BACKGROUND
Dupilumab is the first antibody based treatment for atopic dermatitis (AD). It is expected that many new treatment options become available for the treatment of atopic diseases in the near future. Despite the high quality of clinical trials, results are not always generalizable to daily practice.
OBJECTIVE
Registry based collection of real life data can add information that is not gained in clinical trials.
METHODS
The BioDay Registry prospectively collects real life treatment results regarding effectiveness and safety of patients treated with new systemic treatment options for AD in a multicenter setting. Effectiveness is assessed based on both physician measured clinical eczema scores as well as patient-reported outcome measures. Long-term safety risks are monitored. The possibility for dose reduction in patients with disease control can be investigated. The treatment effect on other atopic co-morbidities will be monitored. The BioDay Registry can be easily adjusted, and new modules on new treatment options can be added. As outcome measures are in line with the core outcomes for eczema recommended by the global Harmonising Outcome Measures for Eczema (HOME) initiative, it is possible to merge data with other registries in future.
RESULTS
The BioDay Registry was considered as non-interventional by the local Medical Ethics Committee and the collection of data is performed according to the Helsinki Declaration. Protocol amendments will always be submitted for review to the Medical Ethics Committee.
CONCLUSIONS
The BioDay Registry will provide unique prospectively collected data on the use of targeted therapies in daily practice for AD patients. The results of this registry will contribute to the development of more personalized treatment strategies for patients with moderate to severe AD.
CLINICALTRIAL
ClinicalTrials.gov identifier: NCT03549416, retrospectively registered June 8, 2018.
