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Safety and Effectiveness of a Biosimilar Somatropin (Cinnatropin®) in Children and Adolescents Receiving Growth Hormone Therapy Over 1 Year: A Registry-Based Phase Iv Study Publisher



Rabbani A1 ; Razzaghyazar M2, 3 ; Karamizadeh Z4 ; Hashemipour M5 ; Vakili R6 ; Setoodeh A7 ; Alaei M8 ; Ghergherehchi R9 ; Salehpour S10 ; Aminzadeh M11 ; Talea A12 ; Zaeri H2 ; Ghasemi M13 ; Saki F14 Show All Authors
Authors
  1. Rabbani A1
  2. Razzaghyazar M2, 3
  3. Karamizadeh Z4
  4. Hashemipour M5
  5. Vakili R6
  6. Setoodeh A7
  7. Alaei M8
  8. Ghergherehchi R9
  9. Salehpour S10
  10. Aminzadeh M11
  11. Talea A12
  12. Zaeri H2
  13. Ghasemi M13
  14. Saki F14
  15. Sabzvari A15
  16. Kafi H16
Show Affiliations
Authors Affiliations
  1. 1. Department of Pediatrics, School of Medicine, Growth and Development Research Center, Children’s Medical Center, Tehran University of Medical Sciences, Tehran, Iran
  2. 2. Hazrat Aliasghar Children’s Hospital, Iran University of Medical Sciences, Tehran, Iran
  3. 3. Metabolic Disorders Research Center, Endocrinology and Metabolism Molecular-Cellular Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran
  4. 4. Pediatric Department, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran
  5. 5. Metabolic Liver Disease Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
  6. 6. Mashhad University of Medical Sciences, Mashhad, Iran
  7. 7. Children’s Medical Center, Tehran University of Medical Sciences, Tehran, Iran
  8. 8. Mofid Children’s Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran
  9. 9. Tabriz University of Medical Sciences, Tabriz, Iran
  10. 10. Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran
  11. 11. Pediatric Department, School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
  12. 12. Metabolic Disorders Research Center, Molecular-Cellular Endocrinology and Metabolism Research Institute, Tehran University of Medical Sciences, Tehran, Iran
  13. 13. Department of Pediatrics, School of Medicine, Dr. Kermanshahi Hospital, Kermanshah University of Medical Sciences, Kermanshah, Iran
  14. 14. Endocrinology and Metabolism Research Center, Shiraz University of Medical Sciences, Shiraz, Iran
  15. 15. CinnaGen Medical Biotechnology Research Center, Alborz University of Medical Sciences, Karaj, Iran
  16. 16. Medical Department, Orchid Pharmed Company, Tehran, Iran

Source: European Journal of Pediatrics Published:2025


Abstract

Growth hormone therapy has been shown to be effective in treating a variety of growth-related disorders. This post-marketing study assessed the effectiveness and safety of Cinnatropin®, a biosimilar growth hormone product. The data from the Orchid-Life Registry, which collects long-term effectiveness and safety data from patients receiving Cinnatropin®, was analyzed. A total of 20,465 patients were enrolled in this study, including 405 subjects in the longitudinal analysis. The most common diagnosis was growth hormone deficiency. The mean (SD) height standard deviation score (HSDS) increased from − 1.71 (1.31) to − 1.32 (1.26) in the cross-sectional population and from − 1.84 (1.18) to − 1.49 (1.13) in the longitudinal population over a period of 12 months. The baseline age exhibited an inverse correlation with changes in HSDS, suggesting that older individuals had smaller increments. Over 80% of prepubertal patients reached targeted height velocity after 1 year of treatment. The majority of adverse events were categorized as non-serious, designated as grade one in severity (mild). The most frequently observed adverse events were injection site reaction and headache. Conclusion: The study indicates that Cinnatropin® treatment results in height improvement over 1 year with an acceptable safety profile.
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