ESPE Abstracts (2018) 89 P-P2-226

Adherence to Treatment in Growth Hormone Deficient and Small for Gestational Age Patients Naive to EasypodTM in Mexico: Final Results of the EasypodTM Connect Observational Study (ECOS)

Armando Blanco-Lópeza, Carlos Antillón-Ferreirab, Eloisa Saavedra-Castilloc, Margarita Barrientos-Pérezd, Héctor Rivero-Escalantee, Oscar Flores-Calocaf, Raúl Calzada-Leóng, Carmen Celeste Rosas-Guerrah, Ekaterina Koledovai & Arturo Ayala-Estradaj

aHospital Ángeles Interlomas & Hospital Español, México City, Mexico; bHospital Español, México City, Mexico; cHospital de la Oca, Monterrey, Nuevo León, Mexico; dHospital Ángeles, Puebla, Puebla, Mexico; ePrivate Practice, Cancún, Quintana Roo, Mexico; fHospital Zambrano-Elion, Monterrey, Nuevo León, Mexico; gInstituto Nacional de Pediatría, México City, Mexico; hMerck S.A. de C.V., Naucalpan de Juárez, Mexico; iMerck KGaA, Darmstadt, Germany; jServicio de Pediatría Hospital ISSEMyM, Toluca, Estado de México, Mexico.

Background: The easypodTM auto-injector is designed to make daily administration of recombinant human growth hormone (r-hGH) comfortable and easier to patients. EasypodTM device delivers pre-set doses of r-hGH (Saizen®) and stores a digital record of adherence to therapy that can be shared with healthcare providers for evaluation.

Objective: To assess adherence to r-hGH therapy delivered via the easypodTM device in easypodTM-naïve patients according to the approved pediatric indications for Saizen® in Mexico: growth hormone deficiency (GHD) or born small for gestational age (SGA); as well as to evaluate the association of adherence with growth outcomes.

Methods: ECOS is a multicenter (24 countries), 5-year, longitudinal, observational study, which aims to evaluate country-specific adherence to r-hGH therapy prescribed via the easypodTM electromechanical auto-injector. Herein we present the subanalysis for the Mexican population included in ECOS (NCT01555528). The primary endpoint was the recorded adherence at yearly intervals. Secondary endpoints were height velocity, height velocity standard deviation scores (SDS), height, height SDS, as well as IGF-1 concentrations after each year of treatment. Demographic, auxological and diagnostic data were obtained from medical notes, with adherence data obtained directly from the patients’ easypodTM records. Adherence was calculated as the number of days with injections received divided by the number of days with injections planned and expressed as percentage. Correlations between adherence and growth outcomes were calculated using Spearman’s product-moment correlation.

Results: This study included 193 Mexican patients, among whom 147 were easypodTM-naïve (mean age: 9.96±3.41 years, 56.8% boys, mean height at baseline: 124.88±18.95): 118 with GHD, 24 SGA and 5 with Turner syndrome. A total of 105 (71.4%) patients were also GH-naïve. Overall median adherence was >90% over the first year of treatment and >80% over 4 years. Adherence was not different by r-hGH indication or between GH-naïve or experienced patients. At 1-year follow-up, mean change in height was 8.78±2.20 cm, whereas mean height velocity was 8.80±1.94 cm per year. In all, 84.7% patients had normal IGF-1 concentrations at 1-year follow-up. Adherence associated with change in height (r=0.254, P=0.003), change in height SDS (r=0.239, P=0.005), height velocity (r=0.183, P=0.03) and height velocity SDS (r=0.194, P=0.03).

Conclusion: Adherence rates with the easypodTM device are high and maintained over time in GHD and SGA easypodTM-naïve Mexican patients. This system could assist physicians in practical monitoring of adherence to r-hGH treatment.