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.

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.