Influence of long-acting growth hormone analogs on other hypothalamic-pituitary axes: a real-world study.
In children with isolated GHD, LAGH Somatrogon significantly increased IGF-I levels without affecting other hormonal axes, suggesting stability in adrenal and thyroid function.
Where it sits
this study against the rest of the hgh (somatropin) corpusSummary and findings
This study evaluated hormonal changes in children with isolated growth hormone deficiency (GHD) starting long-acting growth hormone (LAGH) Somatrogon or switching from daily rhGH. The primary outcome was the change in IGF-I levels after 3-6 months of treatment. The study found significant increases in IGF-I levels in both groups but no significant changes in other hormonal levels.
Abstract
Introduction/purpose Long‑acting growth hormone (LAGH) formulations have emerged to address poor adherence to daily recombinant human growth hormone (rhGH), offering reduced injection frequency and comparable efficacy. Though their efficacy and safety in children have been demonstrated in registrative trials and in some real-world studies, their impact on other pituitary axes remains unclear. Methods This observational prospective monocentric study explores hormonal changes in isolate growth hormone deficiency (GHD) children (n = 33) starting LAGH Somatrogon (n = 16, G1) or switching from daily rhGH to the same weekly analogue (n = 17, G2). In all study patients, baseline and post‑treatment assessments (after 3-6 months of weekly LAGH start) included IGF‑I, ACTH, cortisol, TSH, FT4 and FT3 levels. Results After LAGH initiation, IGF‑I SDS increased significantly in both groups (p < 0.001), more frequently exceeding 2 SDS in G2 (6/17 vs. 2/16 in G1). No significant changes occurred in TSH, FT3, FT4, ACTH or cortisol levels after LAGH start, nor between‑group differences. Conclusions In isolated GHD, adrenal and thyroid function remained stable after LAGH initiation, with comparable results in treatment‑naïve patients and in those already receiving daily therapy. A greater increase in IGF-I levels was observed in switchers, suggesting that a lower starting dose may be appropriate in patients previously treated with rhGH. Further studies are required to clarify the endocrine effects of long‑acting formulations in individuals with associated multiple pituitary hormone deficiencies.
Background
This paper addresses the impact of long-acting growth hormone analogs on hormonal levels in children with isolated growth hormone deficiency (GHD). Prior studies have shown efficacy and safety of these formulations, but their effects on other pituitary axes were not well understood. This study is significant as it explores these effects in a real-world setting.
Methods
This was an observational prospective monocentric study involving 33 children with isolated GHD. Participants were divided into two groups: 16 starting LAGH Somatrogon and 17 switching from daily rhGH. Assessments of IGF-I, ACTH, cortisol, TSH, FT4, and FT3 levels were conducted at baseline and after 3-6 months of treatment.
Results
After LAGH initiation, IGF-I SDS increased significantly in both groups (p<0.001). In the switch group (G2), 6 out of 17 patients exceeded 2 SDS compared to 2 out of 16 in the treatment-naïve group (G1). No significant changes were observed in TSH, FT3, FT4, ACTH, or cortisol levels.
Interpretation
The findings suggest that while IGF-I levels increased significantly, the lack of changes in other hormonal levels indicates stability in adrenal and thyroid function. This aligns with previous literature on the safety of LAGH formulations. However, the clinical significance of the observed increase in IGF-I, particularly in the context of small sample sizes and the observational nature of the study, limits broader conclusions.
Key findings
- IGF-I SDS increased significantly in both groups, p<0.001.
- 6/17 in G2 exceeded 2 SDS compared to 2/16 in G1.
- No significant changes occurred in TSH, FT3, FT4, ACTH, or cortisol levels after LAGH start.
Limitations
- small sample size n=33
- observational study design
- no long-term follow-up data
- single-center study