TY - JOUR
T1 - A 300 IR sublingual tablet is an effective, safe treatment for house dust mite–induced allergic rhinitis
T2 - An international, double-blind, placebo-controlled, randomized phase III clinical trial
AU - Demoly, Pascal
AU - Corren, Jonathan
AU - Creticos, Peter
AU - De Blay, Frédéric
AU - Gevaert, Philippe
AU - Hellings, Peter
AU - Kowal, Krzysztof
AU - Le Gall, Martine
AU - Nenasheva, Natalia
AU - Passalacqua, Giovanni
AU - Pfaar, Oliver
AU - Tortajada-Girbés, Miguel
AU - Vidal, Carmen
AU - Worm, Margitta
AU - Casale, Thomas B.
N1 - Funding Information:
The study was sponsored and funded by Stallergenes Greer (Antony, France).
Funding Information:
Disclosure of potential conflict of interest: P. Demoly has received consulting fees, honoraria for lectures, and/or research funding from ALK, ASIT Biotech, AstraZeneca, Bausch & Lomb, Chiesi, IQVIA, Ménarini, Mylan, Novartis, Sanofi, Stallergenes Greer, and ThermoFisher Scientific. J. Corren has received consulting fees, honoraria for lectures, and/or research funding from AstraZeneca, Genentech, Novartis, Regeneron Pharmaceuticals, Inc, Sanofi, and Stallergenes Greer. P. Creticos has received consulting fees, honoraria for lectures, and/or research funding from Stallergenes Greer, Allergy Therapeutics, ALK, and ASIT, and royalties from UpToDate. F. De Blay has received consulting fees, honoraria for lectures, and/or research funding from ALK, AstraZeneca, GlaxoSmithKline (GSK), Novartis, Teva, Sanofi, and Stallergenes Greer. P. Gevaert has received consulting fees, honoraria for lectures, and/or research funding from Stallergenes Greer, 3NT, Ablynx, ALK, Argenx, Bekaert Textiles, Genentech, Hall Allergy, Medtronic, Novartis, Regeneron, Roche, Sanofi-Genzyme, Teva, and Thermo Fisher. P. Hellings has received consulting fees, honoraria for lectures, and/or research funding from Mylan, Sanofi, Allergopharma, and Stallergenes Greer. K. Kowal has received consulting fees, honoraria for lectures, and/or research funding from ALK-Abello, AstraZeneca, Berlin Chemie, Chiesi, Hal Allergy, Meda Pharma, Merk Allergopharma, and Orion Pharma. M. Le Gall is an employee of Stallergenes Greer. N. Nenasheva has received consulting fees, honoraria for lectures, and/or research funding from AstraZeneca, Chiesi, MSD, Novartis, Sanofi, and Stallergenes Greer. G. Passalacqua has received consulting fees, honoraria for lectures, and/or research funding from Stallergenes, Lofarma, ALK-Abellò, and Allergofarma. O. Pfaar reports grants and personal fees from Stallergenes Greer, during the conduct of the study; grants and personal fees from ALK-Abelló, Allergopharma, Stallergenes Greer, HAL Allergy Holding B.V./HAL Allergie GmbH, Bencard Allergie GmbH/Allergy Therapeutics, Lofarma, ASIT Biotech Tools S.A., Laboratorios LETI/LETI Pharma, and Anergis S.A.; grants from Biomay, Circassia, and GSK; and personal fees from Meda Pharma/MYLAN, Mobile Chamber Experts (a GA2LEN Partner), Indoor Biotechnologies, Astellas Pharma Global, EUFOREA, Roxall, Novartis, Sanofi Aventis, Med Update Europe GmbH, and streamedup! GmbH, outside the submitted work. M. Tortajada-Girbés has received consulting fees, honoraria for lectures, and/or research funding from Stallergenes Greer, Novartis, GSK, Sanofi-Genzyme, and Allergopharma. C. Vidal has received consulting fees, honoraria for lectures, and/or research funding from ALK, Stallergenes Greer, Allergy Therapeutics, Chiesi, GSK, and AstraZeneca. M. Worm has received consulting fees, honoraria for lectures, and/or research funding from ALK-Abelló Arzneimittel GmbH, Meda Pharma GmbH & Co. KG, Allergopharma GmbH & Co. KG, Bencard Allergie GmbH, Sanofi-Aventis Deutschland GmbH, Regeneron Pharmaceuticals, Inc, and Stallergenes Greer. T. B. Casale has received consulting fees, honoraria for lectures, and/or research funding from Stallergenes.
Publisher Copyright:
© 2020
PY - 2021/3
Y1 - 2021/3
N2 - 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.
AB - 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.
KW - Allergen immunotherapy
KW - allergic rhinitis
KW - allergy
KW - house-dust mite
KW - medication score
KW - sublingual immunotherapy
KW - symptom score
KW - tablet
KW - total combined score
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U2 - 10.1016/j.jaci.2020.07.036
DO - 10.1016/j.jaci.2020.07.036
M3 - Article
C2 - 32890575
AN - SCOPUS:85092516186
VL - 147
SP - 1020-1030.e10
JO - Journal of Allergy and Clinical Immunology
JF - Journal of Allergy and Clinical Immunology
SN - 0091-6749
IS - 3
ER -