@article{2023-03-02,
author = {, , , , , , , , },
title = {},
year = {2023},
doi = {10.1515/jpem-2022-0359},
publisher = {NP «NEICON»},
abstract = {Objectives: Somatrogon is a long-acting recombinant human growth hormone (GH) employed as a once-weekly
treatment for children with GH deficiency (GHD). A
12-month, phase 2 study of once-weekly somatrogon vs.
once-daily GH (Genotropin®) was initiated, after which
participants could enroll into an open-label extension
(OLE) evaluating the safety and efficacy of long-term
somatrogon treatment.
Methods: There were five study periods, Periods I and II
were 6 months each while Periods III, IV, and V were
12 months each. In the main study (Periods I and II), 53
prepubertal children with GHD were randomized to onceweekly somatrogon (0.25, 0.48, or 0.66 mg/kg/week) or oncedaily Genotropin (0.034 mg/kg/day); 48 continued into the
OLE, consisting of Period III (original somatrogon dose;
Genotropin recipients randomized to one of three somatrogon doses), Period IV (somatrogon 0.66 mg/kg/week), and
Period V (prefilled somatrogon pen [0.66 mg/kg/week]).
Results: At the end of Period III, the mean ± SD annual
height velocity (HV) for 0.25, 0.48, and 0.66 mg/kg/week
somatrogon groups was 7.73 ± 1.89, 7.54 ± 1.28, and
8.81 ± 1.12 cm/year, respectively; HV was sustained during
Periods IV/V. Height SD scores (SDS) showed progressive
improvement throughout the OLE, regardless of initial cohort
assignment, approaching the normal range (−0.69 ± SD 0.87)
at the end of Period V Year 1. Mild or moderate treatmentemergent adverse events were reported in 81.3% of participants, most unrelated to study drug.
Conclusions: Up to 5 years of once-weekly somatrogon was
well tolerated and resulted in sustained improvement in
height SDS and delta height SDS in prepubertal short children with GHD. Clinicaltrials.gov:NCT01592500.},
URL = {https://repo.bashgmu.ru/publication/4214},
eprint = {https://repo.bashgmu.ru/files/4390},
}