The BioDay Registry aims to address the need for daily practice data regarding the effectiveness and safety of new systemic treatment options (like biologics and Janus kinase inhibitors) in patients with atopic dermatitis and effect on other atopic comorbidities in a multicenter setting. The registry already consists of several additional modules concerning atopic comorbidities, like food allergy and asthma, and a module for conjunctivitis during biologic treatment.
Study Type
OBSERVATIONAL
Enrollment
1,200
Radboud University Medical Center
Nijmegen, Gelderland, Netherlands
RECRUITINGIsala Dermatologisch Centrum
Zwolle, Overijssel, Netherlands
RECRUITINGMedisch Centrum Leeuwarden
Leeuwarden, Provincie Friesland, Netherlands
RECRUITINGUniversity Medical Center Groningen
Groningen, Provincie Groningen, Netherlands
RECRUITINGIJsselland Ziekenhuis
Capelle aan den IJssel, South Holland, Netherlands
RECRUITINGUniversity Medical Center Utrecht
Utrecht, Utrecht, Netherlands
RECRUITINGMeander Medisch Centrum
Amersfoort, Netherlands
RECRUITINGReinier de Graaf ziekenhuis
Delft, Netherlands
RECRUITINGCatharina ziekenhuis
Eindhoven, Netherlands
RECRUITINGSpaarne Gasthuis
Haarlem, Netherlands
RECRUITING...and 4 more locations
Assessment of effectiveness
To assess the effectiveness of new treatments in adult and pediatric patients with AD using physician measured clinical eczema scores as well as patient-reported outcome measures.
Time frame: Change from baseline to previous specified timepoints (16 weeks, 1 year, 2 year etc.)
Drug survival
To study drug survival and identify factors that affect drug survival.
Time frame: Drug survival analysis, which is the length of time a patient continues to take a particular drug, will be performed every year, with cumulative results over the years.
Side effects
To register objective and subjective side effects and to identify potential risk factors.
Time frame: Change from baseline to previous specified timepoints (16 weeks, 1 year, 2 year etc.)
Characterization of population
To characterize patient populations treated with new AD treatments in daily practice.
Time frame: Yearly from baseline up to 5 years
Characterization of side effects
To collect data from daily practice regarding side effects (incidence, severity, risk factors, treatment options, etc.).
Time frame: Yearly from baseline up to 5 years
Laboratory monitoring
To study the usefulness of laboratory monitoring during treatment in daily practice, with emphasis on subpopulations (e.g. elderly patients, patients with pre-existing liver and/or renal disease).
Time frame: Yearly from baseline up to 5 years
Long-term safety
To study the long-term safety risks including malignancies, pregnancy/paternity-related conditions, infections, and autoimmune diseases.
Time frame: Yearly from baseline up to 5 years
Comorbidities
To prospectively collect data from daily practice regarding the effect of new treatment options for AD on comorbidities (for example atopic diseases like asthma, food allergy and rhinoconjunctivitis can improve from these new drugs as many target the Th2 axis).
Time frame: Yearly from baseline up to 5 years
Dose tapering
To assess whether dose reduction of biologics can be achieved in patients with low AD activity.
Time frame: Yearly from baseline up to 5 years
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