JMIR Publications

ABSTRACT

Background:

Adherence to growth hormone (GH) therapy is difficult to detect reliably. Devices such as easypod™ were developed for electronic recording of injections. The easypod™ connect observational study (ECOS) was an open-label, observational, multi-national, phase IV study conducted in 24 countries around the world. The final results from ECOS in Taiwanese cohort were reported here.

Objective:

The study aimed to evaluate adherence and long-term outcomes of therapy in pediatric subjects using the easypod™ electromechanical device for growth hormone treatment.

Methods:

Subjects (aged 2-18 or >18 years without fusion of growth plates) administered Saizen®, recombinant human growth hormone (r-hGH, somatropin), via easypod™ electromechanical device were enrolled. The primary objective was to assess the level of adherence in subjects receiving Saizen® (somatropin) via easypodTM.

Results:

In Taiwan, a total of 35 and 13 children fulfilled the criteria of full analysis set (FAS) and complete analysis set (CAS), respectively. The mean (SD) age of the CAS was 12.08 (2.72) years. All subjects were GH-naïve, with 38.5% female. The mean adherence rates were 87.6% at 3 months, 84.3% at 6 months, 81.0% at 9 months, and 91.6% at 1 year. After one year of treatment, subjects had a median (Q1:Q3) change in height standard deviation score (SDS) of +0.30 (0.06:0.48), median height velocity of 6.50 cm/year (4.33:8.24), and median change in height velocity SDS of 1.81 (-0.04:3.52).

Conclusions:

Using easypod™ device, patients with inadequate adherence and with poor response to treatment can be identified. Adherence to GH therapy administered via easypod™ was generally high over the first year of treatment and gradually decreased over time. Overall, growth outcomes after one year indicated a positive growth response to GH treatment. Future efforts should be focused on personalized management of adherence using easypod™ system.