一项为期一年的真实生活非干预性研究，评估SQ HDM舌下含服片（Acarizax）在伴或不伴哮喘的屋尘螨过敏性鼻炎中的安全性、耐受性及治疗效果。
A Real-Life One-Year Non-Interventional Study Assessing Safety, Tolerability, and Treatment Outcome of the SQ HDM SLIT-Tablet (Acarizax) in House Dust Mite Allergic Rhinitis With or Without Asthma.
作者信息
Sidenius Kirsten, Arvidsson Peter, Indbryn Roger, Emanuelsson Cecilia A
机构信息
The Allergy and Lung Clinic, Helsingør, Denmark.
ALK Nordic, Kungsbacka, Sweden.
出版信息
Pulm Ther. 2021 Jun;7(1):221-236. doi: 10.1007/s41030-021-00150-z. Epub 2021 Mar 27.
INTRODUCTION
The aim of this study was to investigate the safety profile, tolerability, and outcome of the SQ house dust mite (HDM) sublingual immunotherapy (SLIT)-tablet after 1 year of treatment in clinical practice among adults with HDM-related allergic rhinitis (AR) ± allergic asthma (AA).
METHODS
In a non-interventional multicenter, observational study, patients were followed at 3 visits for 1 year. Adverse events (AE) were recorded at all visits. Patients graded their allergic symptoms as none, mild, moderate, or severe, and recorded AR and AA medication use. Asthma symptom control was assessed according to the Global Initiative for Asthma (GINA).
RESULTS
One hundred and ninety-eight patients were included; 115 (58%) had AR without asthma and 83 (42%) had both AR and AA. One hundred and sixty-six (84%) patients completed the study. Eighty percent of patients experienced an AE: 151 (75%) AEs were mild, 42 (21%) moderate, and 4 (2%) severe. Three patients (1.5%) reported four events that were considered serious (SAEs). One SAE was considered possibly treatment-related. No anaphylactic reactions occurred. The proportion of patients experiencing allergy symptom reductions by at least one step were 75% (nasal), 62% (eye), 16% (skin), and 13% (other symptoms); 75% of patients with AA experienced a decrease of at least one step in bronchial symptoms. AR medication and inhaled corticosteroids were statistically significant reduced.
CONCLUSION
The SQ HDM SLIT-tablet was safe and well tolerated; the type, frequency, and severity of AEs resembled what RCTs have previously demonstrated. As explorative endpoints, statistically significant reductions in AR and AA symptoms and medication use were seen along with improved asthma control after 1 year of treatment, implying that clinically meaningful changes were seen after 1 year of treatment with the SQ HDM SLIT-tablet.
引言
本研究旨在调查在临床实践中，对于患有与屋尘螨（HDM）相关的变应性鼻炎（AR）±变应性哮喘（AA）的成年人，使用SQ屋尘螨舌下免疫治疗（SLIT）片剂治疗1年后的安全性、耐受性及治疗结果。
方法
在一项非干预性多中心观察性研究中，对患者进行为期1年的3次随访。在所有随访中记录不良事件（AE）。患者将其过敏症状分为无、轻度、中度或重度，并记录AR和AA药物使用情况。根据全球哮喘防治创议（GINA）评估哮喘症状控制情况。
结果
纳入198例患者；115例（58%）患有AR但无哮喘，83例（42%）同时患有AR和AA。166例（84%）患者完成了研究。80%的患者经历了AE：151例（75%）AE为轻度，42例（21%）为中度，4例（2%）为重度。3例患者（1.5%）报告了4起被视为严重不良事件（SAE）的事件。1起SAE被认为可能与治疗有关。未发生过敏反应。经历过敏症状至少减轻一个等级的患者比例分别为：鼻部75%、眼部62%、皮肤16%、其他症状13%；75%的AA患者支气管症状至少减轻一个等级。AR药物和吸入性糖皮质激素的使用在统计学上有显著减少。
结论
SQ HDM SLIT片剂安全且耐受性良好；AE的类型、频率和严重程度与之前随机对照试验（RCT）的结果相似。作为探索性终点，在治疗1年后，AR和AA症状及药物使用在统计学上有显著减少，同时哮喘控制得到改善，这意味着使用SQ HDM SLIT片剂治疗1年后出现了具有临床意义的变化。
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