Future of the Allergists and Allergen Specific Immunotherapy (FASIT) Meets EACCI

Abstract

The symposium provided a flavour of key presentations and issues discussed at the 2017 Future of the Allergists and Allergen Specific Immunotherapy (FASIT) workshop held in Hamburg, Germany. Prof Wahn explained that the FASIT meeting brought together basic scientists, clinicians, and practitioners to brainstorm issues around allergy. Prof Jutel considered FASIT presentations exploring how precision medicine can be used to select optimal patients for allergen immunotherapy (AIT). He outlined the role of phenotypes and endotypes, reviewed some biomarkers that are currently under validation, and considered the role of adjuvants. Prof Kleine-Tebbe considered a number of promising Phase II studies that have failed to be translated into successful Phase III studies. Factors influencing results, he said, include high placebo effects, natural variability of the environment, patient heterogeneity, and the use of different endpoints for Phase II and III trials. Prof Pfaar considered whether allergen exposure chambers (AEC) are at a stage to be used for Phase III (pivotal) trials in AIT. He provided an overview of the history and advantages behind these facilities and reported the regulatory view. Prof Pfaar reported a recently published Position Paper from the European Academy of Allergy and Clinical Immunology (EAACI) addressing the current status of allergen chambers and setting the ‘frame’ for further developments, such as clinical validation. The position paper included the views of all relevant stakeholders, including clinicians, chamber operators, and regulators. In the second part of his talk, Prof Pfaar reviewed the introduction of paediatric investigation plans (PIP), which are required for allergen products prior to receiving marketing authorisation and considered the methodological problems for fulfilling these regulatory demands. Finally, Prof Pfaar called for further consultation and collaboration between all parties involved in AIT regarding possible improvement of PIP. Prof Kuna highlighted the European Union (EU) Directive 2001/83EC, which threatens both allergy diagnostics and the entire discipline of allergology. The directive states that allergens should be considered as drugs, and makes no distinction between allergens used for therapeutic procedures and those used for diagnostic purposes. The cost of obtaining and keeping marketing authorisations for test allergens is expensive. Already there are signs that allergen testing has been reduced in Europe. Prof Kuna concluded that it is essential for all stakeholders (authorities, allergists’ societies like the EAACI, the European Medicines Agency (EMA), European legislators, and allergen manufacturers) to come together to ensure the continued availability of in vivo allergen diagnostic tests in the EU.