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In children (aged 5-11 years) suffering from allergic rhinitis/rhinoconjunctivitis, house dust mite sublingual immunotherapy tablet is safe and well-tolerated.
In patients aged 12-65 years, the house dust mite (HDM) sublingual immunotherapy (SLIT)-tablet is an approved treatment for allergic rhinitis/rhinoconjunctivitis (AR/C). A phase 3 randomized trial investigated its safety in 1458 HDM AR/C-affected kids (aged 5-11 years), with or without asthma.
Participants received either a daily HDM SLIT tablet or a placebo for approximately 52 weeks. The trial focused on assessing the safety of the treatment, including treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), local application site reactions, and any events of special interest. As found, solicited adverse events accounted for 76% of all TEAEs. The rate of TRAEs was higher in the SLIT-tablet group (75%) when compared to placebo (54%).
Ear pruritus, throat irritation, and oral pruritus were the most frequently reported TRAEs. The median time to onset for these TRAEs was between days 1.5 and 4 of treatment, with a median recurrence occurring after 1-2 days. Over 99% of TRAEs were mild-to-moderate in severity, and the discontinuation rate due to TRAEs was low (1.8% for the HDM SLIT-tablet group and 1.0% for the placebo group).
No cases of anaphylaxis, epinephrine administration, serious TRAEs, or TEAEs related to eosinophilic esophagitis were reported. In the HDM SLIT-tablet group, 2 treatment-linked systemic reactions occurred. These reactions were mild, non-serious, and resolved with antihistamines. Thus, HDM SLIT-tablet is well-tolerated in children with AR/C, with a safety profile similar to that observed in adolescents and adults.
Annals of Allergy, Asthma & Immunology
Safety of the house dust mite sublingual immunotherapy tablet in a pediatric allergic rhinitis/rhinoconjunctivitis trial
D. Caimmi et al.
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