Display Settings:

Format

Send to:

Choose Destination
J Allergy Clin Immunol. 2014 Jun;133(6):1608-14.e6. doi: 10.1016/j.jaci.2013.11.012. Epub 2013 Dec 31.

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

Author information

  • 1Allergy-Centre-Charité, Charité-Universitätsmedizin Berlin, Berlin, Germany. Electronic address: karlchristianbergmann@googlemail.com.
  • 2Allergology Department, CHU Montpellier, Montpellier, France.
  • 3Allergy-Centre-Charité, Charité-Universitätsmedizin Berlin, Berlin, Germany.
  • 4Academic Medical Centre, Otorhinolaryngology, Amsterdam, The Netherlands.
  • 5Allergology Department, Hospital Universitario de Gran Canaria Dr Negrin, Las Palmas de Gran Canaria, Spain.
  • 6Department of Allergy, Compleio Hospitalario de Navarra, Pamplona, Spain.
  • 7Stallergenes S.A., Antony, France.

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.

Copyright © 2013 American Academy of Allergy, Asthma & Immunology. Published by Mosby, Inc. All rights reserved.

KEYWORDS:

Allergic rhinitis; double-blind; house dust mite; placebo-controlled; sublingual immunotherapy tablets

PMID:
24388010
[PubMed - indexed for MEDLINE]
PubMed Commons home

PubMed Commons

0 comments
How to join PubMed Commons

    Supplemental Content

    Full text links

    Icon for Elsevier Science
    Loading ...
    Write to the Help Desk