Your browser doesn't support javascript.
loading
Major Allergen Content in Allergen Immunotherapy Products: The Limited Value of Numbers
Becker, S; Fassio, F; Muñoz-Cano, R; Klimek, L; Vidal, C; Heath, M. D; Kündig, T. M; Vogelberg, C; Toran, C; Jensen-Jarolim, E.
Affiliation
  • Becker, S; University Medical Center Tübingen. Head and Neck Surgery. Department of Otorhinolaryngology. Tübingen. Germany
  • Fassio, F; Centro Studi Allergie ETS. Pistoia. Italy
  • Muñoz-Cano, R; Hospital Clinic. Allergy Department. Barcelona. Spain
  • Klimek, L; Center for Rhinology and Allergy. Wiesbaden. Germany
  • Vidal, C; University of Santiago de Compostela. Faculty of Medicine. Complejo Hospitalario Universitario de Santiago. Santiago de Compostela. Spain
  • Heath, M. D; Allergy Therapeutics (UK) Ltd. Worthing. United Kingdom
  • Kündig, T. M; University of Zurich. University Hospital Zurich. Department of Dermatology. Zurich. Switzerland
  • Vogelberg, C; Technical University of Dresden. University Hospital Carl Gustav Carus. Department of Pediatric Pulmonology and Allergy. Dresden. Germany
  • Toran, C; Allergy Therapeutics Ibérica. Barcelona. Spain
  • Jensen-Jarolim, E; Medical University of Vienna. Institute of Pathophysiology and Allergy Research. Centre of Pathophysiology, Infectiology and Immunology. Vienna. Austria
J. investig. allergol. clin. immunol ; 32(5): 345-356, 2022. ilus
Article in English | IBECS | ID: ibc-212730
Responsible library: ES1.1
Localization: ES15.1 -BNCS
ABSTRACT
The prevalence of allergic disorders has increased drastically over the last 50 years to the extent that they can be considered epidemic.At present, allergen-specific immunotherapy (AIT) is the only therapy that targets the underlying cause of allergic disorders, and evidenceof its superiority is based on data accumulated from clinical trials and observational studies demonstrating efficacy and safety. However,several aspects remain unresolved, such as harmonization and standardization of manufacturing and quantification procedures acrossmanufacturers, homogeneous reporting of strength, and the establishment of international reference standards for many allergens. Thisarticle discusses issues related to the measurement of major allergen content in AIT extracts, raising the question of whether comparison ofproducts from different manufacturers is an appropriate basis for selecting a specific AIT product. Allergen standardization in immunotherapyproducts is critical for ensuring quality and, thereby, safety and efficacy. However, lack of harmonization in manufacturing processes,allergen quantification (methodologies and references), national regulatory differences, clinical practice, and labeling shows that thecomparison of AIT products based solely on major allergen amounts is not rational and, in fact, impossible. Moreover, when rating theinformation given for a specific product, it is necessary to take into account further inherent characteristics of products and their applicationin clinical practice, such as the state of extract modification, addition of adjuvant or adjuvant system, route of administration (sublingual/subcutaneous), and cumulative dose as per posology (including the volume per administration). Finally, only convincing clinical data canserve as the basis for product-specific evaluation and cross-product comparability of individual products. (AU)
RESUMEN
La prevalencia de las enfermedades alérgicas se ha incrementado drásticamente en los últimos 50 años y hoy pueden considerarse unaepidemia. Actualmente, la inmunoterapia específica con alérgenos (ITA) es el único tratamiento dirigido a la causa subyacente de lasenfermedades alérgicas y su superioridad se basa en resultados de ensayos clínicos/estudios observacionales que demuestran su eficaciay seguridad. Pero quedan aspectos sin resolver, como la armonización y estandarización de los procesos de fabricación y cuantificaciónentre fabricantes, la declaración homogénea de la potencia y el establecimiento de estándares internacionales de referencia. En este artículo se discuten aspectos relacionados con la medida del contenido de alérgenos mayores en los extractos de ITA, cuestionandosi, como base para elegir entre productos, es apropiada la comparación entre diferentes fabricantes. La estandarización alergénica escrucial para asegurar la calidad y, por tanto, la seguridad y eficacia de la ITA. Sin embargo, la falta de armonización en los procesos defabricación, la cuantificación alergénica, las diferencias regulatorias, la práctica clínica y el etiquetado, demuestran que comparar productosbasándose únicamente en la cantidad de alérgeno mayor no está justificado y es imposible. Además, cuando se evalúa la informaciónpara un determinado producto, deben tenerse en cuenta las características propias de cada producto y su uso clínico, como el estado dela modificación del extracto, la adición de adyuvantes, la vía de administración y la dosis acumulada. Solo datos clínicos convincentesdeben servir para la evaluación específica de cada producto o como base para la comparación entre productos. (AU)
Subject(s)


Full text: Available Collection: National databases / Spain Database: IBECS Main subject: Allergens / Adjuvants, Immunologic / Desensitization, Immunologic / Hypersensitivity Limits: Humans Language: English Journal: J. investig. allergol. clin. immunol Year: 2022 Document type: Article Institution/Affiliation country: Allergy Therapeutics (UK) Ltd/United Kingdom / Allergy Therapeutics Ibérica/Spain / Center for Rhinology and Allergy/Germany / Centro Studi Allergie ETS/Italy / Hospital Clinic/Spain / Medical University of Vienna/Austria / Technical University of Dresden/Germany / University Medical Center Tübingen/Germany / University of Santiago de Compostela/Spain / University of Zurich/Switzerland

Full text: Available Collection: National databases / Spain Database: IBECS Main subject: Allergens / Adjuvants, Immunologic / Desensitization, Immunologic / Hypersensitivity Limits: Humans Language: English Journal: J. investig. allergol. clin. immunol Year: 2022 Document type: Article Institution/Affiliation country: Allergy Therapeutics (UK) Ltd/United Kingdom / Allergy Therapeutics Ibérica/Spain / Center for Rhinology and Allergy/Germany / Centro Studi Allergie ETS/Italy / Hospital Clinic/Spain / Medical University of Vienna/Austria / Technical University of Dresden/Germany / University Medical Center Tübingen/Germany / University of Santiago de Compostela/Spain / University of Zurich/Switzerland
...