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Long-acting PEGylated recombinant human growth hormone (Jintrolong) for children with growth hormone deficiency:

Xiaoping Luo1, Ling Hou1, Li Liang2,3

  • 1Department of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China.

European Journal of Endocrinology
|June 2, 2017
PubMed

Insights

Weekly pegylated human growth hormone (PEG-rhGH), Jintrolong, demonstrated superior efficacy and comparable safety to daily rhGH in treating children with growth hormone deficiency (GHD). This offers a more convenient treatment option for GHD.

Area of Science:

  • Endocrinology
  • Pediatric Endocrinology
  • Pharmacology

Background:

  • Growth hormone deficiency (GHD) in children necessitates effective and safe treatment options.
  • Daily recombinant human growth hormone (rhGH) injections are the current standard, posing challenges in compliance and convenience.
  • Pegylated recombinant human growth hormone (PEG-rhGH) offers a potential for less frequent administration.

Purpose of the Study:

  • To assess the efficacy and safety of a weekly PEG-rhGH formulation (Jintrolong) compared to daily rhGH in children with GHD.
  • To determine the optimal dosage of Jintrolong based on Phase II trial data.
  • To evaluate growth-related parameters, safety, and treatment compliance in a larger pediatric population.

Main Methods:

  • Conducted multicenter, open-label, randomized controlled trials (Phase II and III) involving 108 and 343 treatment-naive GHD children, respectively.
  • Patients received either weekly Jintrolong (PEG-rhGH) at 0.1 or 0.2 mg/kg/week, or daily rhGH (0.25 mg/kg/week) for 25 weeks.
  • Primary endpoint was height velocity (HV) increase; secondary endpoints included height standard deviation scores, safety, and compliance.

Main Results:

  • Phase II established preliminary efficacy, safety, and recommended dosage for Jintrolong.
  • Phase III showed significantly greater HV increases with weekly Jintrolong (0.2 mg/kg/week) compared to daily rhGH (P < 0.05).
  • Jintrolong treatment also led to significantly greater improvement in height standard deviation scores, with comparable adverse event rates and compliance.

Conclusions:

  • Weekly Jintrolong (PEG-rhGH) at 0.2 mg/kg/week for 25 weeks is an effective and safe treatment for pediatric GHD.
  • Jintrolong demonstrated non-inferiority and superior efficacy in height velocity compared to daily rhGH.
  • The weekly formulation offers a promising alternative for GHD management, potentially improving patient adherence.
Abstract

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