ESPE Abstracts (2016) 86 LBP11

Long-Term Safety and Effectiveness of Growth Hormone Treatment in Pediatric Patients with Growth Hormone Deficiency: Interim Results of LG Growth Study

Sochung Chunga, Il Tae Hwangb, Young Jun Rhiec, Jae Hyun Kimd, Hyun-Wook Chaee, Jin Ho Choif, Jae-ho Yoog & Choong Ho Shinh

aDepartment of Pediatrics, Konkuk University School of Medicine, Seoul, Republic of Korea; bDepartment of Pediatrics, College of Medicine, Hallym University, Seoul, Republic of Korea; cDepartment of Pediatrics, Korea University Ansan Hospital, Gyenggi-Do, Republic of Korea; dDepartment of Pediatrics, Inje University College of Mecine, Ilsan Paik Hospital, Goyang-si, Gyeonggi-do, Republic of Korea; eDepartment of Pediatrics, Gangnam Severance Hospital, Seoul, Republic of Korea; fDepartment of Pediatrics, Asan Medical Center, Seoul, Republic of Korea; gDepartment of Pediatrics, Dong-A University Medical Center, Busan, Republic of Korea; hDepartment of Pediatrics, Seoul National University College of Medicine, Seoul, Republic of Korea

Background: Over 4 years, 1,526 patients received Eutropin® and EutropinPlus® (recombinant human growth hormone (GH), LG Life Sciences, Ltd.) while enrolled in the LG Growth Study (LGS), designed to monitor the long-term effectiveness and safety of GH. We present LGS experience for GH treatment during 4 years in growth hormone deficiency (GHD)

Objective and hypotheses: To evaluate the long-term safety and efficacy of Eutropin® and EutropinPlus® in Korean pediatric patients.

Method: A multicenter, long-term, prospective and retrospective study. The interim analysis was conducted in all patients who were enrolled from Jan 2012 to Mar 2016.

Results: Total 901 patients with GHD were analysed for safety during 4 years of GH treatment in GHD (Organic GHD: 85, Idiopathic GHD (IGHD): 813; Complete IGHD: 146, Partial IGHD: 401 patients). Chronological age was 8.15 years and Height SDS was −2.38 at baseline. Male and female were 530 and 317 patients, respectively. Adverse events (AEs) were reported in 18.0% in total and most of them were mild. The incidence of adverse drug reactions was 4.0%. Total 619 patients were analysed for effectiveness. Height Velocity (HV) was 8.90 cm/year at 12-month and ΔHeight SDS was 0.64 during the first year of treatment. Height SDS was improved from −2.46 (baseline) to – 1.15 over 4 years of GH treatment. In the sub group analysis of GHD, Organic vs. Idiopathic and Complete IGHD vs. Partial IGHD, for HV and ΔHeight SDS, respectively, there were no statistical differences between groups.

Conclusion: The growth response to GH (Eutropin® and EutropinPlus®) in GHD children remained effectively without specific safety concerns during 4 years.