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House dust mite sublingual immunotherapy: results of a US trial.

AbstractBACKGROUND:
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.
AuthorsRobert K Bush, Cheri Swenson, Beth Fahlberg, Michael D Evans, Robert Esch, Mary Morris, William W Busse
JournalThe Journal of allergy and clinical immunology (J Allergy Clin Immunol) Vol. 127 Issue 4 Pg. 974-81.e1-7 (Apr 2011) ISSN: 1097-6825 [Electronic] United States
PMID21333346 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural)
CopyrightCopyright © 2011 American Academy of Allergy, Asthma & Immunology. Published by Mosby, Inc. All rights reserved.
Chemical References
  • Antigens, Dermatophagoides
  • Arthropod Proteins
  • Immunoglobulin G
  • Immunoglobulin E
  • Cysteine Endopeptidases
  • Dermatophagoides farinae antigen f 1
Topics
  • Administration, Sublingual
  • Animals
  • Antigens, Dermatophagoides (administration & dosage, adverse effects)
  • Arthropod Proteins
  • Cysteine Endopeptidases
  • Desensitization, Immunologic (adverse effects, methods)
  • Double-Blind Method
  • Feasibility Studies
  • Female
  • Humans
  • Immunoglobulin E (blood)
  • Immunoglobulin G (blood)
  • Male
  • Pyroglyphidae (immunology)
  • Rhinitis, Allergic, Perennial (prevention & control)
  • Treatment Outcome
  • United States

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