背景:SQHouseDustMite(HDM)舌下免疫疗法(SLIT)-片剂(Acarizax)是欧洲监管机构授权的唯一一种过敏原免疫疗法,用于治疗HDM诱导的过敏性哮喘(AA),但不能很好地控制吸入糖皮质激素并与轻度至重度HDM过敏性鼻炎(AR)相关。这项研究的目的是增加SQHDMSLIT-片剂在AR患者中的安全性的证据。单独或与AA,在现实生活条件下。
方法:这是法语的“现实生活”,多中心,非比较性,纵向,前瞻性研究。它包括开始使用SQHDMSLIT片剂治疗持续性中度至重度HDMAR或AA的患者,这些患者不能通过吸入皮质类固醇很好地控制并与轻度至重度HDMAR相关。在第一次摄入和整个研究中收集不良事件(AE)。根据治疗开始前的哮喘控制,使用Logistic回归比较安全性。
结果:在2018年5月9日至2019年5月29日之间,在185个地点招募了1526名患者,并将1483名患者纳入了安全人群(SAF)。其中,33.6%有疑似AA临床表现。18.2%的患者未控制哮喘,部分控制27.9%,控制良好53.8%。总的来说,31.9%的SAF患者经历至少一次AE。在单独的AR患者中,AE患者的百分比为29.9%,在AA患者中为35.9%(p=0.0193)。根据纳入时的哮喘控制,AE或SAE的发生率没有显着差异(报告的SAE中有2.2%为未控制的哮喘患者,部分控制1.4%,控制良好1.1%)。
结论:总体结果表明,SQHDMSLIT-Tablet的安全性与以前的研究报告一致,不管哮喘控制。
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.