(40213) TF Immunotherapy Adverse Events Registry (ADER)
Rationale for establishing a Task Force / Project:
Allergen Immunotherapy is a major treatment modality against a variety of allergic diseases; it is also the only treatment that holds promise for cure of allergy, by affecting the natural course of the disease. Although a large number of studies have proven both the efficacy and safety of both subcutaneous and sublingual immunotherapy, the extent of immunotherapy adverse events in real life has not been thoroughly recorded.
Such monitoring may give robust evidence of safety as well as reveal risk factors and variations. In the last few years, several arguments in favor of ‘real life’ studies, in different forms, have been raised and their value highlighted: real-life or effectiveness studies, include the whole width of a target population and incorporate patient preferences, compliance and other factors that are excluded in randomized trials or efficacy studies. Patient, disease and treatment registries have become increasingly recognized as important tools to improve standards of clinical care. While a number of medical specialties developed disease and treatment registries years back, for instance for diabetes and cardiovascular disease, there is still a lack of such registries within the allergy field.
The development of an Allergen Immunotherapy Adverse Events Registry (ADER), which can be used for pharmacovigilance, piloted in the Balkan area and subsequently expanded all over Europe.
The registry is web-based using the REDCap platform to ensure safe uploading of the data. Centers from eight countries (Albania, Bulgaria, Croatia, Greece, Romania, Serbia, Slovenia and Turkey) comprise, up to now, the consortium and more than 35 centers have already uploaded more than 2,500 records. The first publication is expected in 2017.
TF Steering Committee
Prof. N.Papadopoulos, Prof. T.Popov, Prof. M.Calderon
Last updated 29 June 2017