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

Study Overview

This study focused on the effectiveness and safety of Cinnatropin®, a biosimilar growth hormone, in treating growth-related disorders in children and adolescents.

Key Findings

  • A total of 20,465 patients participated, with 405 in a detailed analysis.
  • The most common issue was growth hormone deficiency.
  • After 12 months, the average height standard deviation score (HSDS) improved significantly:
    • From -1.71 to -1.32 in the general group.
    • From -1.84 to -1.49 in the detailed analysis group.
  • Over 80% of younger patients achieved their height growth goals within a year.

Safety Profile

The majority of side effects were mild, including:

  • Injection site reactions
  • Headaches

Most adverse events were not serious.

Conclusions

Cinnatropin® is effective in improving height over one year and has an acceptable safety profile.

Opportunities for Clinics and Patients

Based on the trial data, clinics can:

  • Set clear goals for treatment outcomes.
  • Use AI tools tailored to enhance patient management.
  • Start with pilot projects to track results and improve care.

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