Methods: Subjects (5-64 years) with medically confirmed HDM-associated AR were randomized to receive placebo or STG320 at doses from 100IR to 1,500IR. Adverse events were monitored and analyzed descriptively.
Results: 2,407 subjects (1,718 adults, 443 adolescents, 246 children) comprised the Safety Set including 627 (26%) with intermittent asthma at enrollment. 1,571 participants received at least one dose of active treatment and 836 received placebo. 64% of actively-treated subjects and 20% of placebo-recipients reported treatment-emergent adverse events (TEAEs) suspected to be drug-related. These were mostly consistent with mild or moderate application-site reactions [e.g., throat irritation (23%), oral pruritus (17%), mouth edema (14%), ear pruritus (12%)] and mainly reported over the initial 4 weeks. Percentages of subjects with drug-related TEAEs were similar in those with and without asthma in active (59% and 66%) and placebo (19% and 20%) groups. Four subjects reported serious drug-related TEAEs (3 active: eczema, pharyngeal edema and dyspnea, and one placebo: urticaria). 123 (8%) and 24 (3%) subjects in active and placebo groups, respectively, discontinued mainly as a result of application-site reactions (e.g., mouth or lip edema). There were no reports of anaphylaxis and no epinephrine use.
Conclusions: Pooled safety data from the rhinitis program demonstrate the favorable safety profile of HDM sublingual tablets in subjects receiving any dose of active treatment.