Abstract
The seventh “Future of the Allergists and Specific Immunotherapy (FASIT)” workshop held in 2019 provided a platform for global experts from academia, allergy clinics, regulatory authorities and industry to review current developments in the field of allergen immunotherapy (AIT). Key domains of the meeting included the following: (a) Biomarkers for AIT and allergic asthma; (b) visions for the future of AIT; (c) progress and data for AIT in asthma and the updates of GINA and EAACI Asthma Guidelines (separated for house dust mite SCIT, SLIT tablets and SLIT drops; patient populations) including a review of clinically relevant endpoints in AIT studies in asthma; (d) regulatory prerequisites such as the “Therapy Allergen Ordinance” in Germany; (e) optimization of trial design in AIT clinical research; (f) challenges planning and conducting phase III (field) studies and the future role of Allergen Exposure Chambers (AEC) in AIT product development from the regulatory point of view. We report a summary of panel discussions of all six domains and highlight unmet needs and possible solutions for the future.
Original language | English |
---|---|
Journal | Allergy: European Journal of Allergy and Clinical Immunology |
Volume | 74 |
Issue number | S108 |
Pages (from-to) | 3-25 |
Number of pages | 23 |
ISSN | 0105-4538 |
DOIs | |
Publication status | Published - 01.12.2019 |
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In: Allergy: European Journal of Allergy and Clinical Immunology, Vol. 74, No. S108, 01.12.2019, p. 3-25.
Research output: Journal Articles › Scientific review articles › Research
TY - JOUR
T1 - Perspectives in allergen immunotherapy: 2019 and beyond
AU - Pfaar, Oliver
AU - Agache, Ioana
AU - de Blay, Frédéric
AU - Bonini, Sergio
AU - Chaker, Adam M.
AU - Durham, Stephen R.
AU - Gawlik, Radoslaw
AU - Hellings, Peter W.
AU - Jutel, Marek
AU - Kleine-Tebbe, Jörg
AU - Klimek, Ludger
AU - Kopp, Matthias V.
AU - Nandy, Andreas
AU - Rabin, Ronald L.
AU - van Ree, Ronald
AU - Renz, Harald
AU - Roberts, Graham
AU - Salapatek, Anne Marie
AU - Schmidt-Weber, Carsten B.
AU - Shamji, Mohamed H.
AU - Sturm, Gunter J.
AU - Virchow, J. Christian
AU - Wahn, Ulrich
AU - Willers, Christoph
AU - Zieglmayer, Petra
AU - Akdis, Cezmi A.
N1 - Funding Information: The authors would like to thank Susanne Thum‐Oltmer*, Germany; Kristina Duwensee*, Germany, whose participation in the FASIT workshop provided the content of this supplement and Allergopharma (Reinbek, Germany) for organizing and funding the workshop. They also thank Stefan Vieths and Vera Mahler, Paul‐Ehrlich‐Institut, Germany for the discussion and their valuable input during the meeting as well as their critical review of the manuscript. Finally, the authors acknowledge medical writing and editorial support for the preparation of this supplement from Annemie Narkus (MC Narkus GmbH, Germany), which was funded by Allergopharma GmbH & Co. KG. *Employees of Allergopharma GmbH & Co. KG Funding Information: This paper has been produced in collaborative work of all coauthors based on their presentations during the FASIT meeting. The authors did not receive any fee for writing, editing or graphics. OP reports grants and personal fees from ALK‐Abelló, Allergopharma, Stallergènes Greer, HAL Allergy Holding BV/HAL Allergie GmbH, Bencard Allergie GmbH/Allergy Therapeutics, Lofarma, ASIT Biotech Tools SA, Laboratorios LETI/LETI Pharma, Anergis S.A; grants from Biomay, Nuvo, Circassia, Glaxo Smith Kline; personal fees from MEDA Pharma/MYLAN, Mobile Chamber Experts (a GA2LEN Partner), Indoor Biotechnologies, Astellas Pharma Global, outside the submitted work. IA has nothing to disclose. FdB reports personal fees from Aimmune; grants from Stallergenes‐Greer, Chiesi, ALK, Mundipharma, Novartis; board membership of Stallergenes‐Greer, Novartid, ALK, Mundipharma, Boehringer, Astra Zeneca, Medpharma, outside the submitted work. SB has nothing to disclose. AMC reports institutional fees for advisory via Technical University Munich from Allergopharma in relation to this work. Further grants for clinical studies and research and other from Allergopharma, ALK‐Abelló, Bencard/Allergy Therapeutics, ASIT Biotech, Lofarma, GSK, Novartis, LETI, Roche, Zeller, Astra Zeneca, SanofiGenzyme; has received travel support from the European Academy of Allergy and Clinical Immunology (EAACI), DGAKI, and SMI, outside the submitted work. In addition, he has a patent: A ratio of immune cells as prognostic indicator of therapeutic success in allergen‐specific immunotherapy: 17 177 681.8 not licensed at present. SRD reports consultancy and lecture fees from ALK; lecture fees from Allergopharma; consultancy fees from Adiga, Biomay, UCB; grants and nonfinancial support from GSK, ALK. RG personal fees from ALK‐Abelló, Allergopharma, HAL. PH has received grants and/or speaker fees of Stallergenes‐Greer, ALK‐Abelló, Sanofi and Mylan. MJ reports personal fees from ALK‐Abelló, Allergopharma, Stallergènes, Anergis, Allergy Therapeutics, Circassia, Leti, Biomay, HAL, during the conduct of the study; personal fees from Astra‐Zeneca, GSK, Novartis, Teva, Vectura, UCB, Takeda, Roche, Janssen, Medimmune, Chiesi, outside the submitted work. JKT reports personal fees from Allergopharma, ALK‐Abelló, Bencard/Allergy Therapeutics, HAL, LETI, Lofarma, Merck (USA), and Stallergenes Greer for lecturing, conduct of studies or consultancy; personal fees from AllergenOnline (University of Nebraska), AstraZeneca, Dr Pfleger, German Society of Allergology and Clinical Immunology, Glaxo, Novartis, InfectoPharm, Sanofi, ThermoFisher for lecturing or consultancy. LK reports grants and personal fees from Allergopharma (Germany), GSK (Great Britain), Novartis (Switzerland) Bionorica (Germany); personal fees from MEDA (Sweden), Boehringer Ingelheim, Lofarma (Italy); grants from Biomay (Austria), HAL (Netherlands), LETI (Spain), Roxall (Germany), Bencard (Great Britain), outside the submitted work. MVK has received a speaker honorarium or consultant fees from the following companies: ALK‐Abelló, Allergopharma, Boehringer‐Ingelheim, Chiesi; Glaxo; Infectopharm; Meda, Sanofi‐Aventis, Leti Pharma, Novartis, Vertex. AN is employee of Allergopharma GmbH & Co. KG. RLR reports no conflict of interest. His contributions to this article are an informal communication and represent his own best judgement. These comments do not bind or obligate the US Food and Drug Administration. RvR reports consultancy fees from HAL Allergy BV, Angany Inc, Citeq BV. HR has nothing to disclose according to the authorship. GR reports other from ALK‐Abelló, outside the submitted work; and Coordinators of the EAACI Allergen Immunotherapy Guidelines. AMS has nothing to disclose. CBSW reports grants and personal fees from Allergopharma, Leti, during the conduct of the study; grants from EIT health, personal fees from FNF, outside the submitted work; in addition, he has a patent biomarker pending. MHS reports grants from ALK‐Abelló, Regeneron, Merck; personal consultancy fees via Imperial College London from ASIT Biotech; grants and personal lecture fees from ALK‐Abelló; grants from ASIT Biotech; personal lecture fees from Allergopharma, grants from Immune Tolerance Network, outside the submitted work. GJS reports grants and personal fees from ALK‐Abelló; personal fees from Novartis, Bencard, Stallergènes, HAL, Allergopharma, Mylan, outside the submitted work. JCV has nothing to disclose. UW reports honoraria for consultancy as well as lecture fees from Allergopharma, Stallergenes, ALK, Roxall, Sanofi‐Aventis, Novartis, Berlin‐Chemie, Danone. CW is employee of Allergopharma GmbH & Co. KG. PZ has nothing to disclose. CAA received grants from Allergopharma, Idorsia, Swiss National Science Foundation, Christine Kühne‐Center for Allergy Research and Education, European Commission's Horison's 2020 Framework Programme, Cure, Novartis, Astra Zeneca, Scibase. Publisher Copyright: © 2019 The Authors. Allergy published by John Wiley & Sons Ltd Copyright: Copyright 2020 Elsevier B.V., All rights reserved.
PY - 2019/12/1
Y1 - 2019/12/1
N2 - The seventh “Future of the Allergists and Specific Immunotherapy (FASIT)” workshop held in 2019 provided a platform for global experts from academia, allergy clinics, regulatory authorities and industry to review current developments in the field of allergen immunotherapy (AIT). Key domains of the meeting included the following: (a) Biomarkers for AIT and allergic asthma; (b) visions for the future of AIT; (c) progress and data for AIT in asthma and the updates of GINA and EAACI Asthma Guidelines (separated for house dust mite SCIT, SLIT tablets and SLIT drops; patient populations) including a review of clinically relevant endpoints in AIT studies in asthma; (d) regulatory prerequisites such as the “Therapy Allergen Ordinance” in Germany; (e) optimization of trial design in AIT clinical research; (f) challenges planning and conducting phase III (field) studies and the future role of Allergen Exposure Chambers (AEC) in AIT product development from the regulatory point of view. We report a summary of panel discussions of all six domains and highlight unmet needs and possible solutions for the future.
AB - The seventh “Future of the Allergists and Specific Immunotherapy (FASIT)” workshop held in 2019 provided a platform for global experts from academia, allergy clinics, regulatory authorities and industry to review current developments in the field of allergen immunotherapy (AIT). Key domains of the meeting included the following: (a) Biomarkers for AIT and allergic asthma; (b) visions for the future of AIT; (c) progress and data for AIT in asthma and the updates of GINA and EAACI Asthma Guidelines (separated for house dust mite SCIT, SLIT tablets and SLIT drops; patient populations) including a review of clinically relevant endpoints in AIT studies in asthma; (d) regulatory prerequisites such as the “Therapy Allergen Ordinance” in Germany; (e) optimization of trial design in AIT clinical research; (f) challenges planning and conducting phase III (field) studies and the future role of Allergen Exposure Chambers (AEC) in AIT product development from the regulatory point of view. We report a summary of panel discussions of all six domains and highlight unmet needs and possible solutions for the future.
UR - http://www.scopus.com/inward/record.url?scp=85077081957&partnerID=8YFLogxK
U2 - 10.1111/all.14077
DO - 10.1111/all.14077
M3 - Scientific review articles
C2 - 31872476
AN - SCOPUS:85077081957
SN - 0105-4538
VL - 74
SP - 3
EP - 25
JO - Allergy: European Journal of Allergy and Clinical Immunology
JF - Allergy: European Journal of Allergy and Clinical Immunology
IS - S108
ER -