SQ House Dust Mite Sublingual Immunotherapy Tablet in Children With Allergic Asthma: A Randomised Phase III Trial

Allergy. 2025 Dec;80(12):3401-3411. doi: 10.1111/all.70073. Epub 2025 Oct 9.

Abstract

Background: In children, house dust mite (HDM) sensitisation is a contributing factor for developing allergic asthma. HDM allergen immunotherapy has demonstrated efficacy and safety in adults with allergic asthma; however, evidence for its use in children is limited. MT-11 evaluated the efficacy and safety of the SQ HDM sublingual immunotherapy (SLIT) tablet in children (5-17 years) with HDM allergic asthma.

Methods: This phase III, randomised, double-blind, placebo-controlled trial randomised 533 children with a recent history of asthma exacerbations, despite treatment with inhaled corticosteroids and/or long-acting beta-agonists, to daily treatment with SQ HDM SLIT-tablet or placebo for 24-30 months. The primary endpoint was the annualised rate of clinically relevant asthma exacerbations. Adverse events (AEs) were reported throughout the trial.

Results: The rate ratio for the annualised rate of clinically relevant asthma exacerbations was 0.89 (95% CI: 0.60, 1.31), in favour of the SQ HDM-SLIT tablet; superiority over placebo was not established. Most treatment-related AEs (TRAEs) were of mild or moderate severity, and few subjects discontinued due to TRAEs (< 2%). The most common TRAEs were local application site reactions (oral pruritus, throat irritation, ear pruritus, and upper abdominal pain). There was no increased incidence of asthma-related events, and no anaphylaxis or adrenaline use in the SQ HDM SLIT-tablet group.

Conclusion: As a result of the coronavirus disease 2019 pandemic, asthma exacerbation rates were much lower than expected, contributing to the primary endpoint not being met. The SQ HDM SLIT-tablet was well tolerated in a paediatric population with inadequately controlled HDM allergic asthma.

Trial registration: Clinicaltrials.gov identifier: NCT03654976; EudraCT number: 2016-004363-39.

Keywords: allergen immunotherapy; allergic asthma; children; house dust mite; sublingual immunotherapy.

Publication types

  • Clinical Trial, Phase III
  • Randomized Controlled Trial
  • Multicenter Study

MeSH terms

  • Adolescent
  • Allergens* / administration & dosage
  • Allergens* / immunology
  • Animals
  • Antigens, Dermatophagoides* / administration & dosage
  • Antigens, Dermatophagoides* / immunology
  • Asthma* / diagnosis
  • Asthma* / immunology
  • Asthma* / therapy
  • Child
  • Child, Preschool
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Pyroglyphidae* / immunology
  • Sublingual Immunotherapy* / adverse effects
  • Sublingual Immunotherapy* / methods
  • Tablets
  • Treatment Outcome

Substances

  • Tablets
  • Antigens, Dermatophagoides
  • Allergens

Associated data

  • ClinicalTrials.gov/NCT03654976

Grants and funding