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Clinical trial with authentic recombinant somatropin in Sweden and Finland
Insights
Recombinant somatropin significantly boosts growth rates in children with human growth hormone (hGH) deficiency. This effective treatment shows promise for improving growth outcomes in pediatric patients.
Area of Science:
- Pediatric Endocrinology
- Growth Hormone Therapy
- Biotechnology
Background:
- Human growth hormone (hGH) deficiency impacts prepubertal children's growth.
- Previous treatments with pituitary-derived hGH had limitations.
- Recombinant somatropin offers a synthetic alternative for hGH therapy.
Purpose of the Study:
- To evaluate the efficacy and safety of recombinant somatropin in prepubertal children with hGH deficiency.
- To assess growth rate changes in both treatment-naïve and previously treated patients.
- To monitor for adverse effects and antibody development during therapy.
Main Methods:
- A cohort of 47 prepubertal children with hGH deficiency received recombinant somatropin for up to 6 months.
- Growth rates were measured before and during treatment.
- Patients were categorized into treatment-naïve and previously treated groups.
- Adverse events and anti-hGH antibodies were monitored.
Main Results:
- All 47 children demonstrated a marked increase in growth rate.
- Treatment-naïve children's growth rate increased from 4.2 cm/year to 13.9 cm/year.
- Previously treated children's growth rate increased from 2.9 cm/year to 11.1 cm/year.
- One child experienced temporary local erythema; one developed low-level anti-hGH antibodies without growth impact.
Conclusions:
- Recombinant somatropin is highly effective in improving growth rates in prepubertal children with hGH deficiency.
- The therapy is well-tolerated, with minimal adverse events and antibody formation.
- This study supports recombinant somatropin as a safe and effective treatment option for pediatric growth disorders.
Abstract:
A total of 47 prepubertal children with hGH deficiency were treated for up to 6 months with recombinant somatropin. All the children markedly increased their growth rate; 21 of them were naïve (not previously treated with hGH), and increased their growth rate from 4.2 +/- 0.2 cm/year to 13.9 +/- 0.9 cm/year (calculated from growth data after 6 months' treatment, n = 11). Of the 47 children, 26 had been previously treated for 2 +/- 0.3 years (range 0.3-8.3 years) with pituitary hGH. After a period of 0.9 +/- 0.03 years (range 5-15 months) without any hGH therapy, their growth rate increased from 2.9 cm/year to 11.1 cm/year on recombinant somatropin therapy (calculated from growth data after 6 months' treatment, n = 10). One child reacted with temporary local erythema at the injection site. Anti-hGH antibodies, with a binding capacity of 0.02 mg/litre, were detected in 1 of the 16 children after 6 months of therapy. No adverse effect on her growth rate was seen. No changes in levels of antibodies to Escherichia coli proteins were detected. No other allergic manifestations or systemic side-effects were demonstrable.