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

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.

The adult growth hormone multicentric retrospective observational study: a 24-month Italian experience of adherence monitoring via Easypod™ of recombinant growth hormone treatment in adult GH deficiency

“…Our data confirmed low adherence in aGHD population on rhGH treatment (6). Mean adherence in the whole population was nearly 73% after two years of observation, far inferior to those of pediatric population collected by the ECOS studies (15)(16)(17)(18)(19)(20). This could be explained given the different treatment results gained in pediatric versus aGHD: on one hand, height gain is an evident and…”

“…Koledova et al confirmed the indication in children with short stature treated with rhGH, as the value is related to better growth outcomes (18). Meanwhile, other studies chose 85% as the threshold for "good adherence", and 56% as the threshold for inadequate adherence (20). As above stated, noncompliance is one of the most important causes of chronic treatment failure.…”

“…The threshold rate for high adherence was set as ≥85%, while low adherence was defined as ≤ 56%. Intermediate adherence was considered between 56 and 85% (20).…”

“…While several data on children affected by GHD have been collected (15)(16)(17)(18)(19)(20), no multicentric data of aGHD adherence are currently reported in the literature. Therefore, the aim of the present multicentric observational study was to provide realworld adherence data collected via Easypod ™ in a large cohort of aGHD patients, and ultimately to correlate adherence data with clinical outcomes in such patients.…”

Evaluating the TUITEK® patient support program in supporting caregivers of children diagnosed with growth hormone deficiency in Argentina

“…Several studies have examined the prevalence of nonadherence among children and adolescents with clinical indications for r-hGH treatment, including GHD, Turner syndrome, small for gestational age (SGA), and chronic renal failure (CRF), and reported that up to 71% and 82% of children and adolescents, respectively, were nonadherent to their treatment (1,9). Poor adherence to the r-hGH treatment negatively affects both long-term clinical outcomes (leading to suboptimal growth outcomes) (9,(11)(12)(13)(14) and healthcare system cost and resources (10,(15)(16)(17)(18). Living with GHD can be both physically and emotionally challenging for the patient and their family (11,(19)(20)(21)(22).…”