Long-term study deems weekly long-acting GH safe, effective in children with GHD
Treatment with weekly long-acting growth hormone (LAGH) lonapegsomatropin in children with growth hormone deficiency (GHD) was safe and well-tolerated, with no new safety signals identified, according to ongoing, phase 3, open-label extension trial. Through the 2nd year of treatment, children demonstrate a continued improvement of height SDS without excess advancement of bone age.
Patients who completed a prior Phase 3 lonapegsomatropin parent trial (heiGHt or fliGHt) were included. In treatment-naïve patients from the heiGHt trial, treatment with lonapegsomatropin during the enlighten trial was associated with continued improvements in height SDS through Week 104 (-2.89 to -1.37 for- the lonapegsomatropin group; -3.0 to -1.52 for the daily somatropin group).
Amongst patients switched from the fliGHt trial, height SDS continued to improve (-1.42 at fliGHt baseline to -0.69 at Week 78).
There was only minimal advancement of bone age relative to chronological age with continued lonapegsomatropin treatment among heiGHt trial patients after 104 weeks.
Patients in the United States switched to the TransCon hGH Auto-Injector when it became available and reported fewer local tolerability reactions compared with syringe/needle.
Maniatis AK, Casella SJ, Nadgir UM, et al. Safety and Efficacy of Lonapegsomatropin in Children with Growth Hormone Deficiency: enliGHten Trial 2-Year Results. J Clin Endocrinol Metab. 2022;dgac217. doi: 10.1210/clinem/dgac217. Epub ahead of print. PMID: 35428884.