Data Material

This is the first study to demonstrate the efficacy and safety of timothy grass AIT treatment in a predominantly multisensitized North American pediatric population. In this phase 3, double-blind placebo-controlled trial, 345 subjects between the age of 5 and 17 years of age were randomized to grass SLIT-t treatment (2,800 BAU,75,000 standardized quality tablet, approximately 15 μg of Phl p 5) or placebo approximately 16 weeks before the 2009 grass pollen season (GPS). The primary endpoint was the total combined score (TCS) of the daily symptom score (DSS) and daily medication score (DMS) for the entire GPS. TCS, DSS and DMS versus placebo improved 26%, 25% and 81% and Phl p 5–specific IgG4 and IgE-blocking factor levels were significantly higher at the peak and end of the GPS. It was concluded that the use of timothy grass SLIT-t treatment effectively treats timothy grass (cross-reactive with Festucoideae grasses) pollen–induced ARC in North American children 5 years and older.