Once-Weekly Lonapegsomatropin Was Efficacious and Well Tolerated in Chinese Children with Growth Hormone Deficiency:

Yanqin Ying1, Haiyan Wei2, Yan Zhong3

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

PubMed

Insights

Weekly lonapegsomatropin showed superior efficacy compared to daily somatropin in treating Chinese children with growth hormone deficiency (GHD). Both treatments were found to be safe and well-tolerated, offering a new therapeutic option.

Area of Science:

  • Pediatric Endocrinology
  • Pharmacology
  • Clinical Trials

Background:

  • Lonapegsomatropin is an approved once-weekly treatment for pediatric growth hormone deficiency (GHD).
  • This study is the first to compare weekly lonapegsomatropin with daily somatropin in treatment-naive Chinese children with GHD.

Purpose of the Study:

  • To assess the efficacy and safety of weekly lonapegsomatropin versus daily somatropin in Chinese children with GHD.
  • To evaluate lonapegsomatropin's non-inferiority and superiority in improving growth parameters.

Main Methods:

  • A 52-week, randomized, open-label, active-controlled Phase 3 trial (briGHt trial) in China.
  • 153 treatment-naive, prepubertal children with GHD were randomized to weekly lonapegsomatropin or daily somatropin.
  • Primary endpoint: annualized height velocity (AHV) at week 52; Secondary endpoints: change in height SDS, IGF-1, and safety.

Main Results:

  • Weekly lonapegsomatropin demonstrated non-inferiority and superiority over daily somatropin, with a significantly higher AHV (10.66 cm/year vs. 9.75 cm/year, p=0.0010).
  • Lonapegsomatropin also showed a greater improvement in height SDS from week 13 onwards (p < 0.05).
  • Safety profiles were comparable between the two treatment groups.

Conclusions:

  • Weekly lonapegsomatropin is non-inferior and superior in efficacy to daily somatropin for treating naive Chinese children with GHD.
  • Lonapegsomatropin offers a comparable safety and tolerability profile to daily somatropin.
  • Weekly lonapegsomatropin presents a promising alternative treatment for pediatric GHD.
Abstract

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