The Easypod Connect Observational Study (ECOS) assessed real-time adherence in patients from 24 countries who were receiving recombinant human growth hormone (r-hGH; Saizen®) via easypod, which is an electronic injection device. Overall, ECOS showed mean adherence was maintained at ~80% for up to 3 years. Here, we assess the adherence to r-hGH administered via easypod in the Argentinian cohort of patients from ECOS (NCT01582334).
Patients aged 218 years treated with r-hGH administered via easypod for ≥6 months and ≥5 years, with a documented start date were eligible. Good adherence (proportion of days with injection received/days with injections planned) was defined as ≥80%. Growth outcomes (change in height standard deviation score [SDS] and change in height velocity SDS) and trends between adherence and growth outcomes were secondary outcomes. Adherence data were downloaded from the easypod device; demographic, auxological and diagnostic data were taken from medical notes. All analyses were descriptive.
Sixty-eight patients overall were included in the observational multicenter study (median age 11 years, 71% male and 29% female); 63 patients with adherence data for the 3 months after starting treatment were included in the easypod adherence data analysis set. The patient diagnoses were: 44 had growth hormone deficiency (GHD), 11 were small for gestational age (SGA) and eight had Turner syndrome (TS); 33 were growth hormone naïve. After 1 year of treatment, median (Q1:Q3) adherence in the easypod adherence data analysis set (N=49) was 88.5% (67.9%:95.6%). Good adherence decreased each year but was maintained to 3 years: 81.0% (53.2%:93.5%); N=17. After 1 year, the median (Q1;Q3) change in height SDS was 0.43 (0.21;0.64) and the change in height velocity SDS was 2.02 (0.33;4.30). Sub-analysis of adherence and growth outcomes at 1 year in patients with no missing data and no gaps in treatment >1 week (N=22) produced similar results: change in height SDS was 0.45 (0.21;0.64) and change in height velocity SDS was 2.15 (0.61;4.30). One-year growth outcomes in r-hGH treatment-naïve patients showed variable outcomes based on the origin of GHD. There was a positive trend between adherence and change in height SDS at 1 year for patients with GHD, although the number of patients was small (n=44).
In agreement with the results from the global analyses of ECOS, treatment with r-hGH administered via easypod led to high adherence rates in this representative population from Argentina. Overall, 1-year growth outcomes were clinically meaningful.
19 - 21 Sep 2019
European Society for Paediatric Endocrinology