Domańska Barbara, VanLunen Brenda, Peterson Luke, Mountian Irina, Schiff Michael
a UCB Celltech , Slough , UK.
b UCB Pharma , Raleigh , NC , USA.
Expert Opin Drug Deliv. 2017 Jan;14(1):15-22. doi: 10.1080/17425247.2016.1256283. Epub 2016 Nov 18.
To compare the usability of a new certolizumab pegol (CZP) autoinjector with the adalimumab, etanercept, and golimumab devices in patients with rheumatoid arthritis.
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.
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.
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.
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。
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。
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。
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。
