eczema severity. It focuses on the illness as experienced by the patient. It ranges from 0 to 28, with higher scores meaning worse disease.
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