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Translating knowledge into clinical practice
European Academy of Allergy and Clinical Immunology
Guidelines Part 2: Recommendations
EAACI GUIDELINES Allergen Immunotherapy Guidelines
Part 2: Recommendations
Editorial Board Ioana Agache
Liz Angier Andreas Bonertz Sangeeta Dhami
Montserrat Fernandez Rivas Roy Gerth van Wijk
Susanne Halken Marek Jutel
Susanne Lau Giovanni Pajno
Oliver Pfaar Dermot Ryan
Aziz Sheikh Gunter Sturm
Ronald van Ree Eva-Maria Varga
The European Academy of Allergy and Clinical Immunology (EAACI) is a non-profit organisation active in the field of allergic and immunologic diseases such as asthma, rhinitis, eczema, occupational allergy, food and drug allergy and anaphylaxis. EAACI was founded in 1956 in Florence and has become the largest medical association in Europe in the field of allergy and clinical immunology. It includes over 10,000 members from 122 countries, as well as over 60 national and international member societies.
© European Academy of Allergy and Clinical Immunology (EAACI) 2017
All rights reserved
ISBN Number: 978-3-9524815-1-6
For all EAACI Members and to our patients
VAllergen Immunotherapy Guidelines
Prevention of allergy 1 EAACI guidelines on allergen immunotherapy
Prevention of allergy1 2 Venom immunotherapy25 EAACI guidelines on allergen immunotherapyHymenoptera venom allergy 3 IgE-food allergy49 EAACI guidelines on allergen immunotherapy IgE-mediated food allergy 4 Rhinoconjunctivitis71 EAACI guidelines on allergen immunotherapy Allergic rhinoconjunctivitis 5 Current provision115 Challenges in the implementation of the EAACI AIT guidelinesA situational analysis of current provision of allergen immunotherapy 6 Regulation of Allergen Products129 Challenges in the implementation of the EAACI AIT guidelinesA global perspective on the regulation of allergen products 7 Health Economic Analysis147 Health economic analysis of AIT for the management of allergic rhinitis, asthma, food allergy and venom allergy
A systematic overview
VIIAllergen Immunotherapy Guidelines
EAACI has a long history and strong ethos in implementing the latest research findings to deliver better healthcare for patients with allergies. Over the last decades this mission has become even more important with allergic diseases now affecting the lives of millions of people around the world. This represents a major burden for patients as well as their clinicians, governments, legislators and regulators. The current challenge is to deliver appropriate treatments that are able to prevent lifetime disabilities, shifting from “treating a disease“ to “promote health” in a sustainable context.
Allergen immunotherapy (AIT) has been used for a century. Several terms including “desensitization”, “hyposensitization“ and “vaccines” have been used, and often misused, to indicate administration of incremental doses of allergenic substances to reduce the clinical manifestations of allergy. However AIT has also been the subject of considerable controversy in terms of its efficacy. The dispute has impacted on the dissemination of knowledge about AIT, the availability of the products in many countries and the relevant policies for their reimbursement. Some of these issues result from an inadequate translation of the scientific data into daily practice, with clinical judgment being established on expert opinion instead of the objective evaluation of valid scientific studies.
These Guidelines for clinical practice aim to define the current literature and they have synthesized the scientific evidence in a well-structured, systematic and reproducible process. This has been combined with the expertise of clinicians, the preferences of patients and the needs of policy makers. The purpose has been to develop clinically valid, operational recommendations which serve as a strong basis to help the allergist to advocate for AIT, practitioners to refer patients onto appropriate management, the patient to request the best standard of care for their disease and quality of life and the regulators to evaluate the sustainability for the health-care system. Of note, these recommendations cannot, and will not, stand forever but will need to be revised as soon as new research developments are available.
These guidelines follow the previous guidelines on Food Allergy and Anaphylaxis. Together, they have defined a crucial change resulting in a framework of a rigorous methodological approach for future guidelines. The ambition for EAACI is to drive the perception of clinicians and stakeholders from relying on old “pre-cooked recipes“ to focusing on critical thinking and applicability of the recommendations.
Almost all the EAACI groups have worked on these AIT Guidelines. It is thanks to the tireless efforts of the many task forces Chairs, to the Sections and to the Interest Groups that we have been able to develop comprehensive Guidelines. We also need to thank the commitment of the EAACI members who contributed through the public comment, the Board of Officers and the Executive Committee and almost 100 experts from all over the world who have worked with enthusiasm and who have been instrumental to maintain the pace over the last 2 years. We feel privileged for their vision and continuous support.
This is, indeed, the start of the journey. Implementing the Guidelines both nationally and internationally will measure the success of this project. We are sure that EAACI members have the strength and dedication to accomplish this achievement.
Antonella Muraro Chair of EAACI AIT Guidelines and EAACI Past President (2015-2017)
IXAllergen Immunotherapy Guidelines
List of contributors
Ioana Agache Transylvania University Brasov, Faculty of Medicine, Department of Allergy and Clinical Immunology, Brasov, Romania
Cezmi A. Akdis Swiss Institute of Allergy and Asthma Research, University Zurich, Davos, Switzerland
Montserrat Alvaro-Lozano Paediatric Allergy and Clinical Immunology Section, Hospital Sant Joan de Deu, Universitat de Barcelona, Barcelona, Spain
Elizabeth Angier Department of Clinical Immunology and Allergy, Northern General Hospital, Herries Road, Sheffield, UK
Ignacio J. Ansotegui Department of Allergy & Immunology, Hospital Quironsalud Bizkaia, Bilbao, Spain
Darío Antolín-Amérigo Immune System Diseases Department-Allergy Unit. Príncipe de Asturias University Hospital. Department of Medicine and medical specialties. Universidad de Alcalá, Madrid, Spain
Stefania Arasi Department of Pediatrics, Allergy Unit, University of Messina, Italy and Department of Pediatric Pneumology and Immunology, Charité Universitätsmedizin Berlin
Miqdad Asaria Research Fellow Centre for Health Economics, University of York, UK
Domingo Barber Universidad CEU San Pablo, Madrid, Spain
Kirsten Beyer Pediatric Pneumology and Immunology, Charite Universitätsmedizin, Berlin, Germany
M. Beatrice Bilò Allergy Unit, Department of Internal Medicine, University Hospital of Ancona, Ancona, Italy
Carsten Bindslev-Jensen Department of Dermatology and Allergy Centre, Odense University Hospital, Odense, Denmark
Yanne Boloh EAACI Patient Organization Committee- Region de Mans, France
Andreas Bonertz Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Langen, Germany
Sergio Bonini Department of Clinical and Experimental Medicine, University of Campania Luigi Vanvitelli, Naples, Italy
Jennifer Bridgewater US Food and Drug Administration, Silver Spring, MD, USA
Wesley Burks Department of Pediatrics, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA
Moises A. Calderon Allergy and Clinical Immunology, National Heart and Lung Institute, Imperial College London, UK
Victoria Cardona Allergy Section, Department of Internal Medicine, Hospital Vall d’Hebron, Barcelona, Spain
Thomas Casale University of South Florida, Tampa, FL, USA
Ewa Cichocka-Jarosz Department of Pediatrics, Jagiellonian University Medical College, Krakow, Poland
Cemal Cingi Department of ENT, Eskisehir Osmangazi University Medical Faculty, Eskisehir, Turkey
Sangeeta Dhami Evidence-Based Health Care Ltd, Edinburgh, UK
George Du Toit Division of Asthma, Allergy and Lung Biology, Department of Paediatric Allergy, MRC & Asthma Centre in Allergic Mechanisms of Asthma, King’s College London, London, UK; St Thomas NHS Foundation trust, London, UK
Stephen Durham National Heart and Lung Institute, Imperial College, London, UK
X Allergen Immunotherapy Guidelines
Motohiro Ebisawa Department of Allergy, Clinical Research Center for Allergy & Rheumatology, Sagamihara National Hospital, Sagamihara, Kanagawa, Japan
Philippe Eigenmann University Hospitals of Geneva and Medical School of the University of Geneva, Geneva, Switzerland
Jean L. Fauquert CHU Clermont-Ferrand University Hospital (CHU Estaing), Unité d’allergologie de l’enfant, INSERM, Clermont-Ferrand, France
Montserrat Fernandez-Rivas Allergy Department, Hospital Clinico San Carlos, IdISSC, Madrid, Spain