Task force on “European Pilot Survey on Systemic Adverse Reactions due to Specific Allergen Immunotherapy in real life setting”Renamed: European Adverse Systemic reactions Survey in allergen specific Immunotherapy, EASSI
Coordinator: Moises Calderon
Start date: 2011
Finish date: 2014
Rationale for establishing a Task Force: At present there is no Pan-European report on adverse reactions (clinically relevant systemic reactions) due to the regular use of specific allergen immunotherapy (i.e. subcutaneous and sublingual immunotherapy) outside clinical trials in a real clinical setting. Therefore, the EAACI Immunotherapy Interest Group would like to set up a Task Force to conduct the first “Prospective European Pilot Survey on Adverse Reactions due to Allergen Immunotherapy” using a harmonised terminology according to MedDRA. The adequate record of clinically relevant systemic adverse reactions due to specific allergen immunotherapy will lead to improved communication between National Societies and the EAACI, as well as being prepared for future dialogue with European regulatory and decision making authorities.
Participants: Responsible person: Dr Moisés A. Calderón (EAACI IT IG Chair). Medical Team: Prof Albrecht Bufe, Dr Victoria Cardona (EAACI VP for Communication), Prof Pascal Demoly (EAACI VP for Education), Dr Desiree Larenas-Linnemann, Dr Oliver Pfaar (EAACI IT IG Chair Secretary), Prof Erkka Valovirta, Prof Margitta Worm.Expert Advisers: Prof Jean Bousquet (ARIA WHO Expert), Dr Ea Dige (EU Pharmacovigilance Expert), Prof Allan Linneberg (Epidemiology Expert), Prof Hans-Jørgen Malling (SIT Expert), Prof Giovanni Passalacqua (SIT Expert), Dr Stefan Vieths (Paul Ehrlich Institute).Survey Secretary: Dr Pilar Rico Survey Manager: Dr Pablo Rodriguez del Rio
Main objectives:1.- Describe the safety profile of immunotherapy, prospectively, in real life setting in Europe.
2.- Estimate the incidence of clinically relevant systemic adverse reactions due to immunotherapy.
3.- Determine the number of systemic, anaphylactic and life-threatening allergic reactions occurring per patient and per treatment-year.
4.- Implement the use of a harmonised MedDRA based terminology on systemic adverse reactions after immunotherapy.
5.- Spread new epidemiological knowledge about immunotherapy adverse reactions to patients and doctors.
6.- Create an EAACI network of allergists.
7.- Generate data to be presented at EAACI events.
8.- Integrate activities and use of resources with the EAACI Junior Members.
9.- Use all available EAACI communication resources.
10.- Provide a regular report on Adverse Reactions due to specific allergen immunotherapy to all members of the EAACI Immunotherapy Interest Group and National Allergy Societies in the EU
The project is divided in three phases:
Phase I: “Defining and Planning the Pilot Survey”
Phase II: “Pilot Survey on Adv Reactions due to SCIT and SLIT in Clinical Setting”
Phase III: “European Full Scale Survey”. This phase is will be performed in a future stage according to results obtained in the Pilot Survey
Outcomes and possible benefits to EAACI:1.- EAACI will be able to spread new epidemiological knowledge about immunotherapy adverse reactions to patients and doctors across Europe.
2.- Increase the EAACI profile in education and communication across Europe and its academy members.
3.- To have updated information on the safety profile of allergen specific immunotherapy
4.- This project will help to create an EAACI network of allergists who are interested in allergen specific immunotherapy, increasing their knowledge in the safety profile of this therapeutic intervention.