International Consensus on Allergen Immunotherapy II: Mechanisms, standardization, and pharmacoeconomics - 05/02/16
Doi : 10.1016/j.jaci.2015.12.1300
Marek Jutel, MD a, ⁎ 
, Ioana Agache, MD b, Sergio Bonini, MD c, A. Wesley Burks, MD d, Moises Calderon, MD e, Walter Canonica, MD f, Linda Cox, MD g, Pascal Demoly, MD h, Antony J. Frew, MD, FRCP i, Robyn O'Hehir, FRACP, PhD j, Jörg Kleine-Tebbe, MD k, Antonella Muraro, MD, PhD l, Gideon Lack, MD m, Désirée Larenas, MD n, Michael Levin, MD o, Bryan L. Martin, MD p, Harald Nelson, MD q, Ruby Pawankar, MD r, Oliver Pfaar, MD s, Ronald van Ree, PhD t, Hugh Sampson, MD u, James L. Sublett, MD v, Kazunari Sugita, MD w, George Du Toit, MD x, Thomas Werfel, MD y, Roy Gerth van Wijk, MD z, Luo Zhang, MD aa, Mübeccel Akdis, MD w, Cezmi A. Akdis, MD w
, Ioana Agache, MD b, Sergio Bonini, MD c, A. Wesley Burks, MD d, Moises Calderon, MD e, Walter Canonica, MD f, Linda Cox, MD g, Pascal Demoly, MD h, Antony J. Frew, MD, FRCP i, Robyn O'Hehir, FRACP, PhD j, Jörg Kleine-Tebbe, MD k, Antonella Muraro, MD, PhD l, Gideon Lack, MD m, Désirée Larenas, MD n, Michael Levin, MD o, Bryan L. Martin, MD p, Harald Nelson, MD q, Ruby Pawankar, MD r, Oliver Pfaar, MD s, Ronald van Ree, PhD t, Hugh Sampson, MD u, James L. Sublett, MD v, Kazunari Sugita, MD w, George Du Toit, MD x, Thomas Werfel, MD y, Roy Gerth van Wijk, MD z, Luo Zhang, MD aa, Mübeccel Akdis, MD w, Cezmi A. Akdis, MD w a Department of Clinical Immunology, Wroclaw Medical University, and “ALL-MED” Medical Research Institute, Wroclaw, Poland
b Faculty of Medicine, Transylvania University, Brasov, Romania
c Second University of Naples and IFT-CNR, Rome, and Expert-on-Secondment European Medicines Agency, London, United Kingdom
d Department of Pediatrics, University of North Carolina, Chapel Hill, NC
e Section of Allergy and Clinical Immunology, Imperial College London, National Heart and Lung Institute, Royal Brompton Hospital, London, United Kingdom
f Allergy & Respiratory Diseases Clinic, DIMI University of Genoa, IRCCS AOU San Martino, Genova, Italy
g Allergy and Asthma Center, Fort Lauderdale, Fla
h University Hospital of Montpellier-INSERM U657, Montpellier, France
i Department of Respiratory Medicine, Royal Sussex County Hospital, Brighton, United Kingdom
j Department of Allergy, Immunology and Respiratory Medicine, The Alfred Hospital and Monash University, Melbourne, Australia
k Allergy & Asthma Center Westend, Berlin, Germany
l Department of Mother and Child Health, Padua General University Hospital, Padua, Italy
m Division of Asthma, Allergy and Lung Biology, MRC and Asthma UK Centre in Allergic Mechanisms of Asthma, King's College London, and the Children's Allergy Unit, Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom
n Hospital Médica Sur, Mexico City, Mexico
o Division of Allergy, School of Child and Adolescent Health, Red Cross War Memorial Children's Hospital, Cape Town, South Africa
p Department of Allergy and Immunology, Walter Reed Army Medical Center, Silver Spring, Md
q National Jewish Health, Denver, Colo
r Department of Pediatrics, Nippon Medical School, Tokyo, Japan
s Center for Rhinology and Allergology, Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Mannheim, Mannheim, Germany
t Academic Medical Center, Departments of Experimental Immunology and of Otorhinolaryngology, University of Amsterdam, Amsterdam, The Netherlands
u Department of Pediatrics, Division of Allergy-Immunology, and the Jaffe Food Allergy Institute at the Icahn School of Medicine at Mount Sinai, New York, NY
v Department of Pediatrics, Section of Allergy and Immunology, University of Louisville School of Medicine, Louisville, Ky
w Swiss Institute for Allergy and Asthma Research, University of Zurich, and Christine Kühne-Center for Allergy Research and Education, Davos, Switzerland
x Department of Pediatric Allergy, Division of Asthma, Allergy & Lung Biology, King's College London, and MRC & Asthma UK Centre in Allergic Mechanisms of Asthma, London, United Kingdom
y Department of Dermatology and Allergy, Division of Immunodermatology and Allergy Research, Hannover Medical School, Hannover, Germany
z Erasmus Medical Center, Rotterdam, The Netherlands
aa Beijing Institute of Otolaryngology, Beijing, China
∗Corresponding author: Marek Jutel, MD, Department of Clinical Immunology, Wroclaw Medical University, Chalubinskiego 5, PL-50-368 Wrocław, Poland.Department of Clinical ImmunologyWroclaw Medical UniversityChalubinskiego 5WrocławPL-50-368Poland
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. |
© 2015
American Academy of Allergy, Asthma & Immunology. Publié par Elsevier Masson SAS. Tous droits réservés.
Vol 137 - N° 2
P. 358-368 - février 2016 Retour au numéro
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