House Dust Mite SLIT Safe in Children With Allergic Asthma: Study
A phase 3 study found that the SQ house dust mite sublingual immunotherapy (SLIT) tablet was well tolerated in children aged 5-7 years, with most adverse events being mild or moderate. However, reductions in asthma exacerbations during the COVID-19 pandemic affected the study’s ability to meet its primary endpoint.
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.
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.
Reference:
Roberts, G., Just, J., Nolte, H., Hels, O.H., Emeryk, A. and Vidal, C. (2025), SQ House Dust Mite Sublingual Immunotherapy Tablet in Children With Allergic Asthma: A Randomised Phase III Trial. Allergy, 80: 3401-3411. https://doi.org/10.1111/all.70073
