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首页> 外文期刊>Patient Preference and Adherence >Comparison between prefilled syringe and autoinjector devices on patient-reported experiences and pharmacokinetics in galcanezumab studies
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Comparison between prefilled syringe and autoinjector devices on patient-reported experiences and pharmacokinetics in galcanezumab studies

机译：galcanezumab研究中预充式注射器和自动注射器装置在患者报告的经验和药代动力学方面的比较

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Purpose: The aim of this study was to compare the usability and patient-rated experiences of an autoinjector with a prefilled syringe in patients with migraine, who self-administered galcanezumab, and to compare pharmacokinetic parameters between these devices. Materials and methods: Patient-rated experiences with an investigational autoinjector and a prefilled syringe were compared in an open-label, 12-month study of once-monthly injections of galcanezumab 120 or 240?mg (NCT02614287). Patient-rated ease of usability was assessed with the Subcutaneous Administration Assessment Questionnaire (SQAAQ) and compared between devices. Positive responses on the SQAAQ were rated as “agree or strongly agree” to 12 statements. Tolerability was assessed by the frequency of injection-site-related adverse events (AEs) by device and injection location. In a separate study, galcanezumab pharmacokinetics in healthy subjects was compared between the devices (NCT02836613). Results: In the open-label clinical trial, 179 patients used both the prefilled syringe and autoinjector at least once. The majority of patients (91%–97%) had positive responses on the SQAAQ to the use of autoinjector across the items assessed. There were 23 injection-site-related AEs with the first self-administered injection with the prefilled syringe (N=7) or autoinjector (N=16; P =0.061), with the most common AE for either device being injection-site pain. There were no significant between-device differences in injection-site-related AEs. For pharmacokinetics, the 90% CI for the ratio (autoinjector/prefilled syringe) of geometric least-square means for the galcanezumab area under the curve (AUC) concentration and maximum concentration (Cmax) was between 0.8 and 1.25, indicating no statistically significant difference in the galcanezumab concentrations regardless of the device used. Conclusion: The ease of usability with either device was comparable, and there were no significant differences in tolerability between the prefilled syringe and autoinjector with the first self-administration; however, the analysis was not powered to detect a clinically significant difference. Galcanezumab pharmacokinetics were comparable between devices.
机译：目的：这项研究的目的是比较自动注射加预充式注射器在偏头痛患者中的使用率和患者评价的经验，这些患者自行服用galcanezumab，并比较这两种设备之间的药代动力学参数。材料和方法：在开放标签的12个月研究中，每月一次注射galcanezumab 120或240mg（NCT02614287），对患者使用自动注射注射器和预装注射器的经验进行了比较。使用皮下给药评估问卷（SQAAQ）对患者评估的易用性进行了评估，并在设备之间进行了比较。在SQAAQ上，对12项声明的积极回应被评为“同意或强烈同意”。通过设备和注射位置，通过注射部位相关不良事件（AE）的频率评估耐受性。在另一项研究中，比较了两种设备之间健康受试者的galcanezumab药代动力学（NCT02836613）。结果：在开放标签的临床试验中，有179名患者至少使用一次预填充注射器和自动注射器。大多数患者（91％–97％）对SQAAQ的所有项目中使用自动注射器的反应均呈阳性。有23种与注射部位相关的AE，其中首次使用预填充注射器（N = 7）或自动注射器（N = 16; P = 0.061）进行自我管理注射，其中两种设备最常见的AE是注射部位疼痛。在注射部位相关的不良事件中，装置间无显着差异。对于药代动力学，曲线（AUC）浓度和最大浓度（Cmax）下的galcanezumab面积的几何最小二乘法均值（自动注射器/预填充注射器）的90％CI在0.8和1.25之间，表明没有统计学上的显着差异galcanezumab的浓度与使用的装置无关。结论：这两种设备的易用性均具有可比性，并且在首次自我给药后，预填充注射器和自动注射器之间的耐受性没有显着差异;但是，该分析无法检测出临床上的显着差异。在不同装置之间，Galcanezumab的药代动力学相当。

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