BioDay Registry: Data Collection Regarding the Use of New Systemic Treatment Options in Patients With Atopic Dermatitis

Study Overview
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Brief Summary
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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.

Official Title
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BioDay Registry: Prospective, Observational Data Collection Regarding the Use of New Systemic Treatment Options in Patients With Atopic Diseases in Daily Practice

Conditions
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Atopic Dermatitis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All adult and paediatric patients treated with new systemic treatments for AD will be asked for participation in the BioDay Registry Exclusion Criteria: Patients are not eligible for enrolment in case of presumed inability to answer questionnaires or not willing to answer questionnaires and will be excluded.

Ages Eligible for Study
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Minimum Age: 0 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | Change from baseline to previous specified timepoints (16 weeks, 1 year, 2 year etc.) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterization of population | To characterize patient populations treated with new AD treatments in daily practice. | 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.). | 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). | 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. | 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). | 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. | Yearly from baseline up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dupilumab, Atopic dermatitis, Dupixent, BioDay, Daily practice, Real world, Atopic Diseases Registry, Registry, Multi center, Biologics, Janus kinase inhibitors, Baricitinib, Upadacitinib, Abrocitinib, Tralokinumab