Onset of Action of Sublingual Tablets of House Dust Mite Allergen Extracts in Adults
Authors: Pascal M. Demoly, Karl-Christian Bergmann, Michel Melac, Hélène Nguyen, Marine Frereux, Robert K. Zeldin
Journal: Journal of Allergy and Clinical Immunology (2013)

RationaleThe efficacy and safety of house dust mite (HDM) sublingual immunotherapy tablets have been demonstrated. Here, we determined the time to onset of the treatment effect.MethodsIn a double-blind study, adults with HDM-induced allergic rhinitis were randomized to receive a daily dose of either 500IR or 300IR of sublingual tablets of HDM (Dermatophagoides pteronyssinus and D. farinae) allergen extracts or placebo for one year, and were followed-up during the subsequent treatment-free year. Patients scored their rhinitis symptoms and use of symptomatic medications. The primary efficacy variable was the average adjusted symptom score (AASS), which adjusts symptom scores for rescue medication use. To determine the onset of action, the AASS was calculated over 2 weeks every 2 months during the treatment period, and analyzed by repeated measures ANCOVA mixed model.ResultsA total of 509 patients were randomized: 500IR (n=169), 300IR (n=170) or placebo (n=170). The difference versus placebo in the least-square means AASS was statistically significant starting from month 4 of the treatment period, for both the 500IR and 300IR groups (p < 0.05). This represented an improvement relative to placebo for the 500IR group of 18% (−0.80) at month 4 and of 19% (−0.77) at month 12, and for the 300IR group of 22% (−0.99) at month 4 and of 17% (−0.67) at month 12.ConclusionsEfficacy of 500IR and 300IR sublingual tablets of HDM allergen extracts was demonstrated beginning four months after treatment initiation. RationaleThe efficacy and safety of house dust mite (HDM) sublingual immunotherapy tablets have been demonstrated. Here, we determined the time to onset of the treatment effect. The efficacy and safety of house dust mite (HDM) sublingual immunotherapy tablets have been demonstrated. Here, we determined the time to onset of the treatment effect. MethodsIn a double-blind study, adults with HDM-induced allergic rhinitis were randomized to receive a daily dose of either 500IR or 300IR of sublingual tablets of HDM (Dermatophagoides pteronyssinus and D. farinae) allergen extracts or placebo for one year, and were followed-up during the subsequent treatment-free year. Patients scored their rhinitis symptoms and use of symptomatic medications. The primary efficacy variable was the average adjusted symptom score (AASS), which adjusts symptom scores for rescue medication use. To determine the onset of action, the AASS was calculated over 2 weeks every 2 months during the treatment period, and analyzed by repeated measures ANCOVA mixed model. In a double-blind study, adults with HDM-induced allergic rhinitis were randomized to receive a daily dose of either 500IR or 300IR of sublingual tablets of HDM (Dermatophagoides pteronyssinus and D. farinae) allergen extracts or placebo for one year, and were followed-up during the subsequent treatment-free year. Patients scored their rhinitis symptoms and use of symptomatic medications. The primary efficacy variable was the average adjusted symptom score (AASS), which adjusts symptom scores for rescue medication use. To determine the onset of action, the AASS was calculated over 2 weeks every 2 months during the treatment period, and analyzed by repeated measures ANCOVA mixed model. ResultsA total of 509 patients were randomized: 500IR (n=169), 300IR (n=170) or placebo (n=170). The difference versus placebo in the least-square means AASS was statistically significant starting from month 4 of the treatment period, for both the 500IR and 300IR groups (p < 0.05). This represented an improvement relative to placebo for the 500IR group of 18% (−0.80) at month 4 and of 19% (−0.77) at month 12, and for the 300IR group of 22% (−0.99) at month 4 and of 17% (−0.67) at month 12. A total of 509 patients were randomized: 500IR (n=169), 300IR (n=170) or placebo (n=170). The difference versus placebo in the least-square means AASS was statistically significant starting from month 4 of the treatment period, for both the 500IR and 300IR groups (p < 0.05). This represented an improvement relative to placebo for the 500IR group of 18% (−0.80) at month 4 and of 19% (−0.77) at month 12, and for the 300IR group of 22% (−0.99) at month 4 and of 17% (−0.67) at month 12. ConclusionsEfficacy of 500IR and 300IR sublingual tablets of HDM allergen extracts was demonstrated beginning four months after treatment initiation. Efficacy of 500IR and 300IR sublingual tablets of HDM allergen extracts was demonstrated beginning four months after treatment initiation.