NEW YORK (Reuters Health) – For replacement of endogenous growth hormone (GH) in children with growth-hormone deficiency (GHD), a once-weekly injection of the human GH analog somapacitan was safe and effective over three years in a phase-2 randomized controlled trial.
“Somapacitan may provide an alternative to daily GH treatment in children with GHD, with a reduced treatment burden as a result of fewer injections than daily GH (reduction from 365 to 52 injections per year),” the researchers write in the Journal of Clinical Endocrinology & Metabolism.
The U.S. Food and Drug Administration (FDA) approved somapacitan from Novo Nordisk for adults with GHD in 2020.
The current results are based on 57 (of 59 randomized) children with GHD who completed three years of treatment at 29 clinical centers in 11 countries.
During the first year, they received somapacitan (0.04, 0.08 or 0.16 mg/kg/week) or daily GH (0.034 mg/kg/day, equivalent to 0.238 mg/kg/week) by subcutaneous injection, after which all patients on somapacitan received 0.16 mg/kg/week.
Previously reported one-year data showed that height velocity (HV) and height standard deviation scores (SDS) were statistically significantly greater with somapacitan 0.16 mg/kg/week than with daily GH.
In line with the one-year data, the estimated treatment difference in height velocity for somapacitan 0.16/0.16 mg/kg/week versus daily GH at three years was 0.8 cm/year. Change in height velocity standard deviation score (SDS) from baseline to three years was comparable between somapacitan 0.16/0.16 mg/kg/week, the pooled somapacitan groups, and daily GH.
A gradual increase in height SDS from baseline was observed for all groups. At three years, height SDS was similar for the pooled somapacitan groups and daily GH.
Up to one year, somapacitan led to dose-dependent increases in insulin-like growth factor I (IGF-I), the most accepted and widely used biomarker for GH response.
After three years of treatment, the mean increase in IGF-1 SDS from baseline was similar across the somapacitan and daily-GH groups, suggesting a similar effect of somapacitan and daily GH on IGF-I (and and insulin-like binding protein-3).
In all treatment groups, three years of GH replacement therapy led to normalization of the ratio of bone age to chronological age, report Dr. Lars Savendahl of Karolinska University Hospital, in Solna, Sweden, and colleagues.
Overall, results at three years indicate that once-weekly somapacitan has a similar efficacy and safety profile to daily GH and may provide an alternative to daily GH treatment in children with GHD, they add.
The study was funded by Novo Nordisk. Several authors have disclosed financial relationships with the company.
SOURCE: https://bit.ly/3eCfDdK Journal of Clinical Endocrinology & Metabolism, online December 29, 2021.
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