We found a match
Your institution may have access to this item. Find your institution then sign in to continue.
- Title
European Academy of Allergy and Clinical Immunology task force report on 'dose-response relationship in allergen-specific immunotherapy'.
- Authors
Calderón, M. A.; Larenas, D.; Kleine-Tebbe, J.; Jacobsen, L.; Passalacqua, G.; Eng, P. A.; Varga, E. M.; Valovirta, E.; Moreno, C.; Malling, H. J.; Alvarez-Cuesta, E.; Durham, S.; Demoly, P.
- 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. Abstract 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.
- Subjects
DOSE-response relationship in biochemistry; IMMUNOTHERAPY; ALLERGY treatment; ALLERGENS; EUROPEAN Academy of Allergology &; Clinical Immunology
- Publication
Allergy, 2011, Vol 66, Issue 10, p1345
- ISSN
0105-4538
- Publication type
Article
- DOI
10.1111/j.1398-9995.2011.02669.x