ECEESPE2025 ePoster Presentations Growth Axis and Syndromes (132 abstracts)
Real world data for the first year of treatment with somatrogon of children and adolescents with growth hormone deficiency (GHD)
Eirini Dikaiakou 1 , Sofia Lekka 1 , Ioanna Kosteria 1 , Katerina Papadopoulou 1 , Maria Margarita Rossolatou 1 , Fani Athanasouli 1 , Ioannis Panagiotopoulos 1 , Sofia Zafiropoulou 2 , Stefanos Fakiolas 2 & Elpis-Athina Vlachopapadopoulou 1
1Children’s Hospital “P.& A. Kyriakou”, Department of Endocrinology-Growth and Development, Athens, Greece; 2Children’s Hospital “P.& A. Kyriakou”, Biochemistry Department-Hormones Laboratory, Athens, Greece
JOINT2169
Introduction: Somatrogon is a long-acting growth hormone (LAGH) that received marketing authorization by EMA on February 2022 for treatment of children older than 3 years old and adolescents with GHD. The aim is to describe the first-year treatment outcome in regards to change in height z-score, BMI z-score, IGF-1 z-score levels and HbA1c as well as to report possible adverse reactions of the patients treated with somatrogon in our department.
Methods: The study population consisted of 20 children (40% boys) with mean age 10.7 (SD 2.57) years with GHD, who were treated with Somatrogon from 1/2024 to 1/2025. Ten (50%) patients were naive to treatment with growth hormone (GH) while the other half switched from once-daily rhGH injection regimen. The dose of somatrogon was 0.66 mg/kg/week. Change in height z-score, BMI z-score, IGF-1 z-score, and HbA1c were calculated and compared using t-test. Furthermore, the adverse events during treatment were recorded as well as the tolerability, the adherence to treatment and the preferred injection schedule.
Results: Patients’ height z-score increased significantly during the first year of treatment with LAGH (Ht z-score -1.93 (0.842) to -1.44 (0.856), p 0.005). A significant increase in patients’ BMI z-score was appreciated (BMI z-score 0.041 (0.974) to 0.375 (0.967), p 0.001). There was no significant difference in IGF-1 z-score (0.341 (1.710) to 0.704 (1.28), p 0.167) in the whole group but there was a significant increase in the naive group IGF-1 z-score (-0.676 (1.48) to 0.42 (1.33) P <0.001). One patient had IGF-1 > 2SDS the 4th day after the 4th dose, so the dose was decreased. IGF-1 normalized afterwards. Furthermore, HbA1c levels were within normal range for both groups. Two girls reported moderate to severe pain at the injection site after switching from daily rhGH injection regimen and one patient experienced transient erythema at the injection site. However, none of the patients discontinued treatment or returned to daily dosing. They all reported 100 % compliance.
Conclusion: In this group of patients, treatment with somatrogon was well tolerated, proved to be efficient in accelerating growth velocity and improving height z-score. A trend of increasing BMI z-score was noticed that needs further observation. The limitation of this study is the small number of children and the short duration. They are preliminary real-world data.
Volume 110
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Endocrine Abstracts
ISSN 1470-3947 (print) | ISSN 1479-6848 (online)
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