1.Somatrogon in pediatric growth hormone deficiency: a comprehensive review of clinical trials and real-world considerations
Aristides K. MANIATIS ; Michael P. WAJNRAJCH ; Marc THOMAS ; Sung Beom CHUNG ; Jieun LEE
Annals of Pediatric Endocrinology & Metabolism 2025;30(1):11-16
Growth hormone (GH) is crucial for childhood growth and body composition. In pediatric GH deficiency (pGHD), the pituitary gland fails to produce sufficient GH, which affects linear growth in childhood. pGHD is conventionally treated with daily recombinant human GH (rhGH); however, because GH therapy lasts throughout childhood, adherence to daily rhGH treatment can be low, resulting in suboptimal effectiveness. Somatrogon is a long-acting GH analog designed to address the challenges associated with daily GH therapy for pGHD. Somatrogon administered once per week is a potential alternative to daily GH therapy. The use of somatrogon is supported by phase II and III clinical trials demonstrating that once-weekly injections are noninferior to once-daily somatropin injections in terms of efficacy, safety, and tolerability and have the advantage of reduced treatment burden. This review summarizes the clinical trials of somatrogon and discusses the therapeutic profile and effects of treating pGHD with reduced injection frequency.
2.Somatrogon in pediatric growth hormone deficiency: a comprehensive review of clinical trials and real-world considerations
Aristides K. MANIATIS ; Michael P. WAJNRAJCH ; Marc THOMAS ; Sung Beom CHUNG ; Jieun LEE
Annals of Pediatric Endocrinology & Metabolism 2025;30(1):11-16
Growth hormone (GH) is crucial for childhood growth and body composition. In pediatric GH deficiency (pGHD), the pituitary gland fails to produce sufficient GH, which affects linear growth in childhood. pGHD is conventionally treated with daily recombinant human GH (rhGH); however, because GH therapy lasts throughout childhood, adherence to daily rhGH treatment can be low, resulting in suboptimal effectiveness. Somatrogon is a long-acting GH analog designed to address the challenges associated with daily GH therapy for pGHD. Somatrogon administered once per week is a potential alternative to daily GH therapy. The use of somatrogon is supported by phase II and III clinical trials demonstrating that once-weekly injections are noninferior to once-daily somatropin injections in terms of efficacy, safety, and tolerability and have the advantage of reduced treatment burden. This review summarizes the clinical trials of somatrogon and discusses the therapeutic profile and effects of treating pGHD with reduced injection frequency.
3.Somatrogon in pediatric growth hormone deficiency: a comprehensive review of clinical trials and real-world considerations
Aristides K. MANIATIS ; Michael P. WAJNRAJCH ; Marc THOMAS ; Sung Beom CHUNG ; Jieun LEE
Annals of Pediatric Endocrinology & Metabolism 2025;30(1):11-16
Growth hormone (GH) is crucial for childhood growth and body composition. In pediatric GH deficiency (pGHD), the pituitary gland fails to produce sufficient GH, which affects linear growth in childhood. pGHD is conventionally treated with daily recombinant human GH (rhGH); however, because GH therapy lasts throughout childhood, adherence to daily rhGH treatment can be low, resulting in suboptimal effectiveness. Somatrogon is a long-acting GH analog designed to address the challenges associated with daily GH therapy for pGHD. Somatrogon administered once per week is a potential alternative to daily GH therapy. The use of somatrogon is supported by phase II and III clinical trials demonstrating that once-weekly injections are noninferior to once-daily somatropin injections in terms of efficacy, safety, and tolerability and have the advantage of reduced treatment burden. This review summarizes the clinical trials of somatrogon and discusses the therapeutic profile and effects of treating pGHD with reduced injection frequency.
4.An overview of growth hormone therapy in pediatric cases documented in the Kabi International Growth Study (Pfizer International Growth Database)
Mitchell E. GEFFNER ; Michael B. RANKE ; Michael P. WAJNRAJCH ;
Annals of Pediatric Endocrinology & Metabolism 2024;29(1):3-11
The Kabi International Growth Study (KIGS) was first established in 1987 and is the largest pharmaco-epidemiological study of recombinant human growth hormone (rhGH). KIGS is aimed at evaluating long-term safety and treatment outcomes in pediatric subjects who received Genotropin rhGH therapy (Pfizer, New York, NY, USA) as prescribed by physicians in real-world clinical practice settings. KIGS data have been used to answer multiple research questions related to growth, growth prediction, and growth hormone treatment, leading to the publication of 129 peer-reviewed manuscripts and 24 biannual reports, outcomes from 10 expert meetings, and 3 books. The KIGS has shown that rhGH is safe and increases both the short-term height gain and adult height in patients with GH deficiency (GHD) and multiple other non-GHD conditions associated with short stature.