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

Pascal Demoly (1, 2, 3) , Jonathan Corren (4) , Peter Creticos (5) , Frédéric de Blay (6) , Philippe Gevaert (7) , Peter Hellings (8) , Krzysztof Kowal (9) , Martine Le Gall (10) , Natalia Nenasheva (11) , Giovanni Passalacqua (12) , Oliver Pfaar (13) , Miguel Tortajada-Girbés (14) , Carmen Vidal (15) , Margitta Worm (16) , Thomas Casale (17)

1 Hôpital Arnaud de Villeneuve [CHRU Montpellier]
2 EPAR - Epidemiology of Allergic and Respiratory Diseases Department [iPlesp]
3 IDESP - Institut Desbrest de santé publique
4 UCLA - University of California [Los Angeles]
5 Johns Hopkins University School of Medicine [Baltimore]
6 CHU Strasbourg - Centre Hospitalier Universitaire [Strasbourg]
7 UGENT - Universiteit Gent = Ghent University
8 University Hospitals Leuven [Leuven]
9 MUB - Medical University of Białystok
10 Stallergenes
11 MHRF - Ministry of Health of the Russian Federation
12 UniGe - Università degli studi di Genova = University of Genoa
13 Philipps Universität Marburg = Philipps University of Marburg
14 UV - Universitat de València
15 USC - Universidade de Santiago de Compostela [Spain]
16 Charité - UniversitätsMedizin = Charité - University Hospital [Berlin]
17 USF - University of South Florida [Tampa]

Background: Allergic rhinitis 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: We sought 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 allergic rhinitis. 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 end point was the average total combined score during 4 weeks at the end of the treatment period. Results: A total of 1607 participants were randomized, and 1476 (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 average total combined score in the 300 IR group (3.62) was significantly lower (P < .0001) than in the placebo group (4.35), with a relative least squares mean difference of −16.9% (95% CI, −24.0% to −9.2%). All prespecified secondary end points 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 allergic rhinitis.

Mots clés: allergen immunotherapy; allergic rhinitis; allergy; house dust mite; sublingual immunotherapy; tablet; total combined score; symptom score; medication score; quality of life

Domaines: Allergologie; Immunothérapie

Pascal Demoly, Jonathan Corren, Peter Creticos, Frédéric de Blay, Philippe Gevaert, et al.. 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. Journal of Allergy and Clinical Immunology, 2021, 147 (3), pp.1020 - 1030.e10. ⟨10.1016/j.jaci.2020.07.036⟩. ⟨hal-03613293⟩