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Biosynthetic human growth hormone in the treatment of growth hormone deficiency
J H Holcombe1, P M Conforti, A C Wong
1Lilly Research Laboratories, Indianapolis.
Insights
Biosynthetic somatropin (rhGH) treatment significantly increased height velocity in children with growth hormone deficiency (GHD). This study confirms rhGH efficacy for improving growth in prepubertal and pubertal children with GHD.
Area of Science:
- Pediatric Endocrinology
- Biotechnology
- Growth Disorders
Background:
- Growth hormone deficiency (GHD) affects numerous children worldwide.
- Effective treatment is crucial for achieving optimal growth outcomes.
- Biosynthetic somatropin (rhGH) offers a therapeutic option for GHD.
Purpose of the Study:
- To evaluate the long-term efficacy and safety of biosynthetic somatropin (rhGH) in children with GHD.
- To assess the impact of rhGH on height velocity in prepubertal and pubertal children.
- To analyze growth responses based on GHD etiology and bone age.
Main Methods:
- A total of 309 treatment-naïve children with GHD were enrolled in an ongoing trial.
- Children received rhGH at a dosage of 0.06 mg/kg three times weekly for up to 3 years.
- Height velocity and height velocity SDS were measured before and during treatment.
Main Results:
- Mean height velocity increased significantly in prepubertal children from 3.8 cm/year to 8.9 cm/year in the first year of rhGH therapy.
- Height velocities remained elevated in the second and third years of treatment.
- Children with a bone age under 5 years showed a significantly greater height velocity response in the first year compared to older children.
Conclusions:
- Biosynthetic somatropin (rhGH) is effective in increasing height velocity in children with GHD.
- The treatment demonstrates sustained efficacy over multiple years.
- Early initiation of rhGH therapy, particularly in younger children, may lead to greater growth responses.
Abstract:
A total of 309 previously untreated children with growth hormone deficiency (GHD) (219 boys, 90 girls; mean age 8.4 +/- 3.9 years, range 1.5-19 years) were treated for up to 3 years in an ongoing trial designed to examine the long-term efficacy and safety of biosynthetic somatropin (rhGH). The children were treated with rhGH, 0.06 mg/kg (0.16 IU/kg) three times weekly. In the prepubertal children, the mean height velocity increased during the first year from 3.8 +/- 1.8 cm/year to 8.9 +/- 2.2 cm/year (n = 188). During the second and third years, their height velocities were 7.1 +/- 1.1 (n = 147) and 6.3 +/- 1.2 cm/year (n = 64), respectively. The height velocity SDS increased from -2.5 +/- 1.9 before treatment to 3.1 +/- 2.6 during the first year of treatment in the prepubertal children. The mean pretreatment height velocity in those with idiopathic GHD (3.8 +/- 1.6 cm/year) did not differ from that in children with organic GHD (3.8 +/- 2.3 cm/year). In addition, the height velocities during the first year of therapy did not differ significantly with respect to the aetiology of GHD. For the children who entered puberty during the study, the mean height velocity increased from 3.0 +/- 1.7 cm/year before treatment to 8.4 +/- 2.3 cm/year during the first year of rhGH therapy. In the first year, the height velocity of children with a bone age of less than 5 years (9.4 +/- 2.3 cm/year) was significantly greater than that in children with a bone age of 5-10 years (8.4 +/- 1.8 cm/year) or greater than 10 years (7.8 +/- 2.2 cm/year: p = 0.001).(ABSTRACT TRUNCATED AT 250 WORDS)