Switching to Weekly Lonapegsomatropin from Daily Somatropin in Children with Growth Hormone Deficiency: The fliGHt Trial

Aristides K. Maniatis, Ulhas Nadgir, Paul Saenger, Kent L. Reifschneider, Jennifer Abuzzahab, Larry Deeb, Larry A. Fox, Katie A. Woods, Wenjie Song, Meng Mao, Steven D. Chessler, Allison S. Komirenko, Aimee D. Shu, Samuel J. Casella, Paul S. Thornton

Research output: Contribution to journalArticlepeer-review

2 Scopus citations

Abstract

Introduction: The phase 3 fliGHt Trial evaluated the safety and tolerability of once-weekly lonapegsomatropin, a long-acting prodrug, in children with growth hormone deficiency (GHD) who switched from daily somatropin therapy to lonapegsomatropin. Methods: This multicenter, open-label, 26-week phase 3 trial took place at 28 sites across 4 countries (Australia, Canada, New Zealand, and the USA). The trial enrolled 146 children with GHD, 143 of which were previously treated with daily somatropin. All subjects received once-weekly lonapegsomatropin 0.24 mg human growth hormone/kg/week. The primary outcome measure was safety and tolerability of lonapegsomatropin over 26 weeks. Secondary outcome measures assessed annualized height velocity (AHV), height standard deviation score (SDS), and IGF-1 SDS at 26 weeks. Results: Subjects had a mean prior daily somatropin dose of 0.29 mg/kg/week. Treatment-emergent adverse events (AEs) reported were similar to the published AE profile of daily somatropin therapies. After switching to lonapegsomatropin, the least-squares mean (LSM) AHV was 8.7 cm/year (95% CI: 8.2, 9.2) at Week 26 and LSM height SDS changed from baseline to Week 26 of +0.25 (95% CI: 0.21, 0.29). Among switch subjects, the LSM for average IGF-1 SDS was sustained at Weeks 13 and 26, representing an approximate 0.7 increase from baseline (prior to switching from daily somatropin therapy). Patient-reported outcomes indicated a preference for weekly lonapegsomatropin among both children and their parents. Conclusions: Lonapegsomatropin treatment outcomes were as expected across a range of ages and treatment experiences. Switching to lonapegsomatropin resulted in a similar AE profile to daily somatropin therapy.

Original languageEnglish (US)
Pages (from-to)233-243
Number of pages11
JournalHormone Research in Paediatrics
Volume95
Issue number3
DOIs
StatePublished - Aug 1 2022

Keywords

  • Growth hormone
  • Growth hormone deficiency
  • Growth hormone replacement therapy
  • Lonapegsomatropin
  • Long-acting growth hormone
  • TransCon human growth hormone

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

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