https://orcid.org/0000-0002-7386-0015
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.
Clinicaltrials.gov identifier
NCT03015909.
Acknowledgments
The study was funded by LG Chem, Ltd. The affiliation of Gyung Min Lee was changed after this work, and the current affiliation is Lee Gyung Min Pediatrics, Daejeon, Republic of Korea. The authors acknowledge the efforts of all the investigators, site staffs, subjects, and caregivers who devoted their time and energy to this trial. The authors thank Yunae Eom of LG Chem, Ltd., for writing assistance in preparing the manuscript.
Abbreviations
CI, confidence interval; CRF, chronic renal failure; GHD, growth hormone deficiency; ISS, idiopathic short stature; rhGH, recombinant human growth hormone; SD, standard deviation; SGA, small for gestational age; TS, Turner syndrome.
Ethics Approval and Informed Consent
The study was approved by the institutional review board at 15 study sites. Written informed consent was obtained from all individual participants and their legally authorized representatives.
The full title of each institution and the corresponding ethical review board is as follows:
Inha University Hospital: Inha University Hospital Institutional Review Board
Bundang Jeseang General Hospital: Institutional Review Board of Bundang Jeseang General Hospital
Dong-A University Hospital: Institutional Review Board of Dong-A University Hospital
Kangdong Sacred Heart Hospital: Kangdong Sacred Heart Hospital Institutional Review Board
Korea Cancer Center Hospital: Korea Institute of Radiological & Medical Sciences Institutional Review Board
Wonkwang University Sanbon Medical Center: Institutional Review Board of Wonkwang University Sanbon Hospital
Korea University Ansan Hospital: Institutional Review Board of Korea University Ansan Hospital
Konyang University Hospital: Konyang University Hospital Institutional Review Board
Korea University Guro Hospital: Institutional Review Board of Korea University Guro Hospital
Gangnam Severance Hospital: Institutional Review Board of Gangnam Severance Hospital
Chosun University Hospital: Chosun University Hospital Institutional Review Board
Pusan National University Children’s Hospital: Institutional Review Board of Pusan National University Yangsan Hospital
Inje University Ilsan Paik Hospital: Inje University Ilsan Paik Hospital Institutional Review Board
Hallym University Dongtan Sacred Heart Hospital: Hallym University Dongtan Sacred Heart Hospital Institutional Review Board
Ajou University Hospital: Institutional Review Board of Ajou University Hospital
Data Sharing Statement
The data supporting the findings of the study are available from the corresponding author on reasonable request.
Author Contributions
Ji-Eun Lee contributed to the data interpretation and wrote the manuscript. YuJin Lee supported conducting the study, and contributed to conception and design and project administration. Eun Young Kim of LG Chem, Ltd. contributed to the data analysis. All authors, except YuJin Lee and Eun Young Kim of LG Chem, Ltd., contributed to investigation and acquisition of data. All authors contributed to drafting or revising the article, gave final approval of the version to be published, and agree to be accountable for all aspects of the work.
Disclosure
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.