INSIGHTS-GHT: first evaluation of paediatric patients with long-acting growth hormone therapy (LAGH) from the german registry

Joachim Woelfle; Christof Land; Desiree Dunstheimer; Timo Deutschbein; Erwin Lankes; Ilonka Kreitschmann-Andermahr; Strasburger Christian J.; David Pittrow; Christine Pausch; Dirk Schnabel

doi:10.1530/endoabs.110.EP819

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Endocrine Abstracts (2025) 110 EP819 | DOI: 10.1530/endoabs.110.EP819

ECEESPE2025 ePoster Presentations Growth Axis and Syndromes (132 abstracts)

INSIGHTS-GHT: first evaluation of paediatric patients with long-acting growth hormone therapy (LAGH) from the german registry

Joachim Woelfle ¹ , Christof Land ² , Desiree Dunstheimer ³ , Timo Deutschbein ⁴ , Erwin Lankes ⁵ , Ilonka Kreitschmann-Andermahr ⁶ , Christian J. Strasburger ⁷ , David Pittrow ⁸ , Christine Pausch ⁸ & Dirk Schnabel ⁵

Author affiliations

¹Friedrich-Alexander-Universität Erlangen-Nürnberg, Department of Pediatrics and Adolescent Medicine, University Hospital Erlangen, Erlangen, Germany; ²Zentrum für Kinder- und Jugendendokrinologie, Endokrinologie, Gauting, Bayern, Deutschland, Gauting, Germany; ³Universitätsklinikum, Klinik für Kinder- und Jugendmedizin, Augsburg, Bayern, Deutschland, Augsburg, Germany; ⁴Medicover Oldenburg MVZ, Oldenburg, Germany, Oldenburg, Germany; ⁵Charité, Universitätsmedizin, Pädiatrische Endokrinologie/SPZ für chronisch kranke Kinder, Berlin, Berlin, Deutschland, Berlin, Germany; ⁶Universitätsklinikum, Klinik für Neurochirurgie und Wirbelsäulenchirurgie, Essen, Nordrhein-Westfalen, Deutschland, Essen, Germany; ⁷Charité - Universitätsmedizin Berlin, Klinik für Endokrinologie und Stoffwechselmedizin, Berlin, Berlin, Deutschland, Berlin, Germany; ⁸GWT-TUD, Innovationszentrum Real-World Evidence, Dresden, Sachsen, Deutschland, Dresden, Germany

JOINT2262

Introduction: INSIGHTS-GHT is the world’s first cross-product registry study on growth hormone (GH) therapy. It includes patients of all ages across all approved indications, enabling the documentation of real-world GH treatment patterns from childhood through transition to adulthood in Germany, and the analysis of a wide range of associated relevant scientific questions. In particular, since the end of 2023, patients treated with the newly approved long-acting GH preparations (LAGH) Ngenla© (Somatrogron), Skytrofa© (Lonapegsomatropin) and Sogroya© (Somapacitan) are also documented.

Methods: Since its launch in February 2022, more than 1800 patients from 30 endocrinological institutions in Germany have been included in the INSIGHTS-GHT registry. We report on the first interim evaluation of paediatric patients with growth hormone deficiency (GHD) who are receiving therapy with a LAGH. These patients receive LAGH subcutaneously once weekly. Here we report the findings from a database interim analysis dated 10/Jan/2025.

Results: So far, 62 children and adolescents under the age of 18 with GHD under LAGH from 14 centres have been included. Of these, 76 % are male. 42 cases (70 %) suffer from idiopathic growth hormone deficiency, 18 cases (30 %) have organic growth hormone deficiency. The age at the start of LAGH therapy was 9.2 (3.7) years. The majority of patients (81%) were prepubertal at the start of LAGH therapy. 34 patients (57%) had previously received therapy with daily GH for an average of 4.3 (2.9) years (‘switch patients’). The body height at the start of LAGH therapy was -1.9 (1.2) SDS, BMI was -0.4 (1.2) SDS. The starting dose of the long-acting products was below the manufacturer’s recommendation in 82 % of cases, with a median of 92 % of the recommended dose.

Conclusion: The INSIGHTS-GHT registry provides an excellent research platform to investigate various aspects of somatropin therapy, including data on the use of the preparations and the long-term effects in terms of safety, efficacy and quality of life. Initial baseline data on paediatric patients on long-acting GH therapy provide indications of its acceptance, indicate initial dosing of LAGH slightly below doses recommended by the manufacturers and will enhance our understanding of clinical practice.

Reference: Schnabel D. et al for the INSIGHTS-GHT Study Group. Investigating significant health trends in growth hormone treatments registry: rationale, aims and design of a nationwide prospective registry (study protocol). BMC Orphanet Journal of Rare Diseases 2023;18:112. https://doi.org/10.1186/s13023-023-02716-3