ESPEYB20 2. Growth and Growth Factors Long-Acting Growth Hormone (LAGH) (5 abstracts)
2.8. Efficacy and safety of weekly somatrogon vs daily somatropin in children with growth hormone deficiency: A phase 3 study
Deal CL , Steelman J , Vlachopapadopoulou E , Stawerska R , Silverman LA , Phillip M , Kim HS , Ko C , Malievskiy O , Cara JF , Roland CL , Taylor CT , Valluri SR , Wajnrajch MP , Pastrak A & Miller BS
J Clin Endocrinol Metab. 2022 Jun 16;107(7):e2717–e2728. doi: 10.1210/clinem/dgac220. PMID: 35405011; PMCID: PMC9202717
Brief summary: This 12-months randomized, controlled, phase 3 study compared the efficacy and safety of once-weekly Somatrogon 0.66 mg/kg/week with once-daily somatropin in prepubertal children with GHD. The efficacy of once-weekly Somatrogon was noninferior to once-daily somatropin, with similar safety and tolerability profiles.
Somatrogon (MOD-4023) is a long-acting rhGH recently approved by the European Medicines Agency for the treatment of children with GHD. Somatrogon contains the amino acid sequence of human GH and 3 copies of the C-terminal peptide (CTP) of human chorionic gonadotropin, which prolongs its half-life. A previous randomized dose-finding phase 2 study was conducted in children with GHD to compare the safety, tolerability, and efficacy of 3 different doses of Somatrogon (0.25, 0.48, and 0.66 mg/kg/week) administered once weekly vs rhGH administered once daily. The 0.66 mg/kg/week dose proved to have comparable efficacy and safety profile during 12-months follow-up as daily-GH (1).
In this phase 3 study, a total of 228 treatment-nai�ve prepubertal children with GHD were randomized 1:1 to receive once-weekly Somatrogon (0.66 mg/kg/week) or once-daily somatropin (0.24 mg/kg/week) for 12 months. Height velocity (HV) at month 12 was the primary endpoint, whereas secondary efficacy measures were HV at 6 months and change in height standard deviation score (SDS) at months 6 and 12.
HV at month 12 was 10.1 cm/year for Somatrogon-treated subjects and 9.8 cm/year for somatropin-treated subjects, demonstrating noninferiority of once-weekly Somatrogon vs daily somatropin. HV at month 6 and change in height SDS at months 6 and 12 were similar between the two treatment groups. Change in bone maturation at month 12 was also similar between treatment groups. The mean value for IGF-1 SDS was −1.9 at baseline and reached 0.6 SDS at 12 months in the Somatrogon group. In the somatropin group mean IGF-1 SDS was −1.7 at baseline and remained near 0 at all post-baseline visits.
A similar percentage of subjects experienced mild to moderate adverse events (AEs) in both groups (Somatrogon: 78.9%, somatropin: 79.1%). The incidence of severe AEs was 8.3% and 5.2% in the respective groups. AEs with ≥ 5% higher incidence in the Somatrogon group than in the somatropin group were injection site erythema, injection site pain, and injection site pruritus.
In conclusion, Somatrogon administered once weekly was noninferior to somatropin administered once daily for the treatment of prepubertal children with GHD, with similar safety and tolerability profiles.
Reference: 1. Zelinska N, Iotova V, Skorodok J, et al. Long-acting C-terminal peptide-modified hGH (MOD-4023): results of a safety and dose-finding study in GHD children. J Clin Endocrinol Metab. 2017;102(5):1578–1587.
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ESPE Yearbook of Paediatric Endocrinology
ISSN 1662-4009 (Online)
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