The BioDay registry is a prospective cohort study. This means that patients will be followed up over a certain period of time. Together with the patient, the treating doctor or nurse will draw up a treatment plan for the atopic dermatitis. If a patient is treated with a new medication, data will be collected on the use of this medication. Participation in the study will have no effect on the patient's treatment.
The BioDay registry is coordinated by the National Expert Centre for Constitutional Eczema at the University Medical Centre Utrecht (UMCU) and the Department of Dermatology at the University Medical Centre Groningen (UMCG). The BioDay registry also involves several other hospitals in the Netherlands.
Patients in the BioDay registry are followed for at least five years. They are treated for their atopic dermatitis at one of the participating centres. The treating physician assesses whether the patient is suitable for participation in the BioDay registry.
At each outpatient visit, the effect of the medication is evaluated by looking at the skin. Additionally, we will ask about side effects, health complaints, check various blood values and ask patients to complete a number of questionnaires. These questionnaires include questions about the impact of the atopic dermatitis and its treatment on daily life.
In addition, a number of sub-studies are in progress, which include the following areas of focus:
Biologicals
Dupilumab - since October 2017
Tralokinumab - since November 2021
Lebrikizumab - since December 2024
JAK inhibitors
Baricitinib - as of January 2021
Upadacitinib - as of October 2021
Abrocitinib - since March 2022
The BioDay study protocol has been approved by the Medical Ethics Committee of the University Medical Centre Utrecht and follows Good Clinical Practice guidelines. The BioDay registry is also registered with ClinicalTrials.gov. This is a database of clinical trials conducted worldwide. All participating patients are informed, both written and verbally, about what participating in the BioDay Registry means for them. If the patient chooses to participate, an informed consent form must be signed.
The collection of data in the registry will comply with all applicable confidentiality, privacy and data protection laws. At each participating hospital, consent is obtained from the local Medical Ethics Review Committee and/or Board of Directors according to the locally established policy.
The BioDay Registry is financially supported by Sanofi/Regeneron, Abbvie, Lilly and LEO Pharma. These are pharmaceutical companies that do not have any access to the personal data of the patients in the trial. As a result, they have no influence on the processing of the data and the preparation of the reports. However, the reports are presented to them.
Scientific publications resulting from data from the BioDay registry appear with some regularity.
Below is an overview of publications to date.
Download patient information about BioDay here
Download the patient leaflet about dupilumab here
Download the patient brochure about tralokinumab disposable syringe (NL) here.
Download the patient brochure about tralokinumab Adolescents (NL) here.
Downloadthe patient brochure about tralokinumab disposable syringe (Arabic) here.
Download here Patient leaflet tralokinumab (ENG)
Download the patient leaflet about lebrikizumab here
Download here Patientleaflet lebrikizumab(ENG)
