AUTHOR=Jiang Zhouhong , Chen Xuefeng , Dong Guanping , Lou Yin , Zhang Jianping , Cheng Xinran , Pan Jiayan , Liao Wei , Wu Jinzhun , Huang Xiaodong , Jin Xianjiang , Liu Deyun , Zeng Ting , Zhu Shunye , Dong Qin , Luo Xiaoming , Lan Dan , Cao Lizhi , Zhang Xingxing , Liu Jing , Dai Mingjuan , Zhang Manyan , Liu Li , Dong Junhua , Zhao Dongmei , Ni Shaoqing , Fu Junfen 

TITLE=Short-term efficacy and safety of a lower dose of polyethylene glycol recombinant human growth hormone in children with growth hormone deficiency: A randomized, dose-comparison study

JOURNAL=Frontiers in Pharmacology

VOLUME=Volume 13 - 2022

YEAR=2022

URL=https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2022.955809

DOI=10.3389/fphar.2022.955809

ISSN=1663-9812

ABSTRACT=<p><bold>Objective:</bold> Polyethylene glycol recombinant human growth hormone (PEG-rhGH, Jintrolong<sup>®</sup>) is the first long-acting rhGH preparation that is approved to treat children with growth hormone deficiency (GHD) in China. Clinical experience with dose selections of PEG-rhGH is scarce. The present study compared the efficacy and safety of a lower dose to increase dosing regimens of PEG-rhGH treatment.</p><p><bold>Methods:</bold> A multicenter, randomized, open-label, dose-comparison clinical study was conducted to compare the improvements in the height standard deviation score (Ht SDS), height velocity (HV), insulin-like growth factor-1 (IGF-1) SDS, and safety profiles of children with GHD who are treated with 0.2 mg/kg/week of PEG-rhGH dose or 0.14 mg/kg/week for 26 weeks.</p><p><bold>Results:</bold> Ht SDS, HV, and IGF-1 SDS increased significantly after PEG-rhGH treatment in the two dose groups (<italic>p</italic> &lt; 0.05). The improvements of Ht SDS, HV, and IGF-1 SDS were more significant in the high-dose group than in the low-dose group (<italic>p</italic> &lt; 0.05). Ht SDS improvement in low-dose group was not non-inferiority to that in the high-dose group (<italic>p</italic> = 0.2987). The incidences of adverse events were comparable between the two groups.</p><p><bold>Conclusion:</bold> The improvements of Ht SDS, HV, and IGF-1 SDS were more significant in the high-dose group than in the low-dose group (<italic>p</italic> &lt; 0.05). PEG-rhGH at the dose of 0.14 mg/kg/week was effective and safe for children with GHD.</p><p><bold>Clinical Trial Registration:</bold><ext-link ext-link-type="uri" xlink:href="http://clinicaltrials.gov" xmlns:xlink="http://www.w3.org/1999/xlink">clinicaltrials.gov</ext-link>, identifier NCT02908958.</p>