Background: ava® is a new reusable electromechanical auto-injector (e-Device) with disposable, single-use certolizumab pegol (CZP) dispensing cartridges.Methods: RA0098 (NCT03357471) was a US, multicenter, open-label, phase 3 study designed to assess whether the e-Device can be used safely and effectively by self-injecting patients. CZP pre-filled syringe (PFS) self-injecting patients (≥18 years) diagnosed with rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis, plaque psoriasis, and Crohn's disease received training and self-injected CZP using the e-Device at 2 visits. The primary outcome was the proportion of patients able to self-inject safely and effectively at Visit 2, defined as: 1) complete dose delivery, and 2) no adverse events related to the e-Device precluding its continued use.Results: 65/67 patients (97.0%) completed the study, 64/65 (98.5%) performed safe and effective self-injection at Visit 2, and 67/67 (100%) performed safe and effective self-injection at Visit 1. Patient satisfaction and self-confidence increased over the two visits. Overall, patients reported a preference for the e-Device (58/65; 89.2%) compared to a PFS (4/65; 6.2%).Conclusions: Patients were able to safely and effectively self-inject CZP using the e-Device and most preferred ava® over a PFS. No safety-related findings impacting the benefit-risk ratio of CZP were identified.

中文翻译：

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一项多中心，开放标签的研究，用于评估新型电动自动注射装置可安全有效地自我注射塞妥珠单抗。

背景：ava®是一种新型可重复使用的机电自动注射器（e-Device），带有一次性，一次性使用的certolizumab聚乙二醇（CZP）分配盒。方法：RA0098（NCT03357471）是美国一项多中心，开放标签的3期研究旨在评估自我注射患者是否可以安全有效地使用电子设备。CZP预装注射器（PFS）自注射的患者（≥18岁）被诊断患有类风湿性关节炎，轴向脊椎关节炎，银屑病关节炎，斑块状牛皮癣和克罗恩病，接受了培训，并在2次就诊时使用了e-Device自注射CZP。主要结局是在第2次就诊时能够安全有效地自我注射的患者比例，定义为：1）完全剂量输送； 2）没有与电子设备相关的不良事件，排除了继续使用电子设备的后果。结果：65 / 67例（97。0％）完成了研究，64/65（98.5％）在第2次就诊时进行了安全有效的自我注射，67/67（100％）在第1次就诊时进行了安全有效的自我注射。患者满意度和自信心在两次访问中增加了。总体而言，与PFS（4/65; 6.2％）相比，患者报告对e-Device的偏爱（58/65; 89.2％）。结论：患者能够安全有效地使用e-Device自我注射CZP和最优先使用的是ava®。未发现影响CZ​​P利益风险比的安全相关发现。结论：与PFS相比（2/4％； 6.2％），患者能够安全有效地使用e-Device和最喜欢的ava®自我注射CZP。未发现影响CZ​​P利益风险比的安全相关发现。结论：与PFS相比，PFS为2％）（4/65； 6.2％）。结论：与PFS相比，患者能够使用e-Device和最优选的ava®安全有效地自我注射CZP。未发现影响CZ​​P利益风险比的安全相关发现。