Once-weekly somatrogon effective for treating pediatric growth hormone deficiency in Asian children
Once-weekly somatrogon is an effective and safe alternative to once-daily somatropin for treating pediatric growth hormone deficiency, with similar efficacy and safety profiles observed in the overall study population and a specific subgroup of Asian children, according to a study.
In this Phase 3 clinical trial, prepubertal patients were randomized in a 1:1 ratio to receive either once-weekly somatrogon (0.66 mg/kg/week) or once-daily somatropin (0.24 mg/kg/week) over 12 months. The primary endpoint measured was the height velocity (HV) at the 12-month mark, with secondary endpoints including HV at month 6 and changes in height standard deviation score (SDS) and insulin-like growth factor 1 (IGF-1) SDS at both 6 and 12 months.
The subgroup analysis, which focused on Asian children, involved 24 participants in the somatrogon group (mean age 7.76 years) and 21 in the somatropin group (mean age 8.10 years) across 8 countries. At month 12, the mean HV for the somatrogon group was 10.95 cm/year compared to 9.58 cm/year for the somatropin group, showing a treatment difference of 1.38 cm/year in favor of somatrogon. The 2-sided 95% confidence interval lower bound for the treatment difference was -0.20, aligning closely with the overall study population result of -0.24. At month 6, the somatrogon group also showed higher HV (11.23 cm/year) than the somatropin group (8.31 cm/year). Similar trends were observed in height SDS and IGF-1 SDS at 6 and 12 months.
The safety and tolerability profiles were comparable between the two groups, with adverse events reported in 83% of children treated with somatrogon and 76% of those treated with somatropin.
The authors concluded that once-weekly somatrogon is non-inferior to once-daily somatropin in treating pediatric GHD, offering an effective and convenient alternative. The efficacy and safety of somatrogon in Asian children were consistent with the overall study population.
Reference
Gomez R, Khadilkar V, Shembalkar J, et al. Post hoc subgroup analysis of Asian children with paediatric GHD from the global phase 3 efficacy and safety study of once-weekly somatrogon vs. once-daily somatropin. J Pediatr Endocrinol Metab. 2024;37(6):525-531. doi: 10.1515/jpem-2023-0512. PMID: 38717038.
