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The SQ HDM SLIT‐Tablet is safe and well tolerated in patients with House Dust Mite allergic rhinitis with or without asthma: A “real‐life” French study

BACKGROUND: The SQ House Dust Mite (HDM) SubLingual ImmunoTherapy (SLIT)‐Tablet (Acarizax) is the only allergen immunotherapy authorized by European regulatory authorities to treat HDM‐induced allergic asthma (AA) that is not well‐controlled by inhaled corticosteroids and associated with mild‐to‐sev...

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Autores principales: Demoly, Pascal, Leroyer, Christophe, Serrano, Elie, Le Maux, Annelore, Magnier, Gabrielle, Chartier, Antoine
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8967264/
https://www.ncbi.nlm.nih.gov/pubmed/35344293
http://dx.doi.org/10.1002/clt2.12129
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author Demoly, Pascal
Leroyer, Christophe
Serrano, Elie
Le Maux, Annelore
Magnier, Gabrielle
Chartier, Antoine
author_facet Demoly, Pascal
Leroyer, Christophe
Serrano, Elie
Le Maux, Annelore
Magnier, Gabrielle
Chartier, Antoine
author_sort Demoly, Pascal
collection PubMed
description BACKGROUND: The SQ House Dust Mite (HDM) SubLingual ImmunoTherapy (SLIT)‐Tablet (Acarizax) is the only allergen immunotherapy authorized by European regulatory authorities to treat HDM‐induced allergic asthma (AA) that is not well‐controlled by inhaled corticosteroids and associated with mild‐to‐severe HDM allergic rhinitis (AR). The aim of this study was to add evidence on the safety of the SQ HDM SLIT‐Tablet in patients with AR, alone or with AA, under real‐life conditions. METHODS: This was a French “real‐life”, multicenter, non‐comparative, longitudinal, prospective study. It included patients initiating the SQ HDM SLIT‐Tablet for either persistent moderate‐to‐severe HDM AR or AA not well‐controlled by inhaled corticosteroids and associated with mild‐to‐severe HDM AR. Adverse Events (AEs) were collected at the first intake and throughout the study. Logistic regression was used to compare safety according to asthma control before treatment initiation. RESULTS: Between May 09, 2018 and May 29, 2019, 1526 patients were enrolled at 185 sites and 1483 were included in the safety population (SAF). Of them, 33.6% had suspected clinical manifestations of AA. Asthma was uncontrolled for 18.2% of the patients, partially controlled for 27.9% and well‐controlled for 53.8%. Overall, 31.9% of the SAF patients experienced at least one AE. The percentage of patients with AEs was 29.9% among patients with AR alone and 35.9% among those with AA (p = 0.0193). No significant difference was observed in the rate of AE or SAE depending on asthma control at inclusion (2.2% of SAEs reported for patients with uncontrolled asthma, 1.4% for partly controlled and 1.1% for well‐controlled). CONCLUSIONS: The overall results indicate a good SQ HDM SLIT‐Tablet safety profile consistent with that reported in previous studies, regardless of asthma control.
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spelling pubmed-89672642022-04-05 The SQ HDM SLIT‐Tablet is safe and well tolerated in patients with House Dust Mite allergic rhinitis with or without asthma: A “real‐life” French study Demoly, Pascal Leroyer, Christophe Serrano, Elie Le Maux, Annelore Magnier, Gabrielle Chartier, Antoine Clin Transl Allergy Original Article BACKGROUND: The SQ House Dust Mite (HDM) SubLingual ImmunoTherapy (SLIT)‐Tablet (Acarizax) is the only allergen immunotherapy authorized by European regulatory authorities to treat HDM‐induced allergic asthma (AA) that is not well‐controlled by inhaled corticosteroids and associated with mild‐to‐severe HDM allergic rhinitis (AR). The aim of this study was to add evidence on the safety of the SQ HDM SLIT‐Tablet in patients with AR, alone or with AA, under real‐life conditions. METHODS: This was a French “real‐life”, multicenter, non‐comparative, longitudinal, prospective study. It included patients initiating the SQ HDM SLIT‐Tablet for either persistent moderate‐to‐severe HDM AR or AA not well‐controlled by inhaled corticosteroids and associated with mild‐to‐severe HDM AR. Adverse Events (AEs) were collected at the first intake and throughout the study. Logistic regression was used to compare safety according to asthma control before treatment initiation. RESULTS: Between May 09, 2018 and May 29, 2019, 1526 patients were enrolled at 185 sites and 1483 were included in the safety population (SAF). Of them, 33.6% had suspected clinical manifestations of AA. Asthma was uncontrolled for 18.2% of the patients, partially controlled for 27.9% and well‐controlled for 53.8%. Overall, 31.9% of the SAF patients experienced at least one AE. The percentage of patients with AEs was 29.9% among patients with AR alone and 35.9% among those with AA (p = 0.0193). No significant difference was observed in the rate of AE or SAE depending on asthma control at inclusion (2.2% of SAEs reported for patients with uncontrolled asthma, 1.4% for partly controlled and 1.1% for well‐controlled). CONCLUSIONS: The overall results indicate a good SQ HDM SLIT‐Tablet safety profile consistent with that reported in previous studies, regardless of asthma control. John Wiley and Sons Inc. 2022-03-23 /pmc/articles/PMC8967264/ /pubmed/35344293 http://dx.doi.org/10.1002/clt2.12129 Text en © 2022 The Authors. Clinical and Translational Allergy published by John Wiley and Sons Ltd on behalf of European Academy of Allergy and Clinical Immunology. https://creativecommons.org/licenses/by/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
spellingShingle Original Article
Demoly, Pascal
Leroyer, Christophe
Serrano, Elie
Le Maux, Annelore
Magnier, Gabrielle
Chartier, Antoine
The SQ HDM SLIT‐Tablet is safe and well tolerated in patients with House Dust Mite allergic rhinitis with or without asthma: A “real‐life” French study
title The SQ HDM SLIT‐Tablet is safe and well tolerated in patients with House Dust Mite allergic rhinitis with or without asthma: A “real‐life” French study
title_full The SQ HDM SLIT‐Tablet is safe and well tolerated in patients with House Dust Mite allergic rhinitis with or without asthma: A “real‐life” French study
title_fullStr The SQ HDM SLIT‐Tablet is safe and well tolerated in patients with House Dust Mite allergic rhinitis with or without asthma: A “real‐life” French study
title_full_unstemmed The SQ HDM SLIT‐Tablet is safe and well tolerated in patients with House Dust Mite allergic rhinitis with or without asthma: A “real‐life” French study
title_short The SQ HDM SLIT‐Tablet is safe and well tolerated in patients with House Dust Mite allergic rhinitis with or without asthma: A “real‐life” French study
title_sort sq hdm slit‐tablet is safe and well tolerated in patients with house dust mite allergic rhinitis with or without asthma: a “real‐life” french study
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8967264/
https://www.ncbi.nlm.nih.gov/pubmed/35344293
http://dx.doi.org/10.1002/clt2.12129
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