Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Academisch Ziekenhuis Groningen | OTHER |
| Sanofi | INDUSTRY |
| AbbVie | INDUSTRY |
| Eli Lilly and Company |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| 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.) |
| 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.). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
All adult and paediatric patients treated with new systemic treatments for AD will be asked for participation in the BioDay Registry
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marlies de Graaf, MD, PhD | Contact | +31887571134 | M.deGraaf-10@umcutrecht.nl | |
| Ilona de Ridder | Contact | L.H.deRidder-2@umcutrecht.nl |
| Name | Affiliation | Role |
|---|---|---|
| Marjolein de Bruin-Weller, Md, PhD | UMC Utrecht | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboud University Medical Center | Recruiting | Nijmegen | Gelderland | 6525 GA | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38272373 | Derived | Clabbers J, Boesjes C, Spekhorst L, van Gisbergen MW, Maas E, Marshall J, Janssen R, Janssen M, Zuithoff N, Steijlen P, de Graaf M, van Geel M, de Bruin-Weller M, Gostynski A. Influence of pathogenic filaggrin variants on dupilumab treatment in atopic dermatitis. J Allergy Clin Immunol. 2024 Apr;153(4):1155-1161.e4. doi: 10.1016/j.jaci.2023.12.027. Epub 2024 Jan 23. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| INDUSTRY |
| LEO Pharma | INDUSTRY |
Not provided
Not provided
Not provided
| 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 |
| Isala Dermatologisch Centrum | Recruiting | Zwolle | Overijssel | Netherlands |
|
| Medisch Centrum Leeuwarden | Recruiting | Leeuwarden | Provincie Friesland | Netherlands |
|
| University Medical Center Groningen | Recruiting | Groningen | Provincie Groningen | 9713 GZ | Netherlands |
|
| IJsselland Ziekenhuis | Recruiting | Capelle aan den IJssel | South Holland | Netherlands |
|
| University Medical Center Utrecht | Recruiting | Utrecht | Utrecht | 3584 CX | Netherlands |
|
| Meander Medisch Centrum | Recruiting | Amersfoort | Netherlands |
|
| Reinier de Graaf ziekenhuis | Recruiting | Delft | Netherlands |
|
| Catharina ziekenhuis | Recruiting | Eindhoven | Netherlands |
|
| Spaarne Gasthuis | Recruiting | Haarlem | Netherlands |
|
| Maastricht Univeristy Medical Center | Recruiting | Maastricht | Netherlands |
|
| Haga ziekenhuis | Recruiting | The Hague | Netherlands |
|
| Diakonessenhuis | Recruiting | Utrecht | Netherlands |
|
| St Antonius ziekenhuis | Recruiting | Utrecht | Netherlands |
|
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided