3110 Effective Treatment of House Dust Mite (HDM) Allergic Rhinitis with the SQ HDM Slit-Tablet; Results from a Dbpc Phase III Trial

Friday, 16 October 2015
Hall D1 Foyer (Floor 3) (Coex Convention Center)

Pascal Demoly, MD, PhD , Allergy Division, Pulmonology Department, University Hospital of Montpellier and Sorbonne UniversitÚs, UPMC Paris 06, Montpellier, France

Elke Decot, MD , Private Practice, Dreieich, Germany

Verners Lozovskis, MD , Private Practice, Riga, Latvia

Dorte Rehm, PhD , ALK a/S, Horsholm, Denmark

J÷rg Kleine-Tebbe, MD , Allergy & Asthma Center Westend, Berlin, Germany

Effective Treatment of House Dust Mite (HDM) Allergic Rhinitis with the SQ HDM SLIT-Tablet; Results from a DBPC Phase III Trial

Demoly P1., Decot E2., Lozovskis V3., Rehm D4., and Kleine-Tebbe J5.

1DÚpartement de Pneumologie et Addictologie, University Hospital of Montpellier, 34295 Montpellier cedex 05, France

2Private practice, 63303 Dreieich, Germany

3Private practice, LV-1003 Riga, Latvia

4ALK A/S, 2970, Horsholm, Denmark,

5 Allergy & Asthma Center Westend, Outpatient Clinic & Research Center, Berlin, D-14050, Germany

Background: The SQ HDM SLIT-tablet (ALK, Denmark) is currently being developed for treatment of HDM respiratory allergic disease in Europe, North America and Asia (Japan). Here we present the primary efficacy results from a European trial that was initiated to investigate the efficacy and safety of the SQ HDM SLIT-tablet in HDM allergic rhinitis (AR).

Method: The trial (EudraCT no. 2011-002277-38) was a double-blind, placebo-controlled phase III trial conducted in 12 European countries and including 992 adult subjects 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, i.e. sum of rhinitis symptom and medication score) during the efficacy evaluation period (~last 8 weeks of the treatment period). Key secondary endpoints were rhinitis symptoms, symptomatic medication use, quality of life, and the combined rhinoconjunctivitis score.

Results: The trial met its primary objective. The primary analysis (full analysis set with multiple imputation of missing data) demonstrated absolute reductions of the TCRS of 1.07 and 1.09 compared to placebo for 6 SQ-HDM and 12 SQ-HDM, respectively (p=0.004). For the full analysis set with observed data these numbers were 1.18 and 1.22, respectively (p<0.01 for both doses). A statistically significant treatment effect was evident from 14 weeks of treatment and onwards. All key secondary endpoints were met for 12 SQ-HDM with statistically significant reductions of rhinitis symptoms, symptomatic medication use, improved quality of life, and a reduced combined rhinoconjunctivitis score in the efficacy evaluation period compared to placebo.

Conclusion: The trial confirmed the efficacy of both 6 SQ-HDM and 12 SQ-HDM in adult subjects with HDM AR. Fast onset of action was observed with a treatment effect already present from 14 weeks of treatment and onwards.