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. 2022 Jan 20;10(1):e32626.
doi: 10.2196/32626.

Adherence to Growth Hormone Treatment Using a Connected Device in Latin America: Real-World Exploratory Descriptive Analysis Study

Aria Assefi  1 , Paula van Dommelen  2 , Lilian Arnaud  3 , Carlos Otero  4 , Luis Fernandez-Luque  5 , Ekaterina Koledova  6 , Luis Eduardo Calliari  7
Affiliations

Adherence to Growth Hormone Treatment Using a Connected Device in Latin America: Real-World Exploratory Descriptive Analysis Study

Aria Assefi et al. JMIR Mhealth Uhealth. .

Abstract

Background: Recombinant human growth hormone (rhGH) therapy is an effective treatment for children with growth disorders. However, poor outcomes are often associated with suboptimal adherence to treatment.

Objective: The easypod connected injection device records and transmits injection settings and dose data from patients receiving rhGH. In this study, we evaluated adherence to rhGH treatment, and associated growth outcomes, in Latin American patients.

Methods: Adherence and growth data from patients aged 2-18 years from 12 Latin American countries were analyzed. Adherence data were available for 6207 patients with 2,449,879 injections, and growth data were available for 497 patients with 2232 measurements. Adherence was categorized, based on milligrams of rhGH injected versus milligrams of rhGH prescribed, as high (≥85%), intermediate (>56%-<85%), or low (≤56%). Transmission frequency was categorized as high (≥1 per 3 months) or low (<1 per 3 months). Chi-square tests were applied to study the effect of pubertal status at treatment start and sex on high adherence, and to test differences in frequency transmission between the three adherence levels. Multilevel linear regression techniques were applied to study the effect of adherence on observed change in height standard deviation score (∆HSDS).

Results: Overall, 68% (4213/6207), 25% (n=1574), and 7% (n=420) of patients had high, intermediate, and low adherence, respectively. Pubertal status at treatment start and sex did not have a significant effect on high adherence. Significant differences were found in the proportion of patients with high transmission frequency between high (2018/3404, 59%), intermediate (608/1331, 46%), and low (123/351, 35%) adherence groups (P<.001). Adherence level had a significant effect on ∆HSDS (P=.006). Mean catch-up growth between 0-24 months was +0.65 SD overall (+0.52 SD in patients with low/intermediate monthly adherence and +0.69 SD in patients with high monthly adherence). This difference translated into 1.1 cm greater catch-up growth with high adherence.

Conclusions: The data extracted from the easypod Connect ecosystem showed high adherence to rhGH treatment in Latin American patients, with positive growth outcomes, indicating the importance of connected device solutions for rhGH treatment in patients with growth disorders.

Keywords: adherence; children; connected device; disorder; electronic injection device; growth; growth disorders; growth hormone; outcome; real-world data; therapy; treatment.

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Conflict of interest statement

Conflicts of Interest: AA is an employee of Merck SA, Buenos Aires, Argentina (an affiliate of Merck KGaA, Darmstadt, Germany). PvD has a consultancy agreement with the healthcare business of Merck KGaA, Darmstadt, Germany. LA is an employee of Ares Trading SA (an affiliate of Merck KGaA, Darmstadt, Germany). CO does not have any conflicts of interest to declare. LFL is Chief Scientific Officer at Adhera Health Inc, which has a commercial relationship with the healthcare business of Merck KGaA, Darmstadt, Germany. EK is an employee of the healthcare business of Merck KGaA, Darmstadt, Germany, and holds shares in the company. LEC has received honoraria as a lecturer from the healthcare business of Merck KGaA, Darmstadt, Germany, NovoNordisk, and Pfizer.

Figures

Figure 1
Figure 1
Participating Latin American countries.
Figure 2
Figure 2
Proportion of patients who were adherent at each time point. Adherence was recorded for the cross-section of children or their caregivers transmitting data at each time point; no imputation was made for missing data or withdrawal from the study.
Figure 3
Figure 3
Adherence at each time point stratified by nominal pubertal age and sex (A: boys, B: girls). Adherence was recorded for the cross-section of children or their caregivers transmitting data at each time point; no imputation was made for missing data or withdrawal from the study.
Figure 4
Figure 4
Catch-up growth between 0-24 months stratified by low/intermediate adherence (<85%) and high adherence (≥85%). ∆HSDS: change in height standard deviation score.
See this image and copyright information in PMC

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