Results from an international multicenter trial evaluating the ease-of-use of and preference for a newly developed disposable injection pen for the treatment of growth hormone deficiency in treatment-naïve children and adults

Abstract

Previous research has reported that ease of use of and preference for a delivery device are associated with greater patient compliance – an important factor in achieving optimal therapeutic results. The objective of this study was to assess the ease-of-use of a new disposable pen (GoQuick®, Pfizer, Inc.) versus the current reusable pen (GENOTROPIN Pen®, Pfizer, Inc.) to inject a daily dose of recombinant DNA origin human growth hormone, Genotropin® (somatropin) in standard practice. In this randomized, crossover, multicenter, multinational, open-label study, ease-of-use of and preference for the two pens were assessed in three treatment-naïve populations: 1) parents of very young children; 2) parent–child dyads; and 3) adults via use of a validated self-report Injection Pen Assessment Questionnaire (IPAQ) after 2 months of at-home-use experience. The primary endpoint was the proportion of participants who reported the new disposable pen to be no different from or easier to use than the current reusable pen. Safety was also assessed and reported according to local legal requirements. Of the 120 screened patients, 119 were included in the ease-of-use analysis and all were included in the safety analyses. In all, 67.2% found the new somatropin disposable pen to be no different from or easier to use than the reusable pen (95% confidence interval: 58.8–75.7). Most adverse events were mild or moderate. No deaths or device- or treatment-related serious adverse events were reported. These results suggest that improvements made to the reusable somatropin pen are tangible and recognizable to treatment-naïve patients and their caregivers, child–caregiver dyads, and adults, and may positively impact continued compliance with therapy.Registry informationClinicalTrials.gov identifier: NCT01112865.

<p>Ease of Use, Preference, and Safety of the Recombinant Human Growth Hormone Disposable Pen Compared with the Reusable Device: A Multicenter, Single-Arm, Open-Label, Switch-Over, Prospective, Phase IV Trial</p>

“…Three-quarters (75.7%) of subjects preferred the disposable pen to the previous reusable device. This preference for the disposable pen was consistent with the results of other studies that compared a disposable pen and a reusable device 7,12. Based on the findings of this study that simple operation and less pain considered as a benefit of the disposable pen by 92.5% and 20.6% of subjects, respectively, these characteristics of the disposable pen, which provide ease of use and less pain, may have affected the preference of subjects and their caregivers.…”

“…This finding is supported by the results that most subjects (92.5%) rated simple operation (no need for cartridge replacement) as a benefit of the disposable pen, 94.4% of subjects took less than 5 mins preparing the disposable pen for injection, and the preparation time significantly shortened compared with the reusable devices. In other studies,7,12–14 the ease of use of two different injection devices was compared because the comparator was fixed. In this study, ease of use of the disposable pen was compared with those of three reusable devices by not limiting the comparator when enrolling subjects.…”

A web-based survey assessing the impact of storage flexibility on the daily life of patients and caregivers administering growth hormone

“…Several studies report that features facilitating ease of use are among the most valued aspects of a GH device [28,29] and that easy-to-use devices are generally well accepted [30][31][32][33][34][35] and identified as the device of preference [25,26]. Modification of GH injection devices to improve ease-of-use may positively influence adherence [33]. Another advantage of easy-to-use devices is that they may improve adherence by increasing the proportion of self-injecting patients [36,37].…”