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

Background Allergic rhinitis induced by house dust mites (HDMs) is a highly prevalent but often underdiagnosed and undertreated/untreated chronic disease. It has negative impact on sleep, work, leisure activities, health-related quality of life. Allergen immunotherapy proven, safe treatment for respiratory allergies. Objective We sought to assess the efficacy safety 300 index reactivity (IR) sublingual tablet formulation Dermatophagoides pteronyssinus:Dermatophagoides farinae 1:1 extract in adolescents (aged ≥12) adults with moderate severe HDM-induced allergic rhinitis. Methods In phase III, international, double-blind, placebo-controlled, randomized clinical trial, participants received approximately 12 months placebo or IR tablet. The primary end point was average total combined score during 4 weeks at period. Results A 1607 were randomized, 1476 (including 555 [37.6%] concomitant mild controlled asthma inclusion) comprised full analysis set. Over evaluation period, least squares mean group (3.62) significantly lower (P < .0001) than (4.35), relative difference −16.9% (95% CI, −24.0% −9.2%). All prespecified secondary points consistently improved group, placebo. generally well tolerated. Treatment-related adverse events (mainly local reactions) reported 51.0% patients 14.9% group. Conclusions HDM an effective,