Efficacy and safety of sublingual tablets of house dust mite allergen extracts in adults with allergic rhinitis.

Abstract

BACKGROUND:

Preliminary studies have suggested the efficacy of sublingual tablets of house dust mite (HDM) extracts in adults with allergic rhinitis.

OBJECTIVES:

We sought to assess the efficacy and safety of 2 doses of HDM sublingual tablets over 1 treatment year and the subsequent immunotherapy-free year.

METHODS:

Adults with HDM-associated allergic rhinitis were randomized in a double-blind, placebo-controlled study to receive 500 index of reactivity (IR) tablets, 300IR tablets, or placebo administered once daily for 1 year and were followed for the subsequent year. The primary efficacy variable was the Average Adjusted Symptom Score over the year 1 primary period (ie, October 1 to December 31). Symptoms and rescue medication scores, onset of action, patient-reported outcomes, and safety were secondary variables. The same end points were evaluated during the immunotherapy-free year. The primary efficacy end point was analyzed by using analysis of covariance.

RESULTS:

Five hundred nine participants were randomized, and 427 continued in the immunotherapy-free year. Both the 500IR and 300IR HDM sublingual tablets significantly reduced mean Average Adjusted Symptom Scores compared with placebo by -20.2% (P = .0066) and -17.9% (P = .0150), respectively. Efficacy of both doses was maintained during the treatment-free follow-up phase. The onset of action was at 4 months. Participants' global evaluation of treatment success was significantly higher in the 500IR and 300IR groups compared with the placebo group (P = .0206 and P = .0001, respectively). Adverse events were generally application-site reactions. There were no reports of anaphylaxis.

CONCLUSIONS:

Twelve months of treatment with 500IR and 300IR sublingual tablets of HDM allergen extracts was efficacious and well tolerated. Efficacy was maintained during the treatment-free follow-up year.

• Authors: Karl-Christian Bergmann, Pascal Demoly, Margitta Worm, Wytske J Fokkens, Teresa Carrillo, Ana I Tabar, Hélène Nguyen, Armelle Montagut, Robert K Zeldin
• Journal: The Journal of allergy and clinical immunology (J Allergy Clin Immunol) Vol. 133 Issue 6 Pg. 1608-14.e6 (Jun 2014) ISSN: 1097-6825 [Electronic] United States
• PMID: 24388010 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2013 American Academy of Allergy, Asthma & Immunology. Published by Mosby, Inc. All rights reserved.

Chemical References

• Antigens, Dermatophagoides
• Immunoglobulin G
• Tablets
• Immunoglobulin E

Topics

• Administration, Sublingual
• Adult
• Animals
• Antigens, Dermatophagoides (administration & dosage, immunology)
• Desensitization, Immunologic (adverse effects)
• Female
• Humans
• Immunoglobulin E (blood, immunology)
• Immunoglobulin G (blood, immunology)
• Male
• Pyroglyphidae (immunology)
• Rhinitis, Allergic
• Rhinitis, Allergic, Perennial (immunology, therapy)
• Skin Tests
• Tablets
• Treatment Outcome
• Young Adult