用于重度未控制哮喘患者在家中自行注射tezepelumab的预充式注射器及自动注射器的功能与性能
Functionality and Performance of an Accessorized Pre-Filled Syringe and an Autoinjector for At-Home Administration of Tezepelumab in Patients with Severe, Uncontrolled Asthma.
作者信息
Alpizar Sady, Megally Ayman, Chen Claudia, Raj Abhi, Downie John, Colice Gene
机构信息
Clinical Research Trials of Florida, Inc., Tampa, FL, USA.
Late-Stage Development, Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.
出版信息
J Asthma Allergy. 2021 Apr 19;14:381-392. doi: 10.2147/JAA.S305114. eCollection 2021.
BACKGROUND
Tezepelumab is an anti-thymic stromal lymphopoietin monoclonal antibody in development for the treatment of severe asthma. This study assessed the functionality and performance of an accessorized pre-filled syringe (APFS) and an autoinjector (AI) for administration of tezepelumab in the clinic and at home.
METHODS
This phase 3, multicenter, randomized, open-label, parallel-group study (PATH-HOME, ClinicalTrials.gov identifier: NCT03968978) was conducted in patients aged 12-80 years with asthma that was uncontrolled despite treatment with medium- to high-dose inhaled corticosteroids plus at least one additional controller medication. Patients received six subcutaneous doses of tezepelumab 210 mg via APFS or AI. The first dose was administered by a healthcare professional, and patients or caregivers administered subsequent doses. First, second, third and final doses were administered in the clinic; fourth and fifth doses were administered at home. The primary endpoint was the proportion of successful administrations of tezepelumab. Secondary endpoints included the functionality and performance of the devices, Asthma Control Questionnaire (ACQ)-6 score, pharmacokinetics and safety.
RESULTS
Overall, 216 patients were randomized (APFS, n=111; AI, n=105). Tezepelumab was successfully administered via APFS by 91.7% of the participants (100/109) and via AI by 92.4% (97/105). Overall, 95.4-97.1% of at-home administrations were successful across device groups. Malfunction occurred in 6 of 655 dispensed APFSs and 5 of 624 dispensed AIs. Clinically meaningful improvements in ACQ-6 score were observed after 24 weeks in 81.1% and 76.2% of the patients in the APFS and AI groups, respectively. Tezepelumab pharmacokinetics were consistent between device groups and with previous studies. The most common adverse event was nasopharyngitis (9.3%). Injection-site reactions occurred in 5.7% and 0% of the patients in the AI and APFS groups, respectively.
CONCLUSION
This study demonstrated that the APFS and AI were functional and reliable, and performed equally well at home and in the clinic.
背景
tezepelumab是一种正在研发的抗胸腺基质淋巴细胞生成素单克隆抗体，用于治疗重度哮喘。本研究评估了一种配套预充式注射器（APFS）和一种自动注射器（AI）在临床和家庭环境中用于注射tezepelumab的功能和性能。
方法
这项3期、多中心、随机、开放标签、平行组研究（PATH-HOME，ClinicalTrials.gov标识符：NCT03968978）在年龄为12至80岁、尽管接受了中高剂量吸入性糖皮质激素加至少一种其他控制药物治疗但哮喘仍未得到控制的患者中进行。患者通过APFS或AI接受6次皮下注射剂量的210 mg tezepelumab。第一剂由医护人员注射，后续剂量由患者或护理人员注射。第一、第二、第三和最后一剂在诊所注射；第四和第五剂在家中注射。主要终点是tezepelumab成功给药的比例。次要终点包括器械的功能和性能、哮喘控制问卷（ACQ）-6评分、药代动力学和安全性。
结果
总体而言，216例患者被随机分组（APFS组，n = 111；AI组，n = 105）。91.7%的参与者（100/109）通过APFS成功注射了tezepelumab，92.4%（97/105）的参与者通过AI成功注射。总体而言，各器械组在家中给药的成功率为95.4%至97.1%。在655支已发放的APFS中有6支出现故障，在624支已发放的AI中有5支出现故障。APFS组和AI组分别有81.1%和76.2%的患者在24周后观察到ACQ-6评分有临床意义的改善。tezepelumab的药代动力学在各器械组之间与先前的研究一致。最常见的不良事件是鼻咽炎（9.3%）。AI组和APFS组分别有5.7%和0%的患者出现注射部位反应。
结论
本研究表明，APFS和AI功能良好且可靠，在家庭和临床环境中的表现同样出色。
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