Table 15.
Requirements on future AIT trials (modified according to the ”PRACTALL“ consensus report (EAACI and AAAAI [193] as well as the current ARIA report [221])
| Development and implementation of clinical studies | – Standardization and validation of clinical endpoints (e.g., CSMS) in AIT studies to ensure future comparability of clinical documentation on differing preparations, including independently for children, adolescents and adults – Clear definition of the period during which data on clinical symptoms are recorded (standardized classification of the severity of measured pollen exposure) – Further validation and standardization of the use of allergen exposure chambers, in order that these can be used in AIT not only in phase-II AIT studies – More detailed investigation of underlying immunological mechanisms of AIT |
| Specific questions | –AIT in polysensitized patients – (Secondary) preventive effects, such as preventing allergic march and new sensitizations with which AIT preparations – Long-term effects of AIT (adults and children) – Recording and analyzing the safety of AIT in patients that receive AIT in the case of particular co-factors or (relative) contraindications – More data from non-interventional observational trials in order to better assess the efficacy of AIT under practical conditions – Direct comparison of different preparations [unmodified (native) versus chemically modified], treatment regimens and modes of administration in a direct head-to-head comparison |
| Patient selection for clinical studies | – Development of methods/biomarkers to select patients ideally suited for AIT on the basis of responder phenotypes – Phenotyping according to indication (allergic rhinitis, bronchial asthma and atopic dermatitis) |
| Measurement of allergen content in various extracts | – Standardization, validation and general acceptance of measuring methods to determine the (major) allergen content |
| Biomarkers | – Identification and validation of biomarkers as predictive factors for the success of AIT |
| Efficacy and safety of AIT at different ages | – More studies complying with up-to-date quality standards on clinical efficacy, immunological effects and safety stratified according to age (children, adults, >65 years) |
| New approaches in AIT | – Investigation and confirmation of the efficacy and safety of AIT by using new adjuvants, synthetically produced peptides, recombinants or modified therapy allergens as well as by means of new modes of allergen administration, such as intralymphatic or epicutaneous immunotherapy |
| Safety and tolerability of AIT | – Clear international definition of contraindications in AIT – Central register to record systemic reactions to AIT in everyday practice |
| Adherence | – Development of further programs to improve patient compliance |
| Socio-economics | – Long-term (>3 years) cost-effectiveness of AIT |