Safety of a Short Ragweed Allergy Immunotherapy Tablet in Adults With Ragweed-Induced Allergic Rhinoconjunctivitis and Asthma

Abstract

FEBRUARY 2011 AB48 Abstracts S A T U R D A Y 173 Efficacy of Timothy Grass Allergy Immunotherapy Tablet During Peak Grass Pollen Season in North American Children and Adolescents J. Maloney, D. Skoner, H. Nolte, S. Gawchik, M. Blaiss; Merck Research Laboratories, Kenilworth, NJ, Drexel University College of Medicine, Philadelphia, PA, Asthma and Allergy Associates, Upland, PA, University of Tennessee Health Science Center, Memphis, TN. RATIONALE: Children with allergic rhinoconjunctivitis (ARC) may experience discomfort and activity limitations, especially during peak grass pollen season (pGPS) when symptoms are the most severe. Efficacy of Timothy grass allergy immunotherapy tablets (grass AIT) during pGPS was evaluated in a randomized, double-blind efficacy/safety trial in North American children/adolescents. METHODS: 344 subjects (5-17y) with grass pollen-induced ARC with/ without asthma received once-daily 2800 BAU-standardized grass AIT (oral lyophilisate, Phleum pratense, 75,000 SQ-T, ;15mg Phl p 5) or placebo amedian of 16 weeks before and duringGPS 2009. pGPSwas defined as the 15-consecutive-day period with the highest moving average pollen count. The daily symptom score (DSS), daily medication score (DMS), total combined score (TCS5sum of DSS andDMS), and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scores (pediatric and adolescent) were assessed. Safetywasmonitored through adverse event (AE) reporting. RESULTS: 89% of subjects were multisensitized. Mean pollen counts (grains/m/d) were: GPS528, pGPS548. Relative to placebo, improvements in TCS, DSS, DMS, and RQLQ with grass AIT were numerically greater during pGPS (31%, P _5 years with Timothy (and other cross-reactive Festucoideae) grass pollen-induced ARC with safe, effective symptom relief.