屋尘螨舌下免疫治疗片剂在变应性鼻结膜炎青少年中的安全性：全球临床试验结果。
House dust mite sublingual immunotherapy tablet safety in adolescents with allergic rhinoconjunctivitis: Worldwide clinical trial results.
机构信息
HNO Praxis Am Neckar, Heidelberg, Germany.
Bernstein Clinical Research Center and Division of Immunology, Allergy and Rheumatology, University of Cincinnati College of Medicine, Cincinnati, Ohio.
出版信息
Ann Allergy Asthma Immunol. 2023 Jun;130(6):797-804.e2. doi: 10.1016/j.anai.2023.03.006. Epub 2023 Mar 15.
BACKGROUND
The house dust mite (HDM) sublingual immunotherapy (SLIT)-tablet is a treatment option for allergic rhinitis with/without conjunctivitis (AR/C) approved in adults worldwide and in adolescents in some countries.
OBJECTIVE
To supplement existing adolescent HDM SLIT-tablet safety data by conducting the MT-18 trial in adolescents.
METHODS
MT-18 (EudraCT:2020-000446-34) was a phase 3, open-label, single-arm, 28-day safety trial of daily HDM SLIT-tablet (12 SQ-HDM dose) in European adolescents (12-17 years) with HDM AR/C, with or without asthma. The primary end point was at least 1 treatment-emergent adverse event (TEAE). MT-18 results were compared with 12 SQ-HDM adolescent subpopulation data from previously described 1-year phase 3 trials conducted in North America (P001; clinicaltrials.gov:NCT01700192) or Japan (TO-203-3-2; JapicCTI:121848).
RESULTS
No treatment-related anaphylaxis, epinephrine administrations, severe local swellings, severe mouth or throat edema, or eosinophilic esophagitis occurred in the trials. For MT-18 (N = 253), P001 (N adolescents = 189), and TO-203-3-2 (N adolescents = 206), the percentage of adolescents treated with 12 SQ-HDM reporting any TEAE was 88%, 95%, and 93%, respectively, and the percentage reporting any treatment-related AE (TRAE) was 86%, 93%, and 66%, respectively. The most common TRAEs were local application site reactions. Most TRAEs were mild in intensity and were typically experienced the first 1 to 2 days of treatment. There were no asthma-related TEAEs with the HDM SLIT-tablet. The safety profile appears similar between adolescents with or without asthma at baseline.
CONCLUSION
The HDM SLIT-tablet was well tolerated in European, North American, and Japanese adolescents with HDM AR/C, indicating safety of the HDM SLIT-tablet is insensitive to age or geographic region.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: (P001: NCT01700192); EudraCT: (MT-18; 2020-000446-34); JapicCTI: (TO-203-3-2; 121848).
背景
屋尘螨舌下免疫疗法（SLIT）片剂是一种治疗变应性鼻炎伴/不伴结膜炎（AR/C）的选择，已在全球范围内获得批准用于成人，在一些国家也批准用于青少年。
目的
通过在青少年中进行 MT-18 试验，补充现有的青少年屋尘螨 SLIT 片剂安全性数据。
方法
MT-18（EudraCT：2020-000446-34）是一项 3 期、开放性、单臂、28 天的每日屋尘螨 SLIT 片剂（12 SQ-HDM 剂量）安全性试验，纳入了欧洲青少年（12-17 岁）的屋尘螨 AR/C，包括有或无哮喘。主要终点是至少 1 例治疗后出现的不良事件（TEAE）。MT-18 的结果与之前在北美（P001；clinicaltrials.gov：NCT01700192）或日本（TO-203-3-2；JapicCTI：121848）进行的为期 1 年的 3 期试验中 12 SQ-HDM 青少年亚组数据进行了比较。
结果
试验中未发生与治疗相关的过敏反应、肾上腺素给药、严重局部肿胀、严重口咽水肿或嗜酸性食管炎。对于 MT-18（N=253）、P001（N 名青少年=189）和 TO-203-3-2（N 名青少年=206），接受 12 SQ-HDM 治疗的青少年报告任何 TEAE 的比例分别为 88%、95%和 93%，报告任何治疗相关不良事件（TRAE）的比例分别为 86%、93%和 66%。最常见的 TRAE 是局部应用部位反应。大多数 TRAE 为轻度，通常在治疗的第 1 至 2 天发生。屋尘螨 SLIT 片剂与哮喘无关的 TEAEs。屋尘螨 SLIT 片剂在基线时有或无哮喘的青少年中均具有良好的耐受性，表明其安全性不受年龄或地理位置的影响。
结论
屋尘螨 SLIT 片剂在欧洲、北美和日本的屋尘螨 AR/C 青少年中耐受良好，表明屋尘螨 SLIT 片剂的安全性对年龄或地理区域不敏感。
试验注册
ClinicalTrials.gov 标识符：（P001：NCT01700192）；EudraCT：（MT-18；2020-000446-34）；JapicCTI：（TO-203-3-2；121848）。
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