Efficacy of Timothy Grass Allergy Immunotherapy Tablet During Peak Grass Pollen Season in North American Adults

Abstract

RATIONALE: Patients with allergic rhinoconjunctivitis (ARC) may need symptom relief most during peak grass pollen season (pGPS). Timothy grass allergy immunotherapy tablet (grass AIT) pGPS efficacy was assessed in a randomized, double-blind study of North American adults with ARC with/without asthma.METHODS: 438 subjects received once-daily 2800 BAU-standardized grass AIT (oral lyophilisate, Phleum pratense, 75,000 SQ-T, ∼15μg Phl p 5) a median of 16 weeks before and throughout GPS. pGPS was defined as the 15-consecutive-day period with the highest moving average pollen count. Daily symptom score (DSS), daily medication score (DMS), total combined score (TCS= DSS+DMS), and Rhinoconjunctivitis Quality of Life Questionnaire with standardized activities (RQLQ[S]) score were assessed. Adverse events were monitored for safety.RESULTS: 85% of subjects were multisensitized. Mean pollen counts (grains/m3/d) were: GPS=27, pGPS=48. During pGPS, observed changes in TCS, DSS, DMS, and RQLQ[S] for grass AIT subjects vs placebo were: 21% (P=0.01), 21% (P=0.003), 22% (P=0.21), and 27% (P=0.01). During entire GPS, observed changes in TCS, DSS, DMS, and RQLQ[S] for grass AIT subjects vs placebo were: 20% (P=0.005), 18% (P=0.02), 26% (P=0.08), and 17% (P=0.02). Grass AIT treatment was well-tolerated, with no systemic allergic reactions, anaphylactic shocks, or respiratory compromise reported.CONCLUSIONS: The effectiveness of Timothy grass AIT during pGPS, when pollen counts are highest and symptoms may be most severe, is comparable with or improved over that of the entire GPS. Grass AIT may provide a safe and effective new modality for treating patients with Timothy (and other cross-reactive Festucoideae) grass pollen-induced ARC. RATIONALE: Patients with allergic rhinoconjunctivitis (ARC) may need symptom relief most during peak grass pollen season (pGPS). Timothy grass allergy immunotherapy tablet (grass AIT) pGPS efficacy was assessed in a randomized, double-blind study of North American adults with ARC with/without asthma. METHODS: 438 subjects received once-daily 2800 BAU-standardized grass AIT (oral lyophilisate, Phleum pratense, 75,000 SQ-T, ∼15μg Phl p 5) a median of 16 weeks before and throughout GPS. pGPS was defined as the 15-consecutive-day period with the highest moving average pollen count. Daily symptom score (DSS), daily medication score (DMS), total combined score (TCS= DSS+DMS), and Rhinoconjunctivitis Quality of Life Questionnaire with standardized activities (RQLQ[S]) score were assessed. Adverse events were monitored for safety. RESULTS: 85% of subjects were multisensitized. Mean pollen counts (grains/m3/d) were: GPS=27, pGPS=48. During pGPS, observed changes in TCS, DSS, DMS, and RQLQ[S] for grass AIT subjects vs placebo were: 21% (P=0.01), 21% (P=0.003), 22% (P=0.21), and 27% (P=0.01). During entire GPS, observed changes in TCS, DSS, DMS, and RQLQ[S] for grass AIT subjects vs placebo were: 20% (P=0.005), 18% (P=0.02), 26% (P=0.08), and 17% (P=0.02). Grass AIT treatment was well-tolerated, with no systemic allergic reactions, anaphylactic shocks, or respiratory compromise reported. CONCLUSIONS: The effectiveness of Timothy grass AIT during pGPS, when pollen counts are highest and symptoms may be most severe, is comparable with or improved over that of the entire GPS. Grass AIT may provide a safe and effective new modality for treating patients with Timothy (and other cross-reactive Festucoideae) grass pollen-induced ARC.