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Adherence to Growth Hormone Treatment Using a Connected Device in Latin America: Real-World Exploratory Descriptive
Aria Assefi1, Paula van Dommelen2, Lilian Arnaud3
1Fertility and Endocrinology, Merck SA (an affiliate of Merck KGaA, Darmstadt, Germany), Buenos Aires, Argentina.
Insights
High adherence to recombinant human growth hormone (rhGH) therapy in Latin American children, tracked by connected devices, correlated with better growth outcomes. This highlights the value of technology in improving treatment for growth disorders.
Area of Science:
- Pediatric Endocrinology
- Biotechnology
- Medical Device Technology
Background:
- Recombinant human growth hormone (rhGH) therapy is crucial for treating pediatric growth disorders.
- Suboptimal patient adherence to rhGH treatment is a significant barrier to achieving positive therapeutic outcomes.
- Connected injection devices offer a potential solution for monitoring and improving adherence.
Purpose of the Study:
- To evaluate adherence to rhGH treatment among Latin American pediatric patients using the easypod connected injection device.
- To assess the association between rhGH treatment adherence and patient growth outcomes in this population.
- To determine the impact of connected device data on understanding treatment effectiveness.
Main Methods:
- Analysis of adherence and growth data from 6207 pediatric patients (aged 2-18) across 12 Latin American countries.
- Categorization of adherence levels (high, intermediate, low) based on prescribed versus injected rhGH doses.
- Statistical analysis, including chi-square tests and multilevel linear regression, to evaluate factors influencing adherence and growth (∆HSDS).
Main Results:
- Overall adherence was high, with 68% of patients classified as highly adherent (≥85%).
- High adherence was significantly associated with higher transmission frequency from the connected device (59% vs. 46% and 35%).
- Higher adherence levels demonstrated a significant positive effect on height standard deviation score change (∆HSDS), resulting in an average of 1.1 cm greater catch-up growth.
Conclusions:
- Connected device technology, exemplified by the easypod ecosystem, facilitates high adherence to rhGH therapy in Latin American pediatric patients.
- Demonstrated high adherence correlates with improved growth outcomes, underscoring the clinical utility of these devices.
- Connected solutions are vital for optimizing rhGH treatment and improving management of growth disorders in pediatric populations.
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.
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