A 300°IR sublingual tablet is an effective, safe treatment for house-dust-mite-induced allergic rhinitis: an international, double-blind, placebo-controlled, randomized Phase III clinical trial

ABSTRACT Background Allergic rhinitis (AR) induced by house dust mites (HDMs) is a highly prevalent but often underdiagnosed and undertreated/untreated chronic disease. It often has a negative impact on sleep, work, leisure activities, and health-related quality of life. Allergen immunotherapy is a proven, safe treatment for respiratory allergies. Objective To assess the efficacy and safety of a 300 index of reactivity (IR) sublingual tablet formulation of Dermatophagoides pteronyssinus:Dermatophagoides farinae 1:1 extract in adolescents (aged ≥12) and adults with moderate-to-severe HDM-induced AR. Methods In a Phase III, international, double-blind, placebo-controlled, randomized clinical trial, participants received approximately 12 months of treatment with placebo or the 300°IR tablet. The primary endpoint was the average total combined score (aTCS) during 4 weeks at the end of the treatment period. Results 1,607 participants were randomized, and 1,476 (including 555 (37.6%) with concomitant mild controlled asthma at inclusion) comprised the full analysis set. Over the primary evaluation period, the least squares mean aTCS in the 300°IR group (3.62) was significantly lower (p Conclusions The 300°IR sublingual HDM tablet is an effective, safe treatment for HDM-induced AR. (NCT02443805, EudraCT 2014-004223-46) Clinical Implications A 300 index of reactivity sublingual tablet formulation of Dermatophagoides pteronyssinus:Dermatophagoides farinae extract is a safe, effective treatment for moderate-to-severe house-dust-mite-induced allergic rhinitis.