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.

ABSTRACT

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.