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- W2171600371 abstract "RationaleThe house dust mite (HDM) SLIT-tablet (ALK, Denmark) has been shown to significantly reduce HDM allergic rhinitis (AR) symptoms in the MERIT trial, which met its primary endpoint (EAACI 2014, Abstr 415,417). To investigate the effect in AR in different subpopulations, we present a subgroup analysis that compares the efficacy of the HDM SLIT-tablet on rhinitis symptoms and medication use in subjects with asthma versus no asthma and mono- versus polysensitised subjects.MethodsMERIT (EudraCT no.2011-002277-38) was a double-blind, placebo-controlled, multi-centre phase III trial including 992 adults with moderate to severe HDM AR despite having received symptomatic treatment. Subjects were randomised 1:1:1 to 1 year of daily treatment with placebo, 6 SQ-HDM or 12 SQ-HDM. The primary endpoint was the total combined rhinitis score (TCRS, sum of rhinitis symptom and medication score) during the last 8 weeks of the treatment. A subgroup analysis was pre-specified in the protocol with respect to differences in average TCRS from placebo depending on asthma status and allergen sensitisation type (not adjusted for multiplicity).ResultsThe analysis showed that differences in average TCRS between active treatment (6 SQ-HDM, 12 SQ-HDM) and placebo were not statistically significant between any of the subgroups (asthma/no-asthma, p=0.81, mono-/polysensitised, p=0.74). Treatment was well-tolerated in all subgroups.ConclusionsThe subgroup analysis showed that there was no statistically significant difference between the effect of the active treatment in reducing HDM AR symptoms in subjects with asthma versus no asthma and mono- versus polysensitised subjects, supporting the use of the HDM SLIT-tablet in these subpopulations. RationaleThe house dust mite (HDM) SLIT-tablet (ALK, Denmark) has been shown to significantly reduce HDM allergic rhinitis (AR) symptoms in the MERIT trial, which met its primary endpoint (EAACI 2014, Abstr 415,417). To investigate the effect in AR in different subpopulations, we present a subgroup analysis that compares the efficacy of the HDM SLIT-tablet on rhinitis symptoms and medication use in subjects with asthma versus no asthma and mono- versus polysensitised subjects. The house dust mite (HDM) SLIT-tablet (ALK, Denmark) has been shown to significantly reduce HDM allergic rhinitis (AR) symptoms in the MERIT trial, which met its primary endpoint (EAACI 2014, Abstr 415,417). To investigate the effect in AR in different subpopulations, we present a subgroup analysis that compares the efficacy of the HDM SLIT-tablet on rhinitis symptoms and medication use in subjects with asthma versus no asthma and mono- versus polysensitised subjects. MethodsMERIT (EudraCT no.2011-002277-38) was a double-blind, placebo-controlled, multi-centre phase III trial including 992 adults with moderate to severe HDM AR despite having received symptomatic treatment. Subjects were randomised 1:1:1 to 1 year of daily treatment with placebo, 6 SQ-HDM or 12 SQ-HDM. The primary endpoint was the total combined rhinitis score (TCRS, sum of rhinitis symptom and medication score) during the last 8 weeks of the treatment. A subgroup analysis was pre-specified in the protocol with respect to differences in average TCRS from placebo depending on asthma status and allergen sensitisation type (not adjusted for multiplicity). MERIT (EudraCT no.2011-002277-38) was a double-blind, placebo-controlled, multi-centre phase III trial including 992 adults with moderate to severe HDM AR despite having received symptomatic treatment. Subjects were randomised 1:1:1 to 1 year of daily treatment with placebo, 6 SQ-HDM or 12 SQ-HDM. The primary endpoint was the total combined rhinitis score (TCRS, sum of rhinitis symptom and medication score) during the last 8 weeks of the treatment. A subgroup analysis was pre-specified in the protocol with respect to differences in average TCRS from placebo depending on asthma status and allergen sensitisation type (not adjusted for multiplicity). ResultsThe analysis showed that differences in average TCRS between active treatment (6 SQ-HDM, 12 SQ-HDM) and placebo were not statistically significant between any of the subgroups (asthma/no-asthma, p=0.81, mono-/polysensitised, p=0.74). Treatment was well-tolerated in all subgroups. The analysis showed that differences in average TCRS between active treatment (6 SQ-HDM, 12 SQ-HDM) and placebo were not statistically significant between any of the subgroups (asthma/no-asthma, p=0.81, mono-/polysensitised, p=0.74). Treatment was well-tolerated in all subgroups. ConclusionsThe subgroup analysis showed that there was no statistically significant difference between the effect of the active treatment in reducing HDM AR symptoms in subjects with asthma versus no asthma and mono- versus polysensitised subjects, supporting the use of the HDM SLIT-tablet in these subpopulations. The subgroup analysis showed that there was no statistically significant difference between the effect of the active treatment in reducing HDM AR symptoms in subjects with asthma versus no asthma and mono- versus polysensitised subjects, supporting the use of the HDM SLIT-tablet in these subpopulations." @default.
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- W2171600371 title "The HDM Slit-Tablet Reduces Symptoms of House Dust Mite Allergic Rhinitis Independently of Asthma Status and Allergen Sensitisation Type; A Subgroup Analysis of Results from a Dbpc Phase III Trial (MERIT)" @default.
- W2171600371 doi "https://doi.org/10.1016/j.jaci.2014.12.1816" @default.
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