BACKGROUND: @entity78 -adsorbed allergen extracts are used for subcutaneous immunotherapy to avoid the use of @entity5715 adjuvants. OBJECTIVES: A double-blind, placebo-controlled study was performed in order to confirm the safety and assess the efficacy of a standardized five-grass-pollen extract adsorbed onto @entity78 for specific immunotherapy (IT). METHODS: Twenty-nine @entity1 with seasonal @entity7370 were randomized to receive either the active preparation (16 @entity1 ) or placebo (13 @entity1 ), in a 1-year study. During the increasing dose phase, an extract ranging from 0.1 IR per ml to 50 IR per ml was administered at a rate of one subcutaneous injection per week until a maintenance dose was reached. The @entity1 were assessed by symptom diary and rescue medications during seasonal exposure and specific nasal and skin reactivity before and after IT. Immunological parameters (specific IgE and IgG4 antibodies) were assessed before, during and after IT. RESULTS: The overall symptoms score (mean AUC) was not significantly different between the IT group and the placebo group during grass-pollen exposure (49.6 vs. 56, respectively). The total medication score (mean AUC) was significantly lower in the IT group than in the placebo group (11 vs. 41, P < 0.01, Mann-Whitney U-test). The cumulative symptom/medication score was significantly lower in the IT group than in the placebo group (64.5 vs. 102.3, P < 0.05, U-test). A significant increase in nasal reactivity threshold was observed after IT in the IT group (21. 4 IR/mL before IT vs. 63.4 IR/mL after IT, P < 0.01, Wilcoxon), whereas no significant changes were observed in the placebo group (31.0 IR/mL before IT vs. 37.7 IR/mL after IT). IT induced a significant reduction in grass pollen cutaneous reactivity in the actively treated group (P < 0.001). A significant increase in serum-specific IgG4 antibody response was observed in the IT group (3.1% before IT vs. 10.1% after IT, P < 0.001). Nine @entity1 in the IT group developed moderate immediate systemic reactions vs. two @entity1 in the placebo group. CONCLUSION: Specific immunotherapy with @entity78 -adsorbed standardized grass pollen extract was safe and effective for the treatment of @entity1 with @entity56 .

Immunotherapy with a @entity78 -adsorbed five-grass-pollen extract in seasonal XXXX : a double-blind, placebo-controlled study.

@entity1 :: ('9606', 'Species') :: ['patients'] @entity7370 :: ('OMIM:613207', 'Disease') :: ['rhinoconjunctivitis'] @entity78 :: ('MESH:C020243', 'Chemical') :: ['calcium phosphate', 'Calcium phosphate'] @entity56 :: ('MESH:D004342', 'Disease') :: ['seasonal allergic rhinoconjunctivitis'] @entity5715 :: ('CHEBI:28984', 'Chemical') :: ['aluminium']
@entity7370 :: (OMIM:613207,Disease) :: ['rhinoconjunctivitis']
