Efficacy of 300IR 5-Grass Pollen Sublingual Tablet in the Treatment of Rhinitis Symptoms in Polysensitized Subjects with Grass Pollen-Induced Allergic Rhinoconjunctivitis
Saturday, March 5, 2016
South Exhibit Hall H (Convention Center)
Robert K. Zeldin, MD, Yann Amistani, MSc, Josiane Cognet-Sicé, PharmD, Kathy Abiteboul, PharmD
Rationale: The efficacy of 300IR 5-grass pollen sublingual tablet (Oralair) when administered to subjects with grass pollen-induced allergic rhinoconjunctivitis (ARC) according to a 4-month pre-seasonal and co-seasonal regimen has been consistently demonstrated across the development program. Here we present the efficacy results for individual rhinitis symptoms in polysensitized subjects.

Methods: Subjects with medically confirmed grass pollen-induced ARC for at least 2 years were enrolled in one of 4 natural field studies. All participants underwent prick skin testing to 5-grass mix or timothy and a panel of geographically relevant aeroallergens. Those who had a positive test to 5-grass/timothy and at least one other allergen were considered polysensitized. Each day, subjects self-scored each of their rhinitis symptoms (sneezing, rhinorrhea, nasal pruritus, nasal congestion) on a scale from 0 (none) to 3 (severe). The individual symptom scores and the Rhinitis Total Symptom Score (the sum of the four individual symptom scores) were analyzed descriptively.

Results: Data from 891 polysensitized subjects, corresponding to 65% of the studied population, were analyzed. The means of each of the individual symptom scores in the 300IR group (n=427) were significantly lower than in the placebo group (n=464) with relative differences from placebo of -15% (sneezing), -19% (rhinorrhea), -22% (nasal pruritus) and ­-24% (nasal congestion). The Rhinitis Total Symptom Score relative mean difference from placebo was -20%.

Conclusions: Oralair effectively reduced all rhinitis symptoms in polysensitized subjects with grass pollen-induced rhinoconjunctivitis.