Objectives: This study was performed to evaluate effectiveness on near-adult height (NAH) and safety of recombinant human growth hormone (rhGH) (Eutropin® Inj., Eutropin®Plus Inj., Eutropin®AQ Inj., LG Chem, Ltd.) treatment in children with growth hormone deficiency (GHD) and Turner syndrome (TS).
Methods: The LG Growth Study (LGS) is a multicenter, long-term, observational study designed to evaluate the long-term effectiveness and safety of rhGH treatment (NCT01604395). The data on NAH (height at ≥18 years of age, or height velocity <2 cm/year at ≥16 years for boys or ≥15 years for girls) and safety of rhGH were analyzed.
Results: This study included 51 GHD patients and 57 TS patients. At the start of treatment, the mean age of the patients with GHD and TS was 12.2±3.0 and 10.8±3.2 years, respectively. Bone age (BA) of GHD and TS was 10.5±3.1 and 9.7±2.8 years, respectively. The median initial rhGH dose was 0.2 and 0.3 mg/kg per week, respectively. The mean baseline height SDS (HtSDS) for GHD and TS patients was −2.80±1.45 and −3.51±0.84, respectively. The midparental height (MPH) SDS was −1.09±0.88 and −0.56±0.83, and a difference between baseline HtSDS and MPH SDS was −1.97±1.32 (95% CI: −2.44 to −1.51) and −2.86±0.95 (95% CI: −3.17 to −2.55), respectively. The mean age at the measurement of NAH for GHD and TS patients was 18.4±2.6 and 17.6±1.6 years, respectively. Duration of treatment was 4.9±2.7 and 5.3±2.5 years, respectively. There was no change of dose during the treatment period. The mean HtSDS for GHD and TS patients was −1.29±1.62 and −2.36±0.92 at NAH, and a difference between NAH SDS and MPH SDS were −0.22±1.03 (95% CI: −0.56 to 0.11) and −1.72±0.80 (95% CI: −1.96 to −1.49), respectively. Adverse events (AEs) were reported in 20 GHD patients (39.2%) and 28 TS patients (49.1%). The most common AEs were upper respiratory tract infection (9.3%) and headache (7.4%). Serious adverse drug reactions Craniopharyngioma was recurred in two patients with GHD (3.9%) during rhGH treatment.
Conclusions: In this study, rhGH treatment increased the HtSDS and reduced the gap between HtSDS and MPH SDS at NAH in both patients with GHD and TS.
27 - 29 Sep 2018
European Society for Paediatric Endocrinology