Somatrogon versus somatropin in children with growth hormone deficiency: a real-world matched-cohort study.
Somatrogon and daily somatropin show similar growth outcomes in children with GHD, with no significant safety concerns reported.
Where it sits
this study against the rest of the hgh (somatropin) corpusSummary and findings
This study compared first-year growth outcomes and safety between somatrogon and daily somatropin in 30 children with growth hormone deficiency (GHD). No significant differences were found in annual height velocity or height standard deviation score gain. Both treatments showed similar safety profiles.
Abstract
<h4>Purpose</h4>Somatrogon is a once-weekly growth hormone (GH) analog approved for GH deficiency (GHD), but real-world head-to-head data are limited. Using a matched-cohort design with a protocol-defined IGF-1 sampling time, we compared first-year growth outcomes and safety of somatrogon and daily somatropin in children with GHD.<h4>Methods</h4>We conducted a retrospective matched-cohort study in 30 children with GHD (15 per group) at a single center. Groups were matched by age (±1 year), sex, and pubertal stage. Annual height velocity (AHV), height standard deviation score (SDS) gain, insulin-like growth factor 1 (IGF-1) SDS, insulin-like growth factor binding protein 3 (IGFBP-3), bone age advancement, and metabolic parameters were assessed at 12 months.<h4>Results</h4>AHV was similar in both groups (8.96±1.67 vs 8.84±1.57 cm/year; p=0.841). Height SDS gain did not differ (0.60±0.36 vs 0.53±0.33; p=0.569). IGF-1 SDS was numerically higher in the somatrogon group (+0.59 vs -0.14; p=0.132) but remained within safe limits in all patients. Bone age advancement, glucose, and insulin levels were similar between groups. No adverse events or injection-site reactions were documented during follow-up.<h4>Conclusion</h4>In this matched cohort, no significant differences in growth or safety outcomes were observed between somatrogon and somatropin at one year. Somatrogon appears to be a reasonable alternative to daily GH therapy in children with GHD.
Background
This paper addresses the comparative effectiveness of somatrogon, a once-weekly growth hormone analog, versus daily somatropin in treating children with growth hormone deficiency. Previous studies have primarily focused on controlled trials, with limited real-world data available. Understanding the differences in growth outcomes and safety profiles is essential for clinicians considering treatment options for GHD.
Methods
The study employed a retrospective matched-cohort design involving 30 children with GHD, divided into two groups of 15 matched by age, sex, and pubertal stage. The primary outcomes measured included annual height velocity, height standard deviation score gain, and insulin-like growth factor 1 levels, assessed at 12 months. Secondary outcomes included bone age advancement and metabolic parameters.
Results
The primary endpoint, annual height velocity, was 8.96±1.67 cm/year for the somatrogon group and 8.84±1.57 cm/year for the somatropin group, with a p-value of 0.841 indicating no significant difference. Height SDS gain was also similar, reported as 0.60±0.36 for somatrogon and 0.53±0.33 for somatropin, with a p-value of 0.569. IGF-1 SDS levels were numerically higher in the somatrogon group at +0.59 compared to -0.14 for somatropin, with a p-value of 0.132.
Interpretation
The findings suggest that there are no significant differences in growth outcomes or safety between somatrogon and somatropin, aligning with previous literature that indicates similar efficacy for different GH formulations. However, the effect sizes observed, while statistically non-significant, may not be clinically meaningful given the small sample size and lack of robust follow-up. The study's limitations, including its retrospective nature and single-center design, warrant caution in generalizing the results to broader populations.
Key findings
- AHV was 8.96±1.67 cm/year for somatrogon vs 8.84±1.57 cm/year for somatropin; p=0.841.
- Height SDS gain was 0.60±0.36 for somatrogon vs 0.53±0.33 for somatropin; p=0.569.
- IGF-1 SDS was +0.59 for somatrogon vs -0.14 for somatropin; p=0.132.
- No adverse events or injection-site reactions were documented during follow-up.
Limitations
- small n=30 with 15 per group
- single-center study limits generalizability
- retrospective design may introduce bias
- no long-term follow-up data reported