title: Dose-Dependent Immunological Responses after a 6-Month Course of Sublingual House Dust Mite Immunotherapy in Patients with Allergic Rhinitis.
abstract: BACKGROUND
  House dust mite (HDM) immunotherapy has proven efficacy in treating allergic rhinitis (AR) symptoms. This trial evaluated the dose-response relationship of SLIToneULTRA® HDM mix based on immunological parameters and safety in subjects with moderate-to-severe HDM AR not controlled by symptomatic medication.
  
  
  METHODS
  A randomized, parallel-group, open-label, clinical trial compared 50/150/300 standard reactivity unit (SRU) doses of SLIToneULTRA® HDM mix for 6 months. Subjects had moderate-to-severe HDM AR, positive skin prick and IgE against Dermatophagoides pteronyssinus/Dermatophagoides farinae (DP/DF). The primary end point was change from baseline in the IgE-blocking factor against DP after 6 months. Secondary end points measured changes in the IgE-blocking factor for DP at 3 months and for DF at 3 and 6 months, and in IgG4 and specific IgE to DP/DF after 3 and 6 months. Tolerability was assessed through the evaluation of all adverse events (AEs).
  
  
  RESULTS
  A total of 219 subjects were randomized and 196 completed the trial. Dose effect was significant on DP IgE-BF after 6 months (p = 0.018). The change in the DP IgE-blocking factor at a 300-SRU dose was higher than at other doses after 3 (p = 0.008) and 6 (p = 0005) months of treatment. Similar changes were observed for IgG4 and allergen-specific IgE. The number of AEs increased with the dose and were mild-to-moderate, with no severe treatment-related AEs reported. The most frequent AEs were oral/tongue pruritus, mouth oedema and abdominal upper pain.
  
  
  CONCLUSIONS
  Data showed a dose-response for immunological markers and safety with a better immunological response for 300 SRU. The highest dose (300 SRU daily) was considered as the optimal maintenance dose.
authors.affiliation: Department of Respiratory Diseases, Larrey Hospital, Toulouse, France.
authors.forename: Alain
authors.initials: A
authors.lastname: Didier
authors.forename: Paloma
authors.initials: P
authors.lastname: Campo
authors.forename: Francisco
authors.initials: F
authors.lastname: Moreno
authors.forename: François
authors.initials: F
authors.lastname: Durand-Perdriel
authors.forename: Alicia
authors.initials: A
authors.lastname: Marin
authors.forename: Antoine
authors.initials: A
authors.lastname: Chartier
mesh_terms: D000328:Adult; D000818:Animals; D039741:Antigens, Dermatophagoides / Q000276:immunology*; D003888:Desensitization, Immunologic / Q000009:adverse effects; D004306:Dose-Response Relationship, Immunologic; D005260:Female; D006801:Humans; D007073:Immunoglobulin E / Q000276:immunology; D008297:Male; D065631:Rhinitis, Allergic / Q000276:immunology / Q000628:therapy*
chemical_list: D039741:Antigens, Dermatophagoides; D007073:Immunoglobulin E