hrp0095p1-119 | Growth and Syndromes | ESPE2022

Post-hoc subgroup analysis of Asian subjects from the pivotal phase 3 study of once-weekly somatrogon vs once-daily Genotropin

Gomez Roy , Khadilkar Vaman , Shembalkar Jayashri , Chu Der-Ming , Woo Ko Cheol , Wajnrajch Michael , Wang Ronnie

Objectives: Somatrogon is a long-acting recombinant human growth hormone (GH) approved by the EMA as a once weekly treatment for children with pediatric GH deficiency (GHD). A global phase 3 study compared the efficacy and safety of once-weekly somatrogon with once-daily Genotropin in pediatric subjects with GHD. The objective of this subgroup analysis was to evaluate the efficacy and safety of once-weekly somatrogon vs once-daily Genotropin in the subset of A...

hrp0082lbp-d3-1005 | (1) | ESPE2014

A 2-Year Multi-Centre, Open Label, Randomized Two Arm Study of Genotropin Treatment in Very Young Children Born Small for Gestational Age: Early Growth and Neurodevelopment

De Schepper Jean , Vanderfaeillie Johan , Mullis Primus-E , Rooman Raoul , Matthews Lisa , Dilleen Maria , Browning Richard , Gomez Roy , Wollmann Hartmut

Background: There are limited data available on the efficacy and safety of GH treatment in very young (<30 months) short children, born small for gestational age (SGA).Objectives: To determine the effect of 24 months of GH treatment on body height, BMI, and head growth as well as overall psychomotor development (using the Bayley Scale of Infant Development (BSID-II)) and demonstrate its safety in young (aged between 19 and 29 months) short SGA childr...

hrp0094p1-135 | Growth Hormone and IGFs A | ESPE2021

Long-term safety of growth hormone in adults and adolescents with growth hormone deficiency: An overview of the full-cohort in KIMS

Johannsson Gudmundur , Touraine Philippe , Feldt-Rasmussen Ulla , Pico Antonio , Vila Greisa , Carlsson Martin , Beek Andre P van , Wajnrajch Michael P , Gomez Roy , Yuen Kevin CY ,

Objective: KIMS (Pfizer International Metabolic Survey) was a postmarketing surveillance study of growth hormone (GH) replacement in adults and adolescents with GH deficiency (GHD) that concluded in October 2012. This analysis aimed to evaluate the overall safety outcomes from the full cohort of GH-treated patients of KIMS.Methods: Data were collected on adults and adolescents with confirmed GHD and closed epiphyses trea...

hrp0094p1-138 | Growth Hormone and IGFs A | ESPE2021

Safety and effectiveness of pediatric growth hormone therapy: Results from the full cohort in KIGS

Maghnie Mohamad , Ranke Michael B , Geffner Mitchell E , Vlachopapadopoulou Elpis , Dorr Helmuth G , Wikland Kerstin Albertsson , Ibanez Lourdes , Carlsson Martin , Cutfield Wayne , Rooman Raoul , Gomez Roy , Wajnrajch Michael P , Linglart Agnes , Stawerska Renata , Polak Michel , Grimberg Adda ,

Objective: KIGS (Pfizer International Growth Survey) was a large, international database of pediatric patients who received recombinant human growth hormone (rhGH) as prescribed in real-world clinical settings. This analysis evaluated the long-term safety and efficacy data from all participants until KIGS close in 2012.Methods: Children with growth disorders and treated with rhGH (Genotropin® [somatropin]...