Abstract
BackgroundAssessing 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).MethodsECOS (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.ResultsThis 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).ConclusionAdherence 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.
Highlights
The human recombinant growth hormone (h-rGH) is indicated to treat clinical conditions that imply short stature, such as GH deficiency (GHD), children born small for gestational age (SGA) who failed to show catch-up growth and Turner syndrome (TS), among other medical conditions [1,2,3,4,5,6]
EasypodTM is integrated into an e-Health ecosystem for management of growth disorders treated with Saizen (r-hGH) available to healthcare professionals through a personal-data secure web solution
Overall median adherence was >90% over the first year of treatment and >80% over 3 years (Fig. 1); as this was an observational study in Mexico and most patients were treated privately significant study dropouts where observed after the first year of therapy on patients enrolled
Summary
The human recombinant growth hormone (h-rGH) is indicated to treat clinical conditions that imply short stature, such as GH deficiency (GHD), children born small for gestational age (SGA) who failed to show catch-up growth and Turner syndrome (TS), among other medical conditions [1,2,3,4,5,6]. EasypodTM device delivers pre-set doses of r-hGH (Saizen®) and stores a digital record of adherence to therapy that can be electronically shared with healthcare providers for evaluation [5, 6, 13−21]. The EasypodTM 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 EasypodTM 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).
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