ESPE Abstracts (2018) 89 P-P3-197

ESPE2018 Poster Presentations GH & IGFs P3 (28 abstracts)

Adherence and Long-term Outcomes of Therapy in Pediatric Subjects in Greece Using Easypod™ Electromechanical Device for Growth Hormone Treatment: The Phase IV Multicentre Easypod™ Connect Observational Study (ECOS)

Evangelia Charmandari a , Stefanos Michalakos b , Dimitris Sakellariou c , Ekaterina Koledova d & George Chrousos a

aNational and Kapodistrian University of Athens, Athens, Greece; bP. & A. Kyriakou Children’s Hospital, Athens, Greece; cMerck S.A, Athens, Greece; dMerck KGaA, Darmstadt, Germany

The Easypod™ Connect Observational Study (ECOS) was the first global study of easypod™, currently the only electronic injection device for recombinant human growth hormone (r-hGH; Saizen®). ECOS reported accurate and robust real-time adherence data in a large cohort of patients. In this analysis, we assess the adherence of r-hGH administered via easypod™ in a cohort of Greek patients from ECOS (EMR200104-520, NCT01363674). Patients aged 2–18 years, treated with r-hGH administered via easypod™ for ≥6 months and ≤3 years, with a documented start date, and no gaps in the injection data for >1 week, were included. The primary objective was to assess the level of adherence in patients receiving r-hGH via easypod™ (proportion of days with injection received/days with injections planned; adherence was defined as ≥85%). Growth outcomes (change in height, change in height standard deviation score [SDS], height velocity and height velocity SDS), correlation between adherence and growth outcomes (Spearman product moment), and the impact of adherence on IGF-I concentrations, were assessed as secondary objectives. Adherence data were downloaded from the easypod™ device; demographic, auxological and diagnostic data were taken from medical notes. All analyses were descriptive. Overall, 180 patients were enrolled and 88 were included in the complete analysis set; 78 with growth hormone deficiency, four small for gestational age, three with Turner syndrome and three with no diagnosis (median age was 11 years, 37.5% were female and 62.5% were male), 82 patients were GH-naïve. After 1 year of treatment, median adherence was 95.5% (N=84). When analyzed over 6-month intervals, median adherence remained at approximately 90% for up to 48 months although there was no correlation between adherence and growth outcomes at 1 year. A median increase in height of 7.25 cm was reported after 1 year of treatment. The majority of patients had normal IGF-I concentrations (55 of 62 patients [88.7%]); 4 (6.5%) had abnormally low concentrations and 3 (4.8%) had abnormally high concentrations. Similar adherence levels and growth outcomes were observed in GH-naïve patients. Of the eight serious adverse events reported, six were considered unrelated to the study drug. No new safety findings were identified. Treatment with r-hGH administered via easypod led to high adherence rates in this representative population, in agreement with the results from the global analyses of ECOS. Treatment efficacy and normalization of IGF-I concentrations were noted after 1 year. Correlation could not be detected as adherence was high with low variance.

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