Effective treatment of house dust mite-induced allergic rhinitis with 2 doses of the SQ HDM SLIT-tablet: Results from a randomized, double-blind, placebo-controlled phase III trial

J Allergy Clin Immunol. 2016 Feb;137(2):444-451.e8. doi: 10.1016/j.jaci.2015.06.036. Epub 2015 Aug 17.

Abstract

Background: The SQ HDM SLIT-tablet (ALK) has been developed for treatment of house dust mite (HDM)-induced respiratory allergic disease.

Objective: This trial investigated the efficacy and safety of the SQ HDM SLIT-tablet in adults with moderate-to-severe HDM-induced allergic rhinitis (AR).

Methods: The trial was a randomized, double-blind, placebo-controlled phase III trial conducted in 12 European countries including 992 adults with moderate-to-severe HDM-induced AR despite treatment with pharmacotherapy. Subjects were randomized 1:1:1 to 1 year of daily treatment with placebo, 6 SQ-HDM, or 12 SQ-HDM. The primary end point was the total combined rhinitis score (ie, the sum of rhinitis symptom and medication scores) during the efficacy assessment period (approximately the last 8 weeks of the treatment period). Key secondary end points were rhinitis symptoms, medication scores, quality of life, and the combined rhinoconjunctivitis score.

Results: Analysis of the primary end point (observed data) demonstrated absolute reductions in total combined rhinitis score of 1.18 (P = .002) and 1.22 (P = .001) compared with placebo for 6 SQ-HDM and 12 SQ-HDM, respectively. The statistically significant treatment effect was evident from 14 weeks of treatment onward. For all key secondary end points, efficacy was confirmed for 12 SQ-HDM, with statistically significant reductions of rhinitis symptoms and medication scores, improved quality of life, and a reduced combined rhinoconjunctivitis score in the efficacy assessment period compared with placebo. The treatment was well tolerated.

Conclusion: The trial confirmed the efficacy and favorable safety profile of both 6 SQ-HDM and 12 SQ-HDM in adults with HDM-induced AR. The treatment effect was present from 14 weeks of treatment onward.

Keywords: Allergy immunotherapy; Rhinitis Quality of Life Questionnaire; allergen immunotherapy; allergic rhinitis; allergy; house dust mite; rhinoconjunctivitis; sublingual immunotherapy; sublingual immunotherapy tablet; total combined rhinitis score.

Publication types

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

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Allergens / administration & dosage
  • Allergens / immunology*
  • Animals
  • Antigens, Dermatophagoides / immunology*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Pyroglyphidae / immunology*
  • Rhinitis, Allergic / immunology*
  • Rhinitis, Allergic / therapy*
  • Risk Factors
  • Sublingual Immunotherapy* / methods
  • Time Factors
  • Treatment Outcome
  • Young Adult

Substances

  • Allergens
  • Antigens, Dermatophagoides