European Academy of Allergy and Clinical Immunology task force report on ‘dose–response relationship in allergen-specific immunotherapy’
M. A. Calderón
National Heart and Lung Institute, Imperial College London, London, UK
Search for more papers by this authorJ. Kleine-Tebbe
Allergy & Asthma Center Westend, Berlin, Germany
Search for more papers by this authorL. Jacobsen
Research Centre for Prevention and Health, Glostrup University Hospital, Glostrup, Denmark
Search for more papers by this authorG. Passalacqua
Allergy and Respiratory Diseases, DIMI, Department of Internal Medicine, Genoa, Italy
Search for more papers by this authorP. A. Eng
Section of Allergy and Pulmonology, Children’s Hospital Aarau and Lucerne, Switzerland
Search for more papers by this authorE. M. Varga
Department of Paediatrics, Respiratory and Allergic Disease Division, Medical University Graz, Graz, Austria
Search for more papers by this authorC. Moreno
Seccion de Alergia, Hospital Reina Sofía, Cordoba, Spain
Search for more papers by this authorH. J. Malling
Allergy Unit, University Hospital, Copenhagen, Denmark
Search for more papers by this authorE. Alvarez-Cuesta
Allergy Division, Ramon & Cajal University Hospital, Alcala de Henares University, Madrid, Spain
Search for more papers by this authorS. Durham
National Heart and Lung Institute, Imperial College London, London, UK
Search for more papers by this authorP. Demoly
University Hospital of Montpellier, Montpellier, France
Search for more papers by this authorM. A. Calderón
National Heart and Lung Institute, Imperial College London, London, UK
Search for more papers by this authorJ. Kleine-Tebbe
Allergy & Asthma Center Westend, Berlin, Germany
Search for more papers by this authorL. Jacobsen
Research Centre for Prevention and Health, Glostrup University Hospital, Glostrup, Denmark
Search for more papers by this authorG. Passalacqua
Allergy and Respiratory Diseases, DIMI, Department of Internal Medicine, Genoa, Italy
Search for more papers by this authorP. A. Eng
Section of Allergy and Pulmonology, Children’s Hospital Aarau and Lucerne, Switzerland
Search for more papers by this authorE. M. Varga
Department of Paediatrics, Respiratory and Allergic Disease Division, Medical University Graz, Graz, Austria
Search for more papers by this authorC. Moreno
Seccion de Alergia, Hospital Reina Sofía, Cordoba, Spain
Search for more papers by this authorH. J. Malling
Allergy Unit, University Hospital, Copenhagen, Denmark
Search for more papers by this authorE. Alvarez-Cuesta
Allergy Division, Ramon & Cajal University Hospital, Alcala de Henares University, Madrid, Spain
Search for more papers by this authorS. Durham
National Heart and Lung Institute, Imperial College London, London, UK
Search for more papers by this authorP. Demoly
University Hospital of Montpellier, Montpellier, France
Search for more papers by this authorEdited by: Michael Wechsler
Abstract
To cite this article: Calderón MA, Larenas D, Kleine-Tebbe J, Jacobsen L, Passalacqua G, Eng PA, Varga EM, Valovirta E, Moreno C, Malling HJ, Alvarez-Cuesta E, Durham S, Demoly P. European Academy of Allergy and Clinical Immunology task force report on ‘dose–response relationship in allergen-specific immunotherapy’. Allergy 2011; 66: 1345–1359.
Background: For a century, allergen-specific immunotherapy (SIT) has proven to be an effective treatment for allergic rhinitis, asthma, and insect sting allergy. However, as allergen doses are frequently adapted to the individual patient, there are few data on dose-response relationship in SIT. Allergen products for SIT are being increasingly required to conform to regulatory requirements for human medicines, which include the need to demonstrate dose-dependent effects.
Methods: This report, produced by a Task Force of the EAACI Immunotherapy Interest Group, evaluates the currently available data on dose-response relationships in SIT and aims to provide recommendations for the design of future studies.
Results: Fifteen dose-ranging studies fulfilled the inclusion criteria and twelve reported a dose-response relationship for clinical efficacy. Several studies also reported a dose-response relationship for immunological and safety endpoints. Due to the use of different reference materials and methodologies for the determination of allergen content, variations in study design, and choice of endpoints, no comparisons could be made between studies and, as a consequence, no general dosing recommendations can be made.
Conclusion: Despite recently introduced guidelines on the standardization of allergen preparations and study design, the Task Force identified a need for universally accepted standards for the measurement of allergen content in SIT preparations, dosing protocols, and selection of clinical endpoints to enable dose-response effects to be compared across studies.
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