Abstract | 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:
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Authors | Pascal Demoly, Jonathan Corren, Peter Creticos, Frédéric De Blay, Philippe Gevaert, Peter Hellings, Krzysztof Kowal, Martine Le Gall, Natalia Nenasheva, Giovanni Passalacqua, Oliver Pfaar, Miguel Tortajada-Girbés, Carmen Vidal, Margitta Worm, Thomas B Casale |
Journal | The Journal of allergy and clinical immunology
(J Allergy Clin Immunol)
Vol. 147
Issue 3
Pg. 1020-1030.e10
(03 2021)
ISSN: 1097-6825 [Electronic] United States |
PMID | 32890575
(Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2020. Published by Elsevier Inc. |
Chemical References |
- Antigens, Dermatophagoides
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Topics |
- Adolescent
- Adult
- Animals
- Antigens, Dermatophagoides
(immunology)
- Double-Blind Method
- Drug-Related Side Effects and Adverse Reactions
- Female
- Humans
- International Cooperation
- Male
- Placebo Effect
- Pyroglyphidae
- Quality of Life
- Rhinitis, Allergic
(immunology, therapy)
- Severity of Illness Index
- Sublingual Immunotherapy
(methods)
- Young Adult
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