The efficacy and safety of weekly somatrogon treatment in turkish children with growth hormone deficiency: a real-world cohort study.
Weekly somatrogon treatment showed a mean height gain of 10.07 cm in children with GHD over 11 months, but caution is advised due to the small sample size and lack of long-term safety data.
Where it sits
this study against the rest of the hgh (somatropin) corpusSummary and findings
This study evaluated the efficacy and safety of weekly somatrogon treatment in 39 Turkish children aged 3-18 years with growth hormone deficiency (GHD) over a mean duration of 11.31 months. The mean annual height gain was 10.07 cm, and IGF-1 SDS increased from -0.61 to 0.75. No serious adverse events were reported.
Abstract
Background Long-acting growth hormone preparations have the potential to improve treatment compliance by reducing the frequency of injections. The aim of this study was to evaluate the efficacy and safety of weekly somatrogon treatment in patients with pediatric growth hormone deficiency (GHD) under real-world conditions. Methods Patients with GHD aged 3-18 years who had been receiving somatrogon therapy for at least 6 months were included in the study. Anthropometric measurements, insulin-like growth factor-1 (IGF-1), bone age/chronological age (BA/CA) ratio, and drug-related adverse events were evaluated at baseline and at the final follow-up. Results A total of 39 patients with a mean age of 12.90 ± 1.63 years were included. The mean treatment duration was 11.31 ± 2.72 months (min-max: 6.36-16.92). The mean annual height gain was 10.07 ± 0.61 cm, and the Δ height SDS was 0.64. No significant change was observed in the BA/CA ratio (p = 0.2). The mean baseline IGF-1 SDS was - 0.61 ± 1.15, increasing to 0.75 ± 1.26 at the final follow-up (p < 0.01). In 5 of 39 patients (12.8%), IGF-1 SDS exceeded + 2 SDS, requiring dose reduction. No serious adverse events were observed. Conclusion Based on our real-world data, weekly somatrogon therapy provided an effective growth response and was well tolerated in pediatric patients with GHD. In most cases, mean IGF-1 levels remained within the normal range. However, IGF-1 levels may be elevated, particularly in pubertal patients. These findings support somatrogon as a safe and effective early treatment option in routine clinical practice, although larger and longer-term studies are required to confirm long-term safety.
Background
The paper addresses the clinical question of the efficacy and safety of somatrogon, a growth hormone therapy, in children with growth hormone deficiency. Prior studies have indicated various outcomes associated with growth hormone treatments, but this study focuses on a real-world cohort, which may provide insights into practical applications and outcomes outside of controlled clinical trials.
Methods
Not reported in abstract.
Results
Not reported in abstract.
Interpretation
Not reported in abstract.
Key findings
- Not reported in abstract.
Limitations
- Not reported in abstract.