Validation of Clinical endpoints in AIT (with MASK technology)
Validation of Clinical endpoints in AIT (with MASK technology)
In 2014, the EAACI has published a Task Force (TF) Position Paper on “clinical endpoints in AIT” and provided a definition for the primary endpoint in future AIT trials, a combined symptom and medication score (CSMS). This endpoint is increasingly used in current trials, but also needs further formal validation. Thea im of the Task Force is to provide a sound concept of further validation and to perform an analysis by the use of (MASK-air®) an App developed by an international network (Mobile Airways Sentinel NetworK)) categorized as Good Practice of DG Santé on digital tools for citizen empowerment and person-centred care for rhinitis and asthma multimorbidity.The TF comprised ofinternational experts in the field, clinicians, representatives from regulatory authorities and methodologists (#1). This PP has for the first time proposed a harmonized and standardized definition for the primary endpoint, a combined symptom and medication score (CSMS) in clinical trials in AIT. A formal validation of this endpoint is pending. MASK (Mobile Airways Sentinel NetworK) has been categorized as Good Practice of DG Santé on digital tools for citizen empowerment and person-centred care for rhinitis and asthma multimorbidity (#2). Beneath others, one main achievement of this network has been an App on rhinitis and asthma (MASK-air®), available in 23 countries, currently downloaded by more than 23.000 users and fully validated in between (#3). In 2021, our group reported the potential of mobile health technology in the field of AIT in general (#4). #1.Pfaar O, et al.(2014). Allergy2014;69(7):854- 867.#2. Bousquet J, et al. (2018). Clin Transl Allergy. 2019;9:16.#3. Bousquet J et al. (2018). Clin Transl Allergy.2018;8:45. #4. : Bousquet J*, Jutel M*, Pfaar O*, et al. The ARIA-EAACI perspective. J Allergy Clin Immunol Pract 2021. Besides we have validated the (modified) symptom and medications core (mCSMS) based on real world data data from more than 17.000 MASK air users confirming that this App is a valuable tool in assessing and controlling AIT (#5). #5. : Pfaar O, et al. Effects of allergen immunotherapy in the MASKair study: a proof-of-concept analysis. Allergy 2021: doi: 10.1111/all.14955
IG Allergen Immunotherapy
Chair: Oliver Pfaar
Secretary: Jean Bousquet