: Long-acting growth hormone (LAGH) preparations have moved from development to routine clinical use over the past decade. Several products are now approved for paediatric growth hormone deficiency (GHD), selected non-GHD short-stature indications, and, in some regions, for adult GHD. The Growth Hormone Research Society convened an international workshop in October 2025 to reappraise the evidence base and refine clinical recommendations. Currently, data are available for up to 7 years of LAGH treatment in over 8000 individuals. This remains substantially shorter and smaller than for daily GH. Across preparations, short- to mid-term efficacy appears comparable to daily somatropin, provided dosing is individualized and monitored appropriately. Approvals and pivotal trials include both treatment initiation and switching from daily GH, depending on product and regional label. No new major safety signals have been identified in trials and real-world reports, although data on BMI trajectories require further evaluation. Injection-site reactions remain the most frequent adverse event and vary by formulation. Anti-drug antibodies have been observed, yet evidence suggests they have limited clinical impact. Effects on glucose metabolism resemble those of daily therapy, but metabolically, high-risk groups are under-represented in studies. Among cancer survivors, data on tumour recurrence and second neoplasms with LAGH are not yet available. Recommendations and practice points emphasized careful patient selection and counselling, product-specific dosing, and insulin-like growth factor-I (IGF-I) monitoring. Urgent knowledge gaps include transition care, long-term efficacy, adherence, and safety in cancer survivors. Well-resourced registries are essential for addressing these gaps and supporting safe, effective, and patient-centred use of LAGH.

Schilbach, K., Clayton, P., Agrawal, N., Arlien-Søborg, M.c., Backeljauw, P.f., Biller, B., et al. (2026). Long-acting growth hormone: an updated Growth Hormone Research Society consensus statement. EUROPEAN JOURNAL OF ENDOCRINOLOGY, 195(3), 73-96 [10.1093/ejendo/lvag167].

Long-acting growth hormone: an updated Growth Hormone Research Society consensus statement

Cianfarani S.;
2026-01-01

Abstract

: Long-acting growth hormone (LAGH) preparations have moved from development to routine clinical use over the past decade. Several products are now approved for paediatric growth hormone deficiency (GHD), selected non-GHD short-stature indications, and, in some regions, for adult GHD. The Growth Hormone Research Society convened an international workshop in October 2025 to reappraise the evidence base and refine clinical recommendations. Currently, data are available for up to 7 years of LAGH treatment in over 8000 individuals. This remains substantially shorter and smaller than for daily GH. Across preparations, short- to mid-term efficacy appears comparable to daily somatropin, provided dosing is individualized and monitored appropriately. Approvals and pivotal trials include both treatment initiation and switching from daily GH, depending on product and regional label. No new major safety signals have been identified in trials and real-world reports, although data on BMI trajectories require further evaluation. Injection-site reactions remain the most frequent adverse event and vary by formulation. Anti-drug antibodies have been observed, yet evidence suggests they have limited clinical impact. Effects on glucose metabolism resemble those of daily therapy, but metabolically, high-risk groups are under-represented in studies. Among cancer survivors, data on tumour recurrence and second neoplasms with LAGH are not yet available. Recommendations and practice points emphasized careful patient selection and counselling, product-specific dosing, and insulin-like growth factor-I (IGF-I) monitoring. Urgent knowledge gaps include transition care, long-term efficacy, adherence, and safety in cancer survivors. Well-resourced registries are essential for addressing these gaps and supporting safe, effective, and patient-centred use of LAGH.
2026
Pubblicato
Rilevanza internazionale
Recensione
Sì, ma tipo non specificato
Settore MED/38
Settore MEDS-20/A - Pediatria generale e specialistica
English
GHD; IGF-I monitoring; LAGH; efficacy; immunogenicity; registries; safety
Schilbach, K., Clayton, P., Agrawal, N., Arlien-Søborg, M.c., Backeljauw, P.f., Biller, B., et al. (2026). Long-acting growth hormone: an updated Growth Hormone Research Society consensus statement. EUROPEAN JOURNAL OF ENDOCRINOLOGY, 195(3), 73-96 [10.1093/ejendo/lvag167].
Schilbach, K; Clayton, P; Agrawal, N; Arlien-Søborg, Mc; Backeljauw, Pf; Biller, Bmk; Boguszewski, Cl; Boguszewski, Mcs; Chanson, P; Chatelain, P; Cia...espandi
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2108/473646
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