Efficacy and safety of a @entity3584 -modified house dust mite extract in XXXX .

@entity1 @entity13923 @entity7370 @entity2023 @entity7130 @entity3584 @entity2490 @entity1191 @entity6711
BACKGROUND: Modification of allergens by @entity3584 in extracts used for immunotherapy reduces the risk for side effects, but therapeutic efficacy of such extracts requires further evaluation. The aim of this study was to evaluate the efficacy and safety of immunotherapy with PURETHAL Mites (PM), a single-strength @entity3584 -modified @entity13923 -adsorbed extract of @entity6711 ( @entity6711 ). METHODS: In a multicenter, randomized, placebo-controlled double-blind setting, @entity6711 -allergic subjects (n = 140) were treated with modified allergen extract or placebo over a 1-year period. The primary outcome parameter was a combined symptom and medication score (clinical index score [CIS]). Secondary efficacy parameters were the result of a titrated conjunctival provocation test (CPT), @entity2490 / @entity7370 quality of life (RQL) score, and serum concentrations of IgE and IgG against specific @entity6711 allergens and a documentation of adverse events (AE). RESULTS: We evaluated 140 @entity1 (66 treatment and 74 placebo) for clinical efficacy. The allergoid treatment for 1 year resulted in significantly greater CIS improvement and higher RQL scores. The response threshold in the titrated @entity1191 (p = 0.009) and the serum concentrations of IgG4 (p < 0.001) against @entity7130 allergens after treatment were also significantly different between groups. In total, 88 @entity1 (46 PM/42 placebo) out of a safety population of 145 reported 278 (158 PM/120 placebo) AE. Except for local reactions, no specific AE appeared to be associated with PURETHAL Mites (HAL-Allergy, Leiden, The Netherlands). CONCLUSION: The findings of this study indicate that allergen injection therapy with modified @entity6711 extract is superior to placebo in @entity2023 therapy. The treatment was well tolerated and no serious drug-related AE were observed.
