Outcomes ‘as expected’ with weekly lonapegsomatropin in children with GHD
The results of the phase 3 fliGHt Trial, which evaluated children with growth hormone deficiency (GHD) switched from daily somatropin therapy to weekly lonapegsomatropin, were as expected in patients of numerous ages and with many different treatment experiences. Adverse events were with the weekly treatment also found to be similar to daily somatropin therapy.
Of the 146 patients enrolled in this trial, 143 were previously treated with daily somatropin (mean prior daily somatropin dose of 0.29 mg/kg/week). All patients were treated with weekly lonapegsomatropin 0.24 mg hGH/kg. The primary outcome measure was the 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.
The least-squares mean (LSM) AHV was 8.7 cm/year 26 weeks after switching to lonapegsomatropin. From baseline to week 26, LSM height SDS had a change of +0.25 (95% CI: 0.21, 0.29).
The LSM for average IGF-1 SDS was sustained at Week 13 and Week 26. This was an approximate 0.7 increase from baseline, before switching from daily somatropin therapy.
Maniatis AK, Nadgir U, Saenger P, et al. Switching to Weekly Lonapegsomatropin from Daily Somatropin in Children with Growth Hormone Deficiency: The fliGHt Trial. Horm Res Paediatr. 2022;doi: 10.1159/000524003. Epub ahead of print. PMID: 35263755.