Data Material

This clinical trial was a Phase 3, open-label, single-arm, 28-day safety trial of daily HDM SLIT-t (12 SQ-HDM dose) in European adolescents 12-17 years of age. This data was then compared with existing adolescent subpopulation data from previously described Phase 3 trials in North America (P001) or Japan (TO-203-3-2). The primary endpoint was at least one treatment-emergent adverse event (TEAE).The percentage of the MT-18 cohort (n=253), P001 (n=189), and TO-203-3-2 (n=206) treated with the 12 SQ-HDM reporting any TEAE was 88%, 95%, and 93%, respectively. The percentage reporting any treatment-related adverse event (TRAE) was 86%, 93%, and 66%, respectively. TRAEs were most commonly local application site reactions, mild in intensity and were typically experienced within the first 1-2 days of treatment. The authors concluded that the HDM SLIT-t was safe and well-tolerated in European, North American, and Japanese adolescents.