Atopic Dermatitis
Conditions
Keywords
Atopic dermatitis, Dupilumab, Dupixent, BioDay, Daily practice, Real world, Atopic Diseases Registry, Registry, Multi center, Biologics, Janus kinase inhibitors, Baricitinib, Upadacitinib, Abrocitinib, Tralokinumab
Brief summary
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.
Interventions
None listed
Sponsors
Academisch Ziekenhuis Groningen
Sanofi
AbbVie
Eli Lilly and Company
LEO Pharma
UMC Utrecht
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
0 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of effectiveness | Change from baseline to previous specified timepoints (16 weeks, 1 year, 2 year etc.) | 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. |
| 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. | To study drug survival and identify factors that affect drug survival. |
| Side effects | Change from baseline to previous specified timepoints (16 weeks, 1 year, 2 year etc.) | To register objective and subjective side effects and to identify potential risk factors. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Long-term safety | Yearly from baseline up to 5 years | To study the long-term safety risks including malignancies, pregnancy/paternity-related conditions, infections, and autoimmune diseases. |
| Characterization of population | Yearly from baseline up to 5 years | To characterize patient populations treated with new AD treatments in daily practice. |
| Dose tapering | Yearly from baseline up to 5 years | To assess whether dose reduction of biologics can be achieved in patients with low AD activity. |
| Comorbidities | Yearly from baseline up to 5 years | 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). |
| Characterization of side effects | Yearly from baseline up to 5 years | To collect data from daily practice regarding side effects (incidence, severity, risk factors, treatment options, etc.). |
| Laboratory monitoring | Yearly from baseline up to 5 years | 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). |
Countries
Netherlands
Contacts
Primary ContactMarlies de Graaf, MD, PhD
Backup ContactIlona de Ridder
Outcome results
None listed