ASCIA‐P49: SAFETY OF 300IR SUBLINGUAL TABLET OF HOUSE DUST MITE ALLERGEN EXTRACTS IN ADOLESCENTS WITH HOUSE DUST MITE‐ASSOCIATED ALLERGIC RHINITIS

Abstract

Safety of house dust mite (HDM) sublingual tablets for the treatment of HDM-associated allergic rhinitis (AR) has been assessed across the clinical program. Here we present pooled safety data in adolescents treated with the 300IR dose. Adolescents (12–17 years) with medically confirmed HDM-associated AR were randomized in two Phase II/III double-blind studies conducted in Europe and Japan to receive a 300IR HDM tablet or placebo once daily for one year. Adverse events (AEs) were monitored throughout the studies and analyzed descriptively. 345 adolescents (300IR=173, Placebo = 172) comprised the Safety Set including 150 (43%) subjects with intermittent asthma at enrollment. The most commonly reported AEs during active treatment in the adolescents were mild or moderate application-site reactions such as throat irritation (13.9%), oral pruritus (9.8%) or mouth edema (8.7%). They occurred during the first day of treatment in nearly 20% of subjects and within the first month in about 50% of them. None of the serious AEs reported in 11 subjects (300IR=5, Placebo = 6) were considered drug-related. 18 subjects [300IR=12 (6.9%) and Placebo = 6 (3.5%)] withdrew due to an AE, mainly as a result of application-site reactions (e.g., upper abdominal pain, tongue edema). There were no reports of anaphylaxis and no use of epinephrine. Percentages of adolescents reporting at least one AE during active treatment or those reporting adverse reactions (ADRs) were similar in subjects with or without asthma [with asthma: 77% (AEs) and 50% (ADRs); without asthma: 78% (AEs) and 56% (ADRs)]. In both asthmatic and non-asthmatic subjects, the most frequent adverse reactions were those reported at the application site and were of similar incidences. A favorable safety profile of 300IR HDM sublingual tablets was demonstrated in adolescents with HDM-induced allergic rhinitis associated or not with intermittent asthma.