Efficacy and Safety of Once-Weekly Somatrogon Compared with Once-Daily Somatropin (Genotropin®) in Japanese Children with Pediatric Growth Hormone Deficiency: Results from a Randomized Phase 3 Study
| Autor: | Reiko Horikawa, Toshiaki Tanaka, Yukihiro Hasegawa, Tohru Yorifuji, David Ng, Ron G. Rosenfeld, Yuko Hoshino, Akifumi Okayama, Daisuke Shima, Roy Gomez, Aleksandra Pastrak, Orlando Castellanos |
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| Rok vydání: | 2022 |
| Předmět: | |
| Zdroj: | Hormone Research in Paediatrics. 95:275-285 |
| ISSN: | 1663-2826 1663-2818 |
| DOI: | 10.1159/000524600 |
| Popis: | Introduction: Somatrogon is a long-acting recombinant human growth hormone being developed as a once-weekly treatment for children with growth hormone deficiency (GHD). The objective of this phase 3 study (NCT03874013) was to compare the efficacy and safety of once-weekly somatrogon with once-daily Genotropin in Japanese children with GHD. Methods: In this open-label, randomized, active-controlled study, 44 prepubertal Japanese children with GHD (boys: 3 to Results: Baseline characteristics were similar between treatment groups. Compared with Genotropin-treated subjects, somatrogon-treated subjects had higher least-squares mean HV at 12 months (9.65 cm/year vs. 7.87 cm/year). Once-weekly somatrogon was concluded as being comparable to once-daily Genotropin as the mean treatment difference (somatrogon-Genotropin) in HV was +1.79 cm/year (95% confidence interval, 0.97–2.61), which was greater than the preestablished margin (−1.8 cm/year). For both treatment groups, most adverse events were mild to moderate in severity and a similar proportion of subjects reported injection-site pain, although the somatrogon group reported more painful injections. Conclusion: In prepubertal Japanese children with GHD, once-weekly somatrogon was comparable to once-daily Genotropin in terms of annualized (12-month) HV. Both treatments had similar safety and tolerability profiles. |
| Databáze: | OpenAIRE |
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