International Consensus on Allergen Immunotherapy II: Mechanisms, standardization, and pharmacoeconomics - 05/02/16
Abstract |
This article continues the comprehensive international consensus (ICON) statement on allergen immunotherapy (AIT). The initial article also recently appeared in the Journal. The conclusions below focus on key mechanisms of AIT-triggered tolerance, requirements in allergen standardization, AIT cost-effectiveness, and regulatory guidance. Potential barriers to and facilitators of the use of AIT are described in addition to future directions. International allergy specialists representing the European Academy of Allergy and Clinical Immunology; the American Academy of Allergy, Asthma & Immunology; the American College of Allergy, Asthma and Immunology; and the World Allergy Organization critically reviewed the existing literature and prepared this summary of recommendations for best AIT practice. The authors contributed equally and reached consensus on the statements presented herein.
Le texte complet de cet article est disponible en PDF.Key words : International consensus, allergy, immunotherapy, allergen vaccine, allergen standardization, pharmacoeconomics, cost-effectiveness, mechanisms, tolerance, marketing authorization, regulatory authorities, unmet needs
Abbreviations used : AIT, AS, BAU, Breg, CUA, D50, DC, EMA, EU, FOXP3, ICER, IHRP, ILC, ILC2, MA, NPP, QALY, SCIT, SLIT, ST, TLR, Treg, VIT
Plan
Disclosure of potential conflict of interest: M. Jutel has received consultancy fees from Anergis and has received lecture fees from Allergopharma. S. Bonini has received travel support and is an expert on secondment at the European Medicine Agency. A. W. Burks is on the FARE and World Allergy Organization boards; is on the Murdoch Children's Research Institute Advisory Board; is an unpaid consultant for Dynavax Technologies, Perrigo Company (PBN Nutritionals), and Perosphere; has received consultancy fees from GLG Research (Gerson Lehrman Group), ActoGeniX, Genentech, Sanofi US Services, and Valeant Pharmaceuticals North America; is employed by the University of North Carolina; has patents US5558869, US55973121, US6441142, US6486311, US6835824, US7485708, and US7879977; has received payment for developing educational presentations from Current Views 2012; has stock/stock options in Allertein and Mastcell Pharmaceuticals; and has received travel support for various grand rounds and presentations. M. Calderon is on the boards for ALK-Abelló and HAL Allergy, has received consultancy fees from ALK-Abelló and Stallergenes, and has received lecture fees from ALK-Abelló, Stallergenes, Merck, and Allergopharma. L. Cox has received personal fees from Greer and is the lead author on one of the studies discussed in the correspondence (publication date 2011) but has had no relationship with the sponsoring company in the past 36 months. P. Demoly has received consultancy fees from ALK-Abelló, Circassia, Stallergenes-Greer, Allergopharma, DBV, Thermo Fisher Scientific, Chiesi, and Pierre Fabre Medicament and has received lecture fees from Menarini, MSD, and AstraZeneca. A. J. Frew is on the ALK-Abelló board and has received research support from NIHR (UK). D. Larenas is on the CMICA board with no financial gain; has received consultancy fees from MEDA, Pfizer, MIT, BI, Novartis Glenmark, and Chiesi; has received research support from Novartis, Pfizer, MEDA, UCB, GlaxoSmithKline, Astra Zeneca, Senosiain, Sanofi, MSD, TEVA, and Carnot; has received lecture fees from Novartis, Pfizer, MEDA, Astra Zeneca, Sanofi, MSD, TEVA, and Chiesi; has received payment for development of educational presentations from Glenmark; and has received travel support from Novartis, Pfizer, MEDA, AstraZeneca, Sanofi, MSD, and Chiesi. M Levin is on the boards for the Allergy Society of South Africa and the Allergy Foundation of South Africa; has received consultancy fees from Mylan, Pharma Dynamics, and INNOVA Pharma; has received research support from Mylan, the Medical Research Council of South Africa, Thermo Fisher, GlaxoSmithKline/Aspen, AstraZeneca, Cipla, Astellas, Pharma Dynamics, and Beiersdorf; and has received lecture fees from Cipla, Takeda Nycomed, Pharma Dynamics, and Novartis. H. Nelson has received research support from Circassia and has received consulting fees from Circassia, Merck, Pearl Therapeutics and AstraZeneca. O. Pfaar has received research grants for his institution from Allergopharma (Germany), ALK-Abelló (Denmark), Stallergenes (France), HAL-Allergy (Netherlands), Artu Biologicals (Netherlands), Allergy Therapeutics/Bencard (United Kingdom/Germany), Hartington (Spain), Lofarma (Italy), Novartis/Leti (Germany/Spain), GlaxoSmithKline (United Kingdom), Essex-Pharma (Germany), Cytos (Switzerland), Curalogic (Denmark), Roxall (Germany), Biomay (Austria), Thermo Fisher (United States), Circassia (United Kingdom), E.U (FP-7-Health-2013-Innovation 1), Biotech Tools (Belgium), and MEDA-Pharma (Sweden); has received personal payments as consultant for Allergopharma (Germany), Anergis (Switzerland), Bencard (Germany), HAL-Allergy (Netherlands), Novartis/LETI (Germany), MEDA-Pharma (Germany), ALK-Abelló (Denmark), Biotech Tools (Belgium), GfK Bridgehead (United Kingdom), NAVIGANT-consulting (United States), Sanofi (United States), Guidepoint Global Advisors (United States), Pohl-Boskamp (Germany), Stallergenes (France), and Mobile Chamber Experts (a GA2LEN partner, Germany); has received personal payments for lectures, book chapters, or educational presentations from ALK-Abelló (Denmark), Allergopharma (Germany), Stallergenes (France), HAL-Allergy (Germany/Netherlands), Allergy Therapeutics/Bencard (United Kingdom/Germany), Hartington (Spain), Lofarma (Italy), Novartis/Leti (Germany/Spain), GlaxoSmithKline (Germany), Roxall (Germany), Thermo-Fisher (Germany), MEDA-Pharma (Germany), Schattauer (Germany), Springer (Germany). and GlaxoSmithKline (Germany); has served as advisor and on the speakers' bureaus for some of the aforementioned companies; has received travel grants from HAL-Allergy (Netherlands), Allergopharma (Germany), the European Academy of Allergy and Clinical Immunology (EAACI), the German Society for Allergology and Clinical Immunology (DGAKI), and the German Respiratory Society (DGP); and is the current chairman of the Immunotherapy Interest Group (IT IG) of the EAACI and is secretary of the ENT section of the DGAKI. R van Ree has received research support from the European Commission; has received consultancy fees as the Scientific Advisory Board Chair for HAL Allergy BV; is Vice President of the EAACI; has received consultancy fees from Bayer CropScience; and has received lecture fees from Thermo Fisher Scientific. H. Sampson, as of November 1, 2015, is a part-time employee of DBV Technologies and serves as their Chief Scientific Officer; DBV Technologies is developing an epicutaneous patch for the treatment of peanut allergy and other disorders. G. Du Toit has received research support from the National Institute of Allergy and Infectious Diseases (NIAID; NO1-AI-15416 [contract] and UM1AI109565 [grant], covering salary); has received contribution to NIAID contract/grant from Food Allergy and Research Education (FARE); has received Contribution to the KCL Division of Asthma, Allergy & Lung Biology (of which Pediatric Allergy Research is a part) from MRC & Asthma UK Centre; has received a BRC award to Guy's and St Thomas' NHS Foundation from the UK Department of Health through NIHR; and has equity holding in FoodMaestro. R Gerth van Wijk has received consultancy fees from MSD, HAL, Crucell, ALK-Abelló, Novartis, and Emerade; has received research support from NOW, STW, Novartis, Biomay, and DBV; has received lecture fees from Allergopharma and Thermo Fisher; has received payment for manuscript preparation from Chiesi; and receives royalties from de Tijdstroom and Bohn, Stafleu, van Loghum. C. A. Akdis has received consultancy fees from Actelion, Aventis, Stallergenes, Allergopharma, and Circacia; is employed by the Swiss Institute of Allergy and Asthma Research, University of Zurich, Switzerland; has received research support from Novartis, PREDICTA (European Commission's Seventh Framework programme no. 260895), the Swiss National Science Foundation, MeDALL (European Commission's Seventh Framework Programme no. 261357), and the Christine Kühne-Center. The rest of the authors declare that they have no relevant conflicts of interest. |
Vol 137 - N° 2
P. 358-368 - février 2016 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
L’accès au texte intégral de cet article nécessite un abonnement.
Déjà abonné à cette revue ?