title: European Academy of Allergy and Clinical Immunology task force report on 'dose-response relationship in allergen-specific immunotherapy'.
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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: National Heart and Lung Institute, Imperial College London, UK. m.calderon@imperial.ac.uk
authors.forename: M A
authors.initials: MA
authors.lastname: Calderón
authors.forename: D
authors.initials: D
authors.lastname: Larenas
authors.forename: J
authors.initials: J
authors.lastname: Kleine-Tebbe
authors.forename: L
authors.initials: L
authors.lastname: Jacobsen
authors.forename: G
authors.initials: G
authors.lastname: Passalacqua
authors.forename: P A
authors.initials: PA
authors.lastname: Eng
authors.forename: E M
authors.initials: EM
authors.lastname: Varga
authors.forename: E
authors.initials: E
authors.lastname: Valovirta
authors.forename: C
authors.initials: C
authors.lastname: Moreno
authors.forename: H J
authors.initials: HJ
authors.lastname: Malling
authors.forename: E
authors.initials: E
authors.lastname: Alvarez-Cuesta
authors.forename: S
authors.initials: S
authors.lastname: Durham
authors.forename: P
authors.initials: P
authors.lastname: Demoly
mesh_terms: D000047:Academies and Institutes; D026683:Advisory Committees; D000485:Allergens / Q000008:administration & dosage* / Q000627:therapeutic use; D003888:Desensitization, Immunologic / Q000592:standards; D004306:Dose-Response Relationship, Immunologic; D005060:Europe; D006801:Humans; D006967:Hypersensitivity / Q000628:therapy*; D058028:Research Report; D016896:Treatment Outcome
chemical_list: D000485:Allergens