Weekly GHD treatment shows sustained efficacy over 3 years
Once-weekly treatment with somapacitan in children with growth hormone deficiency (GHD) showed sustained efficacy over 3 years, according to a study. All assessed height-based outcomes had similar safety and tolerability to daily growth hormone treatment.
In this multicenter, randomized, controlled, phase 2 study, 59 children with GHD were randomized to receive somapacitan at 0.04, 0.08, or 0.16 mg/kg/week or daily GH at 0.034 mg/kg/day (equivalent to 0.238 mg/kg/week) for the first year. Patients on somapacitan received 0.16 mg/kg/week in the subsequent years. Overall, 53 children completed the 3-year period.
At year 3 the estimated treatment difference in height velocity was 0.16/0.16 mg/kg/week for somapacitan versus 0.8 cm/year,
From baseline to year 3, change in height standard deviation score was comparable between somapacitan 0.16/0.16 mg/kg/week, the pooled somapacitan groups, and daily GH, with a gradual increase observed for all groups. At the end of the study, height standard deviation score was similar for the pooled somapacitan groups and daily GH group.
Sävendahl L, Battelino T, Rasmussen MH, et al. Effective GH replacement with once-weekly somapacitan vs daily GH in children with GHD: 3-year results from REAL 3. J Clin Endocrinol Metab. 2021;dgab928. doi: 10.1210/clinem/dgab928. Epub ahead of print. PMID: 34964458.