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

Abstract

Purpose: To assess the usability and safety of the disposable pen compared to those of reusable devices in patients receiving recombinant human growth hormone (rhGH) treatment.

Patients and methods: This study was a multicenter, single-arm, open-label, switch-over, prospective, Phase IV trial. After screening, eligible patients who were previously treated with rhGH using a reusable device were enrolled to receive treatment with the disposable pen for 8 weeks. The ease of use, preference, and tolerability of the disposable pen compared to those of the reusable device were assessed by the subjects and/or their caregivers using a questionnaire. Adverse events were evaluated by the investigators.

Results: Of 116 subjects enrolled in this study, 115 received treatment with the disposable pen and 109 completed the study. The mean age of the subjects was 9.4 years. Compared to the previous reusable device, the disposable pen was assessed as significantly easier to use (mean value 7.88, 95% confidence interval (CI) [7.45-8.30] on a numerical scale ranging from 0 (far less easy) to 10 (far easier)). Furthermore, the percentage of subjects who preferred the disposable pen to the previously used reusable device was 75.7% (95% CI [67.6%-83.8%]). The percentages of subjects who rated pain and discomfort at the injection site as "not at all" were higher after using the disposable pen compared to the reusable device. No specific safety concerns were identified.

Conclusion: The disposable pen is easier to use than the reusable devices and is preferred by approximately 75% of patients receiving rhGH treatment. Moreover, the disposable pen is safe and acceptable. Therefore, it could be a good alternative to reusable devices. The disposable pen is expected to provide benefits to patients receiving rhGH treatment.

Clinicaltrialsgov identifier: NCT03015909.

Keywords: disposable equipment; growth hormone; patient preference; safety; usability.

Conflict of interest statement

The study was funded by LG Chem, Ltd. The sponsor was involved in the design of the study, data analysis, and reviewing the manuscript, but played no role in the collection and interpretation of data. YuJin Lee and Eun Young Kim are employees of LG Chem, Ltd. Dr Ji-Eun Lee, Dr Se Young Kim, Dr Jae-Ho Yoo, Dr Il Tae Hwang, Dr Jung Sub Lim, Dr Kyung Hee Yi, Dr Young-Jun Rhie, Dr Gyung Min Lee, Dr Hyo-Kyoung Nam, Dr Hyun Wook Chae, Dr Eun Young Kim, Dr Chong Kun Cheon, Dr Jieun Lee, Dr Young Suk Shim, and Dr Jin Soon Hwang report grants and non-financial support from LG Chem, Ltd., during the conduct of the study. The authors report no other conflicts of interest in this work.

© 2019 Lee et al.

Figures

Figure 1

Subject disposition.

Figure 2

Ease of use based on each injection step (Per protocol set). *p<0.05, p-value was obtained from Bhapkar’s test.

Figure 3

Injection preparation time (Per protocol set). The difference of the injection preparation time between the previous reusable device and the disposable pen was significant by Bhapkar’s test (p=0.0023).

Figure 4

Benefits of the disposable pen (Per protocol set). Notes: Multiple choices were allowed for each subject.

Figure 5

Fear of the needle of the reusable device and the disposable pen (Per protocol set). The difference of the fear of the needle between the previous reusable device and the disposable pen was significant by Bhapkar’s test (p=0.0025).

Figure 6

Pain and discomfort at the injection site (Safety set). The differences of the pain and discomfort at the injection site between the previous reusable device and the disposable pen were significant by Bhapkar’s test (p<0.05).