The EasypodTM Connect Observational Study (ECOS): Adherence Rates Before and After Study Enrollment

Program: Abstracts - Orals, Featured Poster Presentations, and Posters
Session: SUN 624-646-Growth: Clinical Trials & Observational Studies
Clinical
Sunday, June 16, 2013: 1:45 PM-3:45 PM
Expo Halls ABC (Moscone Center)

Poster Board SUN-634
Peter Davies1, Jeremy Kirk2, Jan Lebl3, Andrea Luczay*4, Martin Borkenstein5, John VanderMeulen6, Sandro Loche7, Svante Norgren8, Ludmila Kostalova9, Ho-Seong Kim10, Juergen Zieschang11 and George Stoyanov12
1Queensland Children's Medical Research Institute, Australia, 2Birmingham Children's Hospital, Birmingham, United Kingdom, 3Charles University, Prague 5, Czech Republic, 4Semmelweis University, Budapest, Hungary, 5Medical University of Graz, Graz, Austria, 6McMaster Children's Hospital and McMaster University, Hamilton, Canada, 7Servizio di Endocrinologia Pediatria, Ospedale Microcitemico, Cagliari, Italy, 8Karolinska University Hospital, Stockholm, Sweden, 9Comenius University Medical School, Bratislava, Slovakia, 10Yonsei University, Seoul, South Korea, 11Merck KGaA, Darmstadt, Germany, 12EMD Serono, Mississauga, Canada
BACKGROUND: Analysis of adherence to recombinant human growth hormone (r-hGH) therapy has, until recently, been limited by recall bias and reliance on self-reporting. Accurate recorded data on r-hGH use can now be collected from patients using the easypodTMauto-injector.

OBJECTIVES: The primary objective of the easypodTM connect observational study (ECOS) is to assess adherence in patients prescribed r-hGH via easypodTM. Adherence data collected before (retrospective) and after (prospective) study enrollment are presented to explore adherence both before and during the study.

METHODS: ECOS is a multinational observational study launched in 2010, which aims to follow pediatric patients receiving r-hGH therapy for up to 5 years, with yearly analyses. Demographic, auxological and diagnostic data are obtained from medical notes, and adherence data are uploaded from patients' auto-injectors. Adherence is defined as the number of days with injections received during study period divided by the number of days with injections planned during the study period, expressed as a percentage. Adherence rates for patients with both retrospective and prospective data available were compared using the Wilcoxon signed-rank sum test.

RESULTS: At time of analysis, 956 patients (mean [standard deviation] age 9.71 [3.85] years; 44.5% girls) had enrolled in the study. The majority (68.6%) of patients were treated for GH deficiency. Patients with available prospective data demonstrated high median (Q1;Q3) adherence rates that were maintained over time (Months 1–3]: 95.3% [86.4; 98.9], n=416; Months 3–6: 96.2% [85.7, 98.9], n=270; Months 6–9: 95.6% [83.5, 98.9], n=149). Patients with both retrospective and prospective data available demonstrated median (Q1;Q3) adherence rates before and after study enrollment of: 94.5% (83.5; 98.9) vs 93.4% (84.6; 98.9) up to Month 3 (n=202, p=0.857); 89.0% (75.6; 97.1) vs 91.8% (81.1; 97.8) up to Month 6 (n=100, p=0.208); and 85.0% (51.5; 94.1) vs 89.0% (70.7; 97.1) up to Month 9 (n=52, p=0.209).

CONCLUSIONS: In patients receiving r-hGH via an auto-injector, adherence rates were high (median values >95%) during the study and were maintained over 9 months. Adherence rates for patients with both retrospective and prospective data available reveal no significant difference in adherence before and after study enrollment over comparable time points.

Disclosure: PD: Planning Group Member, Merck Serono, Investigator, Merck Serono. JK: Speaker, Merck Serono, Investigator, Merck Serono, Planning Group Member, Merck Serono. JL: Investigator, Merck Serono, Planning Group Member, Merck Serono. AL: Investigator, Merck Serono, Planning Group Member, Merck Serono. MB: Planning Group Member, Merck Serono, Investigator, Merck Serono. JV: Investigator, Merck Serono, Planning Group Member, Merck Serono. SL: Speaker, Merck Serono, Investigator, Merck Serono, Planning Group Member, Merck Serono. SN: Planning Group Member, Merck Serono, Investigator, Merck Serono. LK: Investigator, Merck Serono, Planning Group Member, Merck Serono. HSK: Investigator, Merck Serono, Planning Group Member, Merck Serono. JZ: Employee, Merck KGaA. GS: Employee, EMD Serono.

*Please take note of The Endocrine Society's News Embargo Policy at http://www.endo-society.org/endo2013/media.cfm

Sources of Research Support: This study was supported by Merck KGaA Australia, Czech Republic, France, Greece, Hungary, Italy, Slovakia, Sweden, UK, all affiliates of Merck KGaA, Darmstadt, Germany.