RATIONALE: Birch, alder, hazel, and oak are members of the birch homologous group based on IgE cr... more RATIONALE: Birch, alder, hazel, and oak are members of the birch homologous group based on IgE cross-reactivity to the major allergen Bet v 1. Treatment effects of tree sublingual immunotherapy (SLIT)tablets containing standardized birch pollen extract in participants with birch pollen-induced allergic rhinitis with or without conjunctivitis (AR/C) were evaluated during alder/hazel and oak pollen seasons. METHODS: In a randomized, multinational, double-blind trial (EudraCT-2015-004821-15), 634 participants (12-65 years) with birch pollen-induced AR/C with or without asthma received daily tree SLITtablets (12 SQ-Bet) or placebo before and during tree pollen season (TPS; start of alder/hazel pollen season through birch pollen season). Rescue medication was allowed. The primary endpoint was the total combined score (TCS; sum of rhinoconjunctivitis daily symptom score [DSS] and daily medication score [DMS]) during birch pollen season. TCS, DSS, and DMS during alder/hazel and oak pollen seasons and the continuous TPS (all days during TPS regardless of pollen counts) were analyzed post-hoc. RESULTS: Relative improvements in TCS with tree SLIT-tablets versus placebo were 39.6%, 29.7%, and 36.0% during birch, alder/hazel, and oak pollen seasons, respectively, and 35.0% for continuous TPS (all p≤0.002). Relative improvements in DSS versus placebo were 36.8%, 26.0%, and 31.6% during birch, alder/hazel, and oak pollen seasons, and 31.6% for continuous TPS (all p≤0.003) and in DMS were 49.2%, 43.8%, 45.9%, and 45.3%, respectively (all p≤0.002). CONCLUSIONS: Improvements with tree SLIT-tablets versus placebo during alder/hazel and oak pollen seasons showed internal consistency across seasons and support the clinical relevance of the immunologic crossreactivity between birch pollen homologous allergens.
RATIONALE: Birch, alder, hazel, and oak are members of the birch homologous group based on IgE cr... more RATIONALE: Birch, alder, hazel, and oak are members of the birch homologous group based on IgE cross-reactivity to the major allergen Bet v 1. Treatment effects of tree sublingual immunotherapy (SLIT)tablets containing standardized birch pollen extract in participants with birch pollen-induced allergic rhinitis with or without conjunctivitis (AR/C) were evaluated during alder/hazel and oak pollen seasons. METHODS: In a randomized, multinational, double-blind trial (EudraCT-2015-004821-15), 634 participants (12-65 years) with birch pollen-induced AR/C with or without asthma received daily tree SLITtablets (12 SQ-Bet) or placebo before and during tree pollen season (TPS; start of alder/hazel pollen season through birch pollen season). Rescue medication was allowed. The primary endpoint was the total combined score (TCS; sum of rhinoconjunctivitis daily symptom score [DSS] and daily medication score [DMS]) during birch pollen season. TCS, DSS, and DMS during alder/hazel and oak pollen seasons and the continuous TPS (all days during TPS regardless of pollen counts) were analyzed post-hoc. RESULTS: Relative improvements in TCS with tree SLIT-tablets versus placebo were 39.6%, 29.7%, and 36.0% during birch, alder/hazel, and oak pollen seasons, respectively, and 35.0% for continuous TPS (all p≤0.002). Relative improvements in DSS versus placebo were 36.8%, 26.0%, and 31.6% during birch, alder/hazel, and oak pollen seasons, and 31.6% for continuous TPS (all p≤0.003) and in DMS were 49.2%, 43.8%, 45.9%, and 45.3%, respectively (all p≤0.002). CONCLUSIONS: Improvements with tree SLIT-tablets versus placebo during alder/hazel and oak pollen seasons showed internal consistency across seasons and support the clinical relevance of the immunologic crossreactivity between birch pollen homologous allergens.
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