Adherence to treatment in children with growth hormone deficiency, small for gestational age and Turner syndrome in Mexico: results of the Easypod™ connect observational study (ECOS)

Abstract

Background Assessing adherence to growth hormone (GH) is challenging. The Easypod™ connect device delivers preset doses of recombinant human GH (r-hGH) and stores a digital record of adherence that can be shared with healthcare provider. We assessed adherence to r-hGH delivered with Easypod™ according to the approved pediatric indications for r-hGH: growth hormone deficiency (GHD), born small for gestational age (SGA) who failed to show catch-up growth and Turner syndrome (TS). Methods ECOS (NCT01555528) was a multicenter (24 countries), 5-year, longitudinal, observational study, which aimed to evaluate country-specific adherence to r-hGH therapy prescribed via the Easypod™ electronic injection device. The primary endpoint was yearly adherence. Secondary endpoints were height velocity, height velocity standard deviation scores (SDS), height, height SDS and IGF-1 concentrations. Clinical and auxological data were obtained from medical records and adherence from Easypod™ logs. Results This study included 147 Easypod™-naïve Mexican children assessed during 3 years (mean age: 9.96 ± 3.41 years, 56.8% boys, mean height SDS at baseline: − 2.17 ± 0.97): 118 with GHD, 24 SGA and 5 with TS. A total of 105 (71.4%) patients were GH naïve. Overall median adherence was > 90% over the first year of treatment and > 80% at 3 years. Adherence was not different by r-hGH indication or between GH-naïve or experienced patients. At 1-year follow-up, mean change in height SDS was 0.57 ± 0.34, whereas mean height velocity SDS was 2.85 ± 2.51. In all, 84.7% patients had normal IGF-1 concentrations at 1-year follow-up. Adherence was associated with change in height SDS (r = 0.239, p = 0.005) and height velocity SDS (r = 0.194, p = 0.027). Conclusion Adherence rates with the Easypod™ device are high and maintained over time in GHD, SGA and TS Easypod™naïve Mexican patients. High adherence is associated with better outcomes. Easypod™ assists physicians in monitoring adherence to r-hGH.

Digital Health for Supporting Precision Medicine in Pediatric Endocrine Disorders: Opportunities for Improved Patient Care

“…The multi-national easypod connect observational study (ECOS) assessed adherence among pediatric patients using the easypod connect system for GH therapy for up to 5 years. Adherence was ≥80% for more than 3 years for results overall and for several individual countries, and analyses showed significant associations between poor adherence and impaired clinical outcomes (112)(113)(114)(115)(116)(117). Adherence rates for patients new to GH therapy and those already receiving GH did not differ, and there was no difference between diagnoses (112).…”

Connected health for growth hormone treatment research and clinical practice: learnings from different sources of real-world evidence (RWE)—large electronically collected datasets, surveillance studies and individual patients’ cases

“…ECOS also demonstrated statistically significant Spearman's product-moment correlations between adherence and 1-year change in height standard deviation score (0.11; p < 0.001 for patients overall) and height velocity (0.14; p < 0.001) [23]. Assessments of data from ECOS cohorts in a number of countries have demonstrated similar results, despite differences in the health systems in the various countries involved [30,31].…”

Monitoring Adherence Rate to Growth Hormone Therapy and Growth Outcomes in Taiwanese Children Using Easypod Connect: Observational Study

“…The ECOS assessed the adherence to recombinant human growth hormone treatment as well as growth outcomes in pediatric patients with growth disorders. The results of the European and American countries involved in this open-label, observational, longitudinal study have been published [ 20 - 22 ]. To our knowledge, there is no literature exploring the adherence to growth hormone treatment in Taiwanese or Chinese pediatric patients in a real-life setting, especially by using an electronic monitoring method.…”

“…The results of the ECOS have been published by Koledova et al [ 19 ]. Among the countries involved, the results of Spain [ 20 ], Italy [ 21 ], and Mexico [ 22 ] have been published. However, there is no related publication in the Asia-Pacific region.…”