ESPE Abstracts (2015) 84 P-3-963

The Easypod[trade] Connect Observational Study: Comparison of Results from Interim Analyses

Peter Daviesa, Marc Nicolinob, Svante Norgrenc, George Stoyanovd, Ekaterina Koledovae & John VanderMeulenf

aChildren’s Nutrition Research Centre, Queensland Children’s Medical Research Institute, University of Queensland, Brisbane, QND, Australia; bDivision of Pediatric Endocrinology, Hôpital Femme-Mère-Enfant, Lyon, France; cDepartment of Pediatric Medicine, Karolinska University Hospital, Stockholm, Sweden; dEMD Serono, Mississauga, Canada; eMerck KGaA, Darmstadt, Germany; fFaculty of Health Sciences, McMaster Children’s Hospital and McMaster University, Hamilton, Canada

Background: The Easypod Connect Observational Study (ECOS) observational study follows children with GHD, SGA and Turner syndrome receiving r-hGH therapy for up to 5 years, with interim analyses each year. The easypod electromechanical auto-injector device enables accurate, real-world digital records of patients’ adherence to rhGH to be collected for evaluation.

Objective and hypotheses: The primary objective of ECOS is to evaluate the level of adherence of paediatric patients receiving rhGH via easypod™; secondary objectives are to assess the impact of adherence on clinical outcomes and concentrations of IGF1 and to identify factors that may influence adherence to this form of treatment.

Method: Demographic, auxological and diagnostic data are obtained from medical notes, with adherence data obtained directly from the patients’ easypod™. Adherence is defined as days with injections received, divided by days with injections planned, expressed as a percentage. An interim global analysis was completed in 2014. Interim analyses have also been completed for the Nordic countries (Norway, Sweden, Finland), France and Canada. The real-world use of easypod™ (routine visits/year, local easypod™ data upload methodology, etc) in these analyses was compared to assess any country-specific differences.

Results: At the time of analysis, 1 972 patients had been enrolled globally, mean age 9.8 years; Canada n=204, mean age 10.9 years; France n=220, 9.4 years; Nordic n=150, 8.6 years. Individual levels of adherence prospectively measured with easypod™ (median (Q1, Q3), 93.0% (82.8%, 97.5%)) were higher than those previously reported in retrospective studies based on questionnaires and were maintained over time. Median 9-month adherence rates in the countries analysed were similarly high: Canada 96.9, France 94.9, Nordic 97.3%.

Conclusion: Adherence rates with the easypod™ device are high and maintained over time. Different age range at baseline and possible differences in clinical practice did not appear to have any major impact on easypod™ adherence rates in different countries.

Conflict of interest: Professor Peter Davies has received a research grant as an investigator and honoraria as a committee member from Merck Serono.

Funding: This study is funded by Merck KGaA, Darmstadt, Germany.

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