Efficacy and safety of D. pteronyssinus immunotherapy in local allergic rhinitis: a double-blind placebo-controlled clinical trial

Allergy. 2016 Jul;71(7):1057-61. doi: 10.1111/all.12889. Epub 2016 Apr 13.

Abstract

The effects of allergen immunotherapy (AIT) on local allergic rhinitis (LAR) are largely unknown. We conducted the first randomized, double-blind, placebo-controlled (DBPC), phase II trial of D. pteronyssinus (DP) subcutaneous AIT (DP-AIT) on LAR (clinicaltrials.gov identifier: NCT02123316). Thirty-six LAR patients received Pangramin PLUS DP or placebo for 24 months. The primary endpoints were symptoms, medication scores, and medication-free days. The secondary included skin test, serum specific IgE and IgG4, nasal allergen provocation test (NAPT), and adverse events. AIT-DP produced significant improvements in both primary and secondary endpoints vs placebo. After 12 months of AIT-DP, we detected a significant and marked increase in allergen tolerance with negative NAPT in 50% of patients, and significant increases of serum sIgG4. Immunotherapy was well tolerated; no systemic reactions were reported. This study demonstrated that AIT-DP is a safe and clinically effective treatment for LAR, confirming that LAR is a new indication for AIT.

Keywords: allergen immunotherapy; clinical effect; house dust mite; immunological response; local allergic rhinitis.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Allergens / administration & dosage
  • Allergens / immunology*
  • Animals
  • Antigens, Dermatophagoides / administration & dosage
  • Antigens, Dermatophagoides / immunology*
  • Dermatophagoides pteronyssinus / immunology*
  • Desensitization, Immunologic* / methods
  • Humans
  • Rhinitis, Allergic / immunology*
  • Rhinitis, Allergic / therapy*
  • Treatment Outcome

Substances

  • Allergens
  • Antigens, Dermatophagoides

Associated data

  • ClinicalTrials.gov/NCT02123316