Evaluation of a novel pre-filled syringe for self-administration of certolizumab pegol: results from a syringe usability study

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A new syringe for the self administration of certolizumab pegol (CZP) has been designed with input from rheumatoid arthritis (RA) patients (pts), who often have limited dexterity. A 3-phase approach was used: design consideration, optimization and evaluation. The Syringe Usability Study (SUS) occurred during evaluation phase, to determine if syringe design improves pts' ability to self-administer therapy. 23 patients with mild to moderate/severe RA participated in the SUS. Pts were asked to inject CZP into fake skin using both the new and a conventional prefilled syringe (with CZP). Each syringe was quantitatively assessed for usability in a 20-item questionnaire ranking attributes on physical performance (PP; Table) and preference on a 7-point Likert-like scale (1= negative attribute, 7= positive attribute). Positive preference attributes were: this design is a step forward; this design is an improvement; and willingness to inject. A final question assessed overall syringe preference. Maximum hand grip, 2-point pinch and lateral/key pinch forces were evaluated using a MicroFet 4 dynamometer. Maximum isometric forces exerted were measured with the plunger fixed at mid-length and fully depressed using FlexiForce transducers. Attributes and differences in forces were compared using paired t-tests at confidence levels of 90% and 95%. The majority of subjects (17 out of 23) preferred the new syringe and rated it with higher scores for all 19 attributes on syringe performance and preference (15/19 were statistically significant) than the previous syringe on a 7-point Likert-like scale. Attributes scoring higher in new vs previous syringe included those relating to PP (Table) and preference (this design is a step forward [mean difference = 1.96]; this design is an improvement [mean difference = 1.91]; willingness to inject [mean difference =1.39]; all p<0.05). The new syringe design enabled pts to exert up to 48% more isometric force. Patients also achieved greater maximum dynamic forces with the new syringe over the previous syringe. The 3-phase design process culminated in the creation of a new syringe that may improve pts' ability to self-administer medication. The majority (74%) of subjects preferred the new syringe and rated higher for all performing attributes. No Caption available.

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