Adherence and long-term outcomes of growth hormone therapy with easypod™ in pediatric subjects: Spanish ECOS study

Abstract

Background Non-adherence to r-hGH treatments occurs in a variable percentage of subjects. One problem found when evaluating adherence is the great variability in methods of detection and definitions utilized in studies. This study assessed the level of adherence in subjects receiving r-hGH with the easypod™ electronic device. Methods National, multicenter, prospective and observational study involving 238 subjects (144 with GH deficiency (GHD), and 86 with small for gestational age (SGA), 8 with Turner Syndrome), who received r-hGH with easypod™ for at least 3 months before inclusion. The follow-up period was 4 years. Results Overall adherence was 94.5%; 97.5% after 6 months, 95.3% after 1 year, 93.7% after 2, 94.4% after 3 and 95.5% after 4 years of treatment. No differences in adherence were observed between prepubertal and pubertal groups and GHD and SGA groups. Change in height after 1 and 2 years, change in height SDS after 1 and 2 years, HV after 1 year, HV SDS after at 1 and 4 years, change in BMI after 1 year and change in BMI SDS at 1 and 2 years showed significant correlation with adherence. No significant differences in adherence according to IGF-I levels were found in follow-up visits or between groups. Conclusions The easypod™ electronic device, apart from being a precise and objective measure of adherence to r-hGH treatment, allows high compliance rates to be achieved over long periods of time. Adherence significantly impacts growth outcomes associated with r-hGH treatment.

Adherence to treatment in children with growth hormone deficiency, small for gestational age and Turner syndrome in Mexico: results of the Easypod™ connect observational study (ECOS)

“…In the present study, the observed adherence rate was above 80% up to 3 years of clinical follow-up, which contrasts with the expected adherence rate of 55–65% observed in other studies using different r-hGH delivery technologies [ 22 , 23 ] and confirms the findings of other reports with the same methodology [ 5 , 6 , 13 , 14 , 24 ]. Additionally, this study suggests that adherence to therapy is predictor of clinical response, a factor that has been described in other scenarios where electromechanical auto-injectors are used to deliver drugs and to assess compliance to therapy [ 25 − 30 ].…”

Digital Health for Supporting Precision Medicine in Pediatric Endocrine Disorders: Opportunities for Improved Patient Care

“…The multi-national easypod connect observational study (ECOS) assessed adherence among pediatric patients using the easypod connect system for GH therapy for up to 5 years. Adherence was ≥80% for more than 3 years for results overall and for several individual countries, and analyses showed significant associations between poor adherence and impaired clinical outcomes (112)(113)(114)(115)(116)(117). Adherence rates for patients new to GH therapy and those already receiving GH did not differ, and there was no difference between diagnoses (112).…”

Monitoring Adherence Rate to Growth Hormone Therapy and Growth Outcomes in Taiwanese Children Using Easypod Connect: Observational Study

“…The ECOS assessed the adherence to recombinant human growth hormone treatment as well as growth outcomes in pediatric patients with growth disorders. The results of the European and American countries involved in this open-label, observational, longitudinal study have been published [ 20 - 22 ]. To our knowledge, there is no literature exploring the adherence to growth hormone treatment in Taiwanese or Chinese pediatric patients in a real-life setting, especially by using an electronic monitoring method.…”

“…The results of the ECOS have been published by Koledova et al [ 19 ]. Among the countries involved, the results of Spain [ 20 ], Italy [ 21 ], and Mexico [ 22 ] have been published. However, there is no related publication in the Asia-Pacific region.…”