Efficacy and safety of the SQ house dust mite sublingual immunotherapy tablet in Japanese adults and adolescents with house dust mite–induced allergic rhinitis

Abstract

The trial confirmed the efficacy and safety profile of the SQ HDM SLIT tablet in Japanese adult and adolescent patients with moderate-to-severe HDM-induced AR. These data support the robust efficacy and safety profile of previously reported European data.

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

“…Both trials have been previously described. 5,6 The trials were conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines.…”

“…Details of symptom and medication scoring have been previously described. 5,6 Rhinitis exacerbation days were defined as days with an allergic rhinitis symptom score of 6, or 5 with one individual symptom scored 3 (ie, implying a symptom that was hard to tolerate and caused interference with activities of daily living and/or sleeping). Mild days were defined as days with no individual symptom scored higher than 1 (ie, the symptom was clearly present but caused minimal awareness and was easily tolerated) and no antihistamine use.…”

“…5,6 No new safety signals were identified in the adolescent subpopulation. More subjects in the active group reported treatment-related AEs; however, the majority were mild in intensity (Table 3).…”

“…SQ HDM SLIT-tablets have demonstrated clinical benefit in adults with HDM allergic rhinitis (with or without conjunctivitis) and HDM allergic asthma. [5][6][7][8][9][10][11] One safety trial conducted in adolescents found that SQ HDM SLIT-tablets were well tolerated. 12 Among trials that evaluated the efficacy and safety of SQ HDM SLITtablet for the treatment of moderate-severe HDM allergic rhinitis, 2 trials included adolescent subpopulations (aged 12-17 years).…”

“…12 Among trials that evaluated the efficacy and safety of SQ HDM SLITtablet for the treatment of moderate-severe HDM allergic rhinitis, 2 trials included adolescent subpopulations (aged 12-17 years). 5,6 The objective of this post hoc analysis was to use pooled data from these 2 previously published trials to evaluate the efficacy and safety of SQ HDM SLIT-tablets in the adolescent subpopulation.…”