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.

中文翻译：

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在墨西哥，对生长激素缺乏症，小胎龄和特纳综合征的儿童坚持治疗：Easypod™连接观察研究（ECOS）的结果。

背景

评估对生长激素（GH）的依从性具有挑战性。Easypod™连接设备可提供预设剂量的重组人GH（r-hGH），并存储可与医疗保健提供者共享的依从性数字记录。我们根据r-hGH的批准儿科适应症评估了Easypod™所提供的r-hGH的依从性：生长激素缺乏症（GHD），生于胎龄小（SGA），未能表现出追赶性生长和特纳综合征（TS） ）。

方法

ECOS（NCT01555528）是一个多中心（24个国家/地区）的为期5年的纵向观察性研究，旨在评估通过Easypod™电子注射设备对特定国家/地区对r-hGH治疗的依从性。主要终点是每年的依从性。次要终点为身高速度，身高速度标准差评分（SDS），身高，身高SDS和IGF-1浓度。临床和生理学数据来自医疗记录，并来自Easypod™日志。

结果

这项研究纳入了147名Easypod™天真的墨西哥儿童，他们在3年内进行了评估（平均年龄：9.96±3.41岁，男孩为56.8％，基线时的平均身高SDS：− 2.17±0.97）：GHD为118，SGA为24，TS为5。共有105例（71.4％）的GH为纯稚患者。在治疗的第一年，总体中位依从性> 90％，在3年时> 80％。依r-hGH指示或未接受GH或有经验的患者之间的依从性没有差异。在一年的随访中，身高SDS的平均变化为0.57±0.34，而身高速度SDS的平均变化为2.85±2.51。在1年的随访中，共有84.7％的患者的IGF-1浓度正常。附着力与身高SDS（r  = 0.239，p  = 0.005）和身高速度SDS（r  = 0.194，p = 0.027）。

结论

Easypod™设备的粘附率很高，并且在墨西哥GHD，SGA和TS Easypod™初次使用的患者中随时间保持不变。高依从性与更好的结果相关。Easypod™协助医生监测对r-hGH的依从性。