A 300°IR sublingual tablet is an effective, safe treatment for house-dust-mite-induced allergic rhinitis: an international, double-blind, placebo-controlled, randomized Phase III clinical trial.

A 300°IR sublingual tablet is an effective, safe treatment for house-dust-mite-induced allergic rhinitis: an international, double-blind, placebo-controlled, randomized Phase III clinical trial.:

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A 300°IR sublingual tablet is an effective, safe treatment for house-dust-mite-induced allergic rhinitis: an international, double-blind, placebo-controlled, randomized Phase III clinical trial.

J Allergy Clin Immunol. 2020 Sep 02;:

Authors: Demoly P, Corren J, Creticos P, De Blay F, Gevaert P, Hellings P, Kowal K, Le Gall M, Nenasheva N, Passalacqua G, Pfaar O, Tortajada-Girbés M, Vidal C, Worm M, Casale TB

Abstract

BACKGROUND: Allergic rhinitis (AR) induced by house dust mites (HDMs) is a highly prevalent but often underdiagnosed and undertreated/untreated chronic disease. It often has a negative impact on sleep, work, leisure activities, and health-related quality of life. Allergen immunotherapy is a proven, safe treatment for respiratory allergies.

OBJECTIVE: To assess the efficacy and safety of a 300 index of reactivity (IR) sublingual tablet formulation of Dermatophagoides pteronyssinus:Dermatophagoides farinae 1:1 extract in adolescents (aged ≥12) and adults with moderate-to-severe HDM-induced AR.

METHODS: In a Phase III, international, double-blind, placebo-controlled, randomized clinical trial, participants received approximately 12 months of treatment with placebo or the 300°IR tablet. The primary endpoint was the average total combined score (aTCS) during 4 weeks at the end of the treatment period.

RESULTS: 1,607 participants were randomized, and 1,476 (including 555 (37.6%) with concomitant mild controlled asthma at inclusion) comprised the full analysis set. Over the primary evaluation period, the least squares mean aTCS in the 300°IR group (3.62) was significantly lower (p<0.0001) than in the placebo group (4.35), with a relative least squares mean difference of -16.9% [95% confidence interval: -24.0%; -9.2%]. All pre-specified secondary endpoints were consistently improved in the 300°IR group, relative to placebo. The 300°IR tablet was generally well tolerated. Treatment-related adverse events (mainly mild or moderate local reactions) were reported for 51.0% of the patients in the 300°IR group and 14.9% in the placebo group.

CONCLUSIONS: The 300°IR sublingual HDM tablet is an effective, safe treatment for HDM-induced AR. (NCT02443805, EudraCT 2014-004223-46) CLINICAL IMPLICATIONS: A 300 index of reactivity sublingual tablet formulation of Dermatophagoides pteronyssinus:Dermatophagoides farinae extract is a safe, effective treatment for moderate-to-severe house-dust-mite-induced allergic rhinitis.



PMID: 32890575 [PubMed - as supplied by publisher]