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类风湿关节炎患者中赛妥珠单抗聚乙二醇化修饰自动注射装置的比较可用性研究。

Comparative usability study for a certolizumab pegol autoinjection device in patients with rheumatoid arthritis.

作者信息

Domańska Barbara, VanLunen Brenda, Peterson Luke, Mountian Irina, Schiff Michael

机构信息

a UCB Celltech , Slough , UK.

b UCB Pharma , Raleigh , NC , USA.

出版信息

Expert Opin Drug Deliv. 2017 Jan;14(1):15-22. doi: 10.1080/17425247.2016.1256283. Epub 2016 Nov 18.

Abstract

OBJECTIVES

To compare the usability of a new certolizumab pegol (CZP) autoinjector with the adalimumab, etanercept, and golimumab devices in patients with rheumatoid arthritis.

METHODS

Two identical studies were performed in 2013 and 2016; patients performed a simulated self-injection with the CZP autoinjector and the most up-to-date device versions at the time in a randomized, consecutive sequence. The primary end point was the ranking of the four autoinjectors in order of preference. Device usability and intuitiveness were assessed across a range of secondary and exploratory end points.

RESULTS

The 2013 and 2016 study populations included 76 patients each; a significant majority (2013: 67%; 2016: 59%) ranked the CZP autoinjector as their most preferred device (p < 0.001). Most patients agreed that the CZP autoinjector was easier to use, start, and manipulate, and were more willing to use it than the comparator devices (p < 0.001 for all pairwise comparisons with CZP). Likert score differences also favored the CZP autoinjector regarding how easy it was to determine injection completion. The CZP autoinjector was associated with a low rate of use error.

CONCLUSIONS

In both studies, the CZP autoinjector was the preferred choice compared to the alternative devices and was associated with a high level of patient satisfaction.

摘要

目的

比较新型聚乙二醇化赛妥珠单抗(CZP)自动注射器与阿达木单抗、依那西普和戈利木单抗装置在类风湿性关节炎患者中的易用性。

方法

在2013年和2016年进行了两项相同的研究;患者以随机、连续的顺序使用CZP自动注射器和当时最新的装置版本进行模拟自我注射。主要终点是以偏好顺序对四种自动注射器进行排名。在一系列次要和探索性终点中评估装置的易用性和直观性。

结果

2013年和2016年的研究人群各包括76名患者;绝大多数(2013年:67%;2016年:59%)将CZP自动注射器列为他们最喜爱的装置(p < 0.001)。大多数患者一致认为,CZP自动注射器更易于使用、启动和操作,并且比对照装置更愿意使用(与CZP的所有成对比较中p < 0.001)。关于确定注射完成的难易程度,李克特评分差异也有利于CZP自动注射器。CZP自动注射器的使用错误率较低。

结论

在两项研究中,与其他装置相比,CZP自动注射器都是首选,并且患者满意度很高。

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