Pooled efficacy and safety data for house dust mite sublingual immunotherapy tablets in adolescents

Background House dust mite (HDM) respiratory allergy is a common and burdensome disease in children and adolescents. There are few HDM allergy immunotherapy trials in children with perennial allergic rhinitis. This post hoc analysis used pooled data to evaluate efficacy and safety of the SQ HDM sublingual immunotherapy (SLIT) tablet in adolescents (12-17 years). Methods In 2 double-blind, placebo-controlled trials conducted in North America and Japan, respectively, subjects aged 12+ years with HDM allergic rhinitis were randomized to up to one year of treatment. The primary endpoint in both trials was the average total combined rhinitis score (TCRS) during the last 8 weeks of treatment in the active group compared to placebo. Data from subjects aged 12–17 years were pooled (N=395). Results In the pooled adolescent subpopulation, average TCRS improved 22% with 12 SQ-HDM versus placebo (absolute treatment difference of 1.04; p<0.01). Rhinitis daily symptom score (DSS), conjunctivitis DSS, and rhinitis daily medication score (DMS) were also significantly improved versus placebo in the pooled adolescent subpopulation (all p<0.05). There were no new safety signals for adolescents. The frequency of adverse events were similar in adolescents and adults with the majority being mild application site related events. Conclusions Treatment with 12 SQ-HDM appears to be effective and well-tolerated in adolescents with HDM allergic rhinitis. This article is protected by copyright. All rights reserved.