Real-world Data From Electronic Monitoring Of Adherence To Gh Treatment In Children With Growth Disorders:a Descriptive Analysis
Presentation Number: SUN-223
Date of Presentation: March 18, 2018, 2018
Jorge Cancela, MBA, PhD1, Sandra Guedes, Pharma.D, MSc2, Ekaterina Koledova, MD, PHD2.
1Merck KGaA, Coinsins, Switzerland, 2Merck KGaA, Darmstadt, Germany.
Poor adherence to long-term treatment with growth hormone (GH) is known to affect final growth and other clinical outcomes. Adherence has always been difficult to monitor and is usually assessed by patient testimony or prescription records. The easypod™ electromechanical injection device is unique in electronically recording/transmitting accurate, objective records of the date, time and dose injected for patients receiving GH to treat growth disorders. The device works with the easypod™ Connect platform, to allow healthcare professionals to access these data and assess adherence.
The aim of this analysis was to evaluate real-world adherence to GH therapy in different patient groups, administered via easypod™ at different time points (1, 3, 6, 12, 24, 36 and 48 months) and categorised as high (≥85%), intermediate (>56%–84%) or low adherence (≤56%).
Materials and methods:
The records of 9314 patients prescribed Saizen™ GH using the easypod™ autoinjector and transmitting their data to the eHealth platform easypod™ Connect in 33 countries were analysed. Only data after the 10th injection registered on easypod™ were analysed, to exclude test/training injections. Adherence was calculated as mg of GH injected vs mg prescribed (dosage and frequency as per easypod™ settings defined by the healthcare team). Adherence according to age and gender was assessed at seven points up to Month 48, according to the duration of each patient’s treatment within the study. Puberty cut-off points were 10 years for girls and 12 years for boys.
Overall, 9314 patients recorded >10 injections: 6728 (72.2%), 1977 (21.2%) and 609 (6.5%) were in the high, medium and low-adherence categories, respectively, at Month 1. Among the 665 patients with data up to Month 48, these values were 452 (67.9%), 150 (22.6%) and 63 (9.5%). Analysis of distribution of patients in the different adherence categories by gender at different points in time showed a different pattern (p<0.001) with a slightly greater proportion of girls with high adherence. Analysis of distribution of patients in the different adherence categories by age group and gender also revealed different patterns (p<0.05) showing that younger children were more adherent than older ones. The same pattern was noted for medium adherence, but not for the low adherence category, perhaps due to low patient numbers.
These data show that administration of GH via easypod™ is associated with high adherence to treatment, which is maintained well over time. Adherence is slightly better in girls than boys but in both genders there is a reduction in adherence with increasing age. More work is needed to understand the movement of patients among adherence categories over time.
J. Cancela: Employee; Self; Ares Trading SA, an affiliate of Merck KGaA. S. Guedes: Employee; Self; Merck. E. Koledova: Employee; Self; Merck.