ECEESPE2025 Poster Presentations Growth Axis and Syndromes (91 abstracts)
Long-acting PEGYlated recombinant human growth hormone (jintrolong) in short children born small for gestational age: 4-year results from a multicenter, randomized, dose-response trial in china
Xiaoping Luo 1 , Ling Hou 1 , Yan Zhong 2 , Xiaobo Chen 3 , Hongwei Du 4 , Yu Yang 5 , Feihong Luo 6 , Zhuangjian Xu 7 , Wenhui Song 8 , Xuefan Gu 9 & Yanlin Chen 10
1Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology, Wuhan, China; 2Hunan Children’s Hospital, Changsha, China; 3Children’s Hospital, Capital Institute of Pediatrics, Beijing, China; 4The First Hospital of Jilin University, Changchun, China; 5Jiangxi Provincial Children’s Hospital, Nanchang, China; 6Children’s Hospital of Fudan University, Shanghai, China; 7Affiliated Hospital of Jiangnan University, Wuxi, China; 8Shanxi Children’s Hospital/Shanxi Women and Children Hospital, Taiyuan, China; 9Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China; 10Changchun GeneScience Pharmaceutical Co., Ltd., Shanghai, China
JOINT374
Objectives: The efficacy and safety of weekly PEGylated human growth hormone (PEG-rhGH) (Jintrolong) was evaluated over 4 years in children with short stature born small for gestational age (SGA).
Methods: This is a multicenter, randomized, open-label, dose-response trial, including a 52-week main phase (NCT02375620) and an ongoing safety extension phase continuing until reaching near-adult height (NAH), conducted across 9 sites in China. Ninety-six growth hormone (GH)-treatment-naïve, non-GH-deficient, prepubertal short children born SGA were randomized in a 1:1 ration to receive weekly subcutaneous administration of Jintrolong 0. 1 mg/kg/week or 0. 2 mg/kg/week for 52 weeks. Children who completed the 52-week main phase proceeded to the extension phase, while Jintrolong was administered at an initial dose of 0. 2 mg/kg/week. Dose adjustments based on annualized height velocity (AHV; cm/year) and insulin-like growth factor I (IGF-I) response, were made up to a maximum of 0. 4 mg/kg/week until achieved NAH or the patient’s voluntary discontinuation. The primary endpoint was the change of height standard deviation score (△HT SDS) from baseline to week 52 and every 52 weeks in the extension phase. Other growth-related parameters, along with safety and treatment compliance were also monitored.
Results: The mean (SD) birth weight SDS was -2. 59 (0. 782), the mean age at the start of the study was 4. 3(0. 95) yr, and the mean height SDS at baseline was -2. 658(0. 712). The Jintrolong 0. 2 mg/kg/week group demonstrated significantly greater mean HT SDS increases compared to the 0. 1 mg/kg/week group at week 52 (0. 923 vs. 0. 511, P < 0. 0001). After 3 years of Jintrolong treatment in the extension phase (a total of 4-Year treatment from baseline), 90. 9% (60/66) of patients reached heights within the normal range for healthy Chinese children (> -2 SDS), and 53. 0% (35/66) of patients’ height SDS in conformity with their target height SDS. Additionally, mean AHV remained within the normal range during the 3-year extension treatment. Incidence of adverse events (AEs) and treatment compliance were comparable between two groups during 52-week main phase. Most AEs observed during long-term treatment were mild to moderate and most known GH-related adverse reactions.
Conclusion: Our 4-year data show that long-term continuous Jintrolong PEG-rhGH treatment at an initial dose of 0. 2 mg/kg/week, up to a maximum of 0. 4 mg/kg/week in short children born SGA results in a normalization of height during childhood followed by growth along the target height SDS.
Volume 110
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Endocrine Abstracts
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