title: House dust mite sublingual immunotherapy: results of a US trial.
abstract: BACKGROUND
  Few trials of sublingual immunotherapy (SLIT) in the United States have been reported.
  
  
  OBJECTIVE
  This randomized, placebo-controlled feasibility SLIT study compared the safety and physiologic effects of high- versus low-dose Dermatophagoides farinae vaccine.
  
  
  METHODS
  Thirty-one D farinae-sensitive adults with allergic rhinitis with or without mild intermittent asthma were eligible for randomization to high-dose maintenance vaccine (n = 10, 4200 allergen units [approximately 70 μg of Der f 1/d]), low-dose maintenance vaccine (n = 10; 60 allergen units [approximately 1 μg of Der f 1/d]), or placebo (n = 11) over 12 to 18 months. Medication-symptom scores and adverse events were monitored, serum D farinae-specific IgE and IgG4 levels were measured, and bronchial reactivity to D farinae was determined at baseline and 6-month intervals.
  
  
  RESULTS
  Of the 31 randomized subjects, 6 withdrew because of non-treatment-ascribed events. Four withdrew because of treatment-ascribed effects: high-dose group, 1 of 10 (gastrointestinal symptoms); low-dose group, 1 of 10 (gastrointestinal symptoms); and placebo group, 2 of 11 (headache and increased nasal symptoms). Thus 21 subjects completed the study: high-dose group, 9; low-dose group, 7; and placebo group, 5. Eleven of the 21 subjects experienced mild-to-moderate gastrointestinal symptoms, throat irritation, or both (high-dose group, 5/9; low-dose group, 4/7; and placebo group, 2/5). No severe systemic reactions were noted. No differences in symptom-medication scores were found. High-dose SLIT increased the bronchial threshold to allergen challenge and increased serum D farinae-specific IgG4 levels, whereas low-dose SLIT and placebo had no significant effect.
  
  
  CONCLUSIONS
  High-dose D farinae SLIT was generally tolerable, increased serum D farinae-specific IgG4 levels, and improved the bronchial threshold to allergen challenge. Larger US trials are warranted.
authors.affiliation: Section of Allergy, Immunology, Pulmonary, Critical Care and Sleep Medicine, University of Wisconsin-Madison, Madison, WI, USA. rkb@medicine.wisc.edu
authors.forename: Robert K
authors.initials: RK
authors.lastname: Bush
authors.forename: Cheri
authors.initials: C
authors.lastname: Swenson
authors.forename: Beth
authors.initials: B
authors.lastname: Fahlberg
authors.forename: Michael D
authors.initials: MD
authors.lastname: Evans
authors.forename: Robert
authors.initials: R
authors.lastname: Esch
authors.forename: Mary
authors.initials: M
authors.lastname: Morris
authors.forename: William W
authors.initials: WW
authors.lastname: Busse
mesh_terms: D000286:Administration, Sublingual; D000818:Animals; D039741:Antigens, Dermatophagoides / Q000008:administration & dosage* / Q000009:adverse effects; D060829:Arthropod Proteins; D003546:Cysteine Endopeptidases; D003888:Desensitization, Immunologic / Q000009:adverse effects* / Q000379:methods*; D004311:Double-Blind Method; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007073:Immunoglobulin E / Q000097:blood; D007074:Immunoglobulin G / Q000097:blood; D008297:Male; D039981:Pyroglyphidae / Q000276:immunology*; D012221:Rhinitis, Allergic, Perennial / Q000517:prevention & control*; D016896:Treatment Outcome; D014481:United States
chemical_list: D039741:Antigens, Dermatophagoides; D060829:Arthropod Proteins; D007074:Immunoglobulin G; D007073:Immunoglobulin E; D003546:Cysteine Endopeptidases; C451159:Dermatophagoides farinae antigen f 1