Abstract
BackgroundAdherence to growth hormone therapy is difficult to detect reliably. Devices such as easypod have been developed for electronic recording of injections. The easypod connect observational study (ECOS) was an open-label, observational, multinational, phase IV study conducted in 24 countries around the world. The final results from ECOS in the Taiwanese cohort are reported in this paper.ObjectiveThis study aimed to evaluate the adherence and long-term outcomes of growth hormone therapy in pediatric subjects using the easypod electromechanical device.MethodsSubjects (aged 2-18 years or >18 years without fusion of growth plates) who received Saizen (recombinant human growth hormone, somatropin) via the easypod device were enrolled in this study. The primary objective was to assess the level of adherence in subjects receiving Saizen via easypod.ResultsIn Taiwan, a total of 35 and 13 children fulfilled the criteria of full analysis set and complete analysis set, respectively. The mean (SD) age of the complete analysis set was 12.08 (2.72) years. All subjects were growth hormone–naïve, with 38% (5/13) females. The mean adherence rates of 13 subjects were 87.6% at 3 months and 84.3% at 6 months, that of 8 subjects was 81.0% at 9 months, and that of 4 subjects was 91.6% at 1 year. After 1 year of treatment, subjects had a median (Q1:Q3) change in height SD score of 0.30 (0.06:0.48), median height velocity of 6.50 (4.33:8.24) cm/year, and median change in height velocity SD score of 1.81 (–0.04:3.52).ConclusionsWith the easypod device, patients with inadequate adherence and poor response to treatment can be identified. Adherence to growth hormone therapy administered via easypod was generally high in the first year of treatment but the adherence gradually decreased over time. Overall, growth outcomes after 1 year indicated a positive growth response to growth hormone treatment. Future efforts should be focused on personalized management of adherence by using the easypod system.
Highlights
BackgroundHuman growth hormone, known as somatotropin, is synthesized and secreted by the somatotropic cells of the anterior pituitary gland and it plays a critical role in growth and metabolism
Growth hormone is indicated for treating growth disorders due to a number of medical causes, including growth hormone deficiency, Turner syndrome, and children born small for gestational age
The easypod connect observational study (ECOS) assessed the adherence to recombinant human growth hormone treatment as well as growth outcomes in pediatric patients with growth disorders
Summary
BackgroundHuman growth hormone, known as somatotropin, is synthesized and secreted by the somatotropic cells of the anterior pituitary gland and it plays a critical role in growth and metabolism. Synthetic human growth hormone has been widely administered for the treatment of inadequate secretion of endogenous growth hormones in children and adults. Adherence to growth hormone therapy is difficult to detect reliably. Devices such as easypod have been developed for electronic recording of injections. Objective: This study aimed to evaluate the adherence and long-term outcomes of growth hormone therapy in pediatric subjects using the easypod electromechanical device. Methods: Subjects (aged 2-18 years or >18 years without fusion of growth plates) who received Saizen (recombinant human growth hormone, somatropin) via the easypod device were enrolled in this study. Adherence to growth hormone therapy administered via easypod was generally high in the first year of treatment but the adherence gradually decreased over time. Future efforts should be focused on personalized management of adherence by using the easypod system
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