ASCIA‐P50: SAFETY OF HOUSE DUST MITE SUBLINGUAL TABLET FOR THE TREATMENT OF HOUSE DUST MITE‐ASSOCIATED ALLERGIC RHINITIS IN ADULTS AND PEDIATRIC SUBJECTS WITH INTERMITTENT ASTHMA

Abstract

Background: Asthma is frequently associated in subjects with house dust mite (HDM)‐induced allergic rhinitis (AR). Here we present the safety experience of the HDM sublingual tablet across the rhinitis clinical program by asthma status. Methods: Subjects with medically confirmed HDM‐associated AR were included in one of four double‐blind studies (including one environmental exposure chamber study) conducted worldwide. Those with intermittent asthma controlled with GINA Step 1 treatment could participate. Participants were randomized to receive active treatment or placebo once daily for up to one year. Adverse events (AEs) pooled from the studies were analyzed descriptively. Results: The analysis included 1,126 adults (18‐61 years), 345 adolescents (12‐17 years) and 246 children (5‐11 years). Of these, 215 (19%) adults, 150 (43%) adolescents and 159 (65%) children had intermittent asthma at baseline. Drug‐related AEs (ADRs) were reported with similar incidences in actively‐treated subjects with and without asthma (adults: 72% vs. 65%; adolescents: 50% vs. 56%; children: 33% each) and mostly occurred within the first month of treatment (adults: 92%; adolescents: 88%; children: 91%). The incidences of AEs leading to withdrawal, mostly application‐site reactions, in asthma vs. no asthma subsets were 5.0% vs.4.1% (adults), 10.3% vs. 2.1% (adolescents) and 5.7% vs. 5.0% (children). Conclusion: Treatment with HDM sublingual tablets had a similar safety profile in HDM allergic population whether they had or not intermittent asthma. (Table Presented).