This company-sponsored symposium took place on 20th June 2017 as part of the European Academy of Allergy and Clinical Immunology (EAACI) Congress in Helsinki, Finland
Chairpersons: Ulrich Wahn,1 Marek Jutel2
Speakers: Marek Jutel,2 Jörg Kleine-Tebbe,3 Oliver Pfaar,4,5 Piotr Kuna6
1. Charité – Universitätsmedizin Berlin, Berlin, Germany
2. Wrocław Medical University, Wrocław, Poland; ALL-MED Medical Research Institute, Wrocław, Poland
3. Allergy & Asthma-Center Westend, Berlin, Germany
4. Department of Otorhinolaryngology, Head and Neck Surgery, Universitätsmedizin Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany
5. Center for Rhinology and Allergology, Wiesbaden, Germany
6. Medical University of Łódź, Łódź, Poland
Disclosure: Prof Wahn reports receiving lecture fees from Stallergènes Greer, ALK-Abelló, Allergopharma, Novartis, Nutricia, Nestle, and MEDA; and consultation fees from Stallergènes Greer, ALK-Abelló, Allergopharma, Biomay, Novartis, Danone, and Hipp. Prof Jutel reports lecture fees from ALK-Abelló, Allergopharma, and Stallergènes Greer; clinical investigator fees from Stallergènes Greer, Allergopharma, Anergis, Allergy Therapeutics, Circassia, LETI, HAL Allergy, AstraZeneca, GlaxoSmithKline, Novartis, Teva, Vectura, Takeda, Roche, Janssen, Medimmune, and Chiesi; and has been on the advisory board for Allergopharma, Biomay, and UCB. Prof Kleine-Tebbe reports being a board member for ALK-Abelló, Novartis, LETI, and Bencard; consultancy fees from Merck, Circassia; grants to the institution from Circassia, LETI, and Stallergènes Greer; and lecture fees from Allergopharma, ALK-Abelló, Bencard, HAL Allergy, LETI, Lofarma, Novartis, and Stallergènes Greer. Prof Pfaar reports personal fees from Allergopharma, during the conduct of the FASIT and CSS reported; grants and personal fees from ALK-Abelló, Allergopharma, Stallergènes Greer, HAL Allergy Holding B.V./HAL Allergy GmbH, Bencard Allergie GmbH/Allergy Therapeutics, Biotech Tools S.A., Lofarma, Anergis S.A., and Laboratorios LETI/LETI Pharma; grants from Biomay, Nuvo, and Circassia; and personal fees from Novartis Pharma, MEDA Pharma, Sanofi US Services, Mobile Chamber Experts (a GA2LEN Partner), and Pohl-Boskamp. Prof Kuna reports being on the advisory board for Allergopharma, ALK-Abelló, Celon Pharma, Polpharma, Berlin-Chemie, Boehringer Ingelheim, Chiesi, Faes Pharma, HAL Allergy, Lekam, Novartis, Sandoz, and Teva; lecture fees from Adamed, Allergopharma, ALK-Abelló, AstraZeneca, Bayer, Berlin-Chemie, Boehringer Ingelheim, Chiesi, Faes Pharma, Polpharma, Pfizer, Novartis, Sandoz, and Teva; and congress fees from Berlin-Chemie, Boehringer Ingelheim, and Novartis.
Acknowledgements: Writing assistance was provided by Janet Fricker.
Support: The symposium and writing of this article was sponsored by Allergopharma GmbH & Co. KG.
Citation: EMJ Allergy and Immunol. 2017;2:36–44.
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.
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