OBJECTIVES

: ECOS (a 5-year, open-label, observational study in 24 countries, started in 2010) assessed ‘real-world’ adherence and effects on growth outcomes of children treated for growth disorders with Saizenâ recombinant human growth hormone (r-hGH, somatropin) administered by the easypod™ electronic auto-injector device. We report an interim analysis of the final results from ECOS in France (NCT01291394).

METHODS

: Data from 202 children (mean [SD] age 9.56 [3.65] years; 54% male) were available for analysis (111 GHD, 71 SGA, 18 Turner syndrome and 2 with chronic renal failure). The majority (180 [90%]) were r-hGH naïve at baseline

RESULTS

: In the global study, the majority of patients maintained ≥80% adherence over 3 years. In France, mean treatment adherence was 81% (95% CI 79-84 [81% GHD and SGA, 83.6% TS]). Adherence was ≥80% for 180 patients (89%) at 3 months, 175 (86%) at 6 months, 145 (72%) at 1 year, 93 (46%) at 2 years and 38 (19%) at 3 years.

After 1 year, r-hGH-naïve children had a median (Q1:Q3) change in height SDS of +0.45 (0.24:0.69), height velocity of 7.98 cm/year (6.80:9.13) and change in height velocity SDS of 1.89 (0.38:3.79). The Spearman’s product-moment correlation for adherence rate and change in height SDS was 0.035. Median adherence rate was ≥90% and was similar in all subgroups (e.g. age, gender, pubertal stage, self/non-self-injection and regimen). Median adherence was also >90% for patients with injections 6 days/week vs. with 7 days/week.

CONCLUSIONS

: This study in France confirms the high, sustained adherence rates with the easypod™ device noted in other results from the ECOS global study. Study cases were solicited to evaluate the impact in monitoring and these show the benefits of patient monitoring using the easypod™ device to alert the physician to potential red flags (e.g. puberty and poor family support) for on-going compliance.