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.
Study Type
OBSERVATIONAL
Enrollment
2,500
Any systemic drug used for atopic dermatitis in clinical practice
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain
RECRUITINGHospital General Universitario de Alicante
Alicante, Spain
RECRUITINGHospital del Mar IMIM
Barcelona, Spain
RECRUITINGHospital Universitario de Gran Canaria Dr Negrín
Las Palmas, Spain
RECRUITINGHospital Infanta Leonor
Madrid, Spain
RECRUITINGHospital Universitario de la Princesa
Madrid, Spain
RECRUITINGComplexo Hospitalario Universitario de Pontevedra
Pontevedra, Spain
RECRUITINGHospital Universitario y Politécnico la Fe
Valencia, Spain
RECRUITINGHospital Miguel Servet
Zaragoza, Spain
RECRUITINGRates of adverse events
For each drug or drug type
Time frame: through study completion, an average of 3 years
Relative rate of adverse events
Compared to a standard drug ( such as cyclosporine). Crude and adjusted
Time frame: through study completion, an average of 3 years
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.
Time frame: Change between baseline and 6 months
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.
Time frame: Change between baseline and 6 months
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