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)

• Published in: Journal of endocrinological investigation Vol. 43; no. 10; pp. 1447 - 1452
• Main Authors: Blanco-López, A., Antillón-Ferreira, C., Saavedra-Castillo, E., Barrientos-Pérez, M., Rivero-Escalante, H., Flores-Caloca, O., Calzada-León, R., Rosas-Guerra, C. C., Koledova, E., Chiquete, E., Ayala-Estrada, A.
• Format: Journal Article
• Language: English
• Published: Cham Springer International Publishing 01.10.2020; Springer Nature B.V
• Subjects: Age; Children; Endocrinology; Genetic disorders; Gestational age; Growth hormones; Insulin-like growth factor I; Internal Medicine; Medical records; Medicine; Medicine & Public Health; Metabolic Diseases; Observational studies; Original; Original Article; Patients; Physical growth; Small for gestational age; Turner's syndrome; Velocity; Mexico; Adherence; Somatotropin; Auto-injector; Growth hormone; Device
• ISSN: 1720-8386; 0391-4097; 1720-8386
• DOI: 10.1007/s40618-020-01218-4

Background Assessing adherence to growth hormone (GH) is challenging. The Easypod™ connect device delivers pre-set 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.