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Published on: January 7, 2016
Clinical studies with recombinant-DNA-derived methionyl human growth hormone in growth hormone deficient children
Insights
Methionyl human growth hormone (hGH) effectively treated growth hormone deficiency in children, significantly increasing growth rates. Antibody formation was observed but did not impede growth in most cases, showing therapeutic promise.
Area of Science:
- Biotechnology
- Endocrinology
- Pediatrics
Background:
- Growth hormone deficiency (GHD) impairs childhood growth.
- Recombinant DNA technology offers a method for producing human growth hormone (hGH).
- Methionyl-hGH is a synthesized form of hGH.
Purpose of the Study:
- To evaluate the efficacy and safety of methionyl-hGH in treating GHD in children.
- To compare the effects of methionyl-hGH with pituitary-derived hGH.
Main Methods:
- Thirty-six children with GHD received methionyl-hGH for up to 48 months.
- Growth rates and serum somatomedin C levels were monitored.
- Antibody formation to methionyl-hGH and other side effects were assessed.
Main Results:
- Methionyl-hGH treatment increased growth rate from 3.2 cm/yr to 10.5 cm/yr.
- Serum somatomedin C levels increased significantly after 6 months of therapy.
- Antibody formation to methionyl-hGH was higher than with pituitary hGH, but only one patient showed impaired growth due to high-titer antibodies.
Conclusions:
- Methionyl-hGH is an effective treatment for growth hormone deficiency in children.
- The therapeutic effect is comparable to pituitary hGH.
- While antibody formation can occur, it does not consistently lead to poor growth outcomes.
Abstract:
Thirty-six children with growth hormone deficiency were treated for up to 48 months with methionyl human growth hormone (hGH) synthesised by DNA recombinant methods. The growth rate for these children increased from 3.2 +/- 1.1 cm/yr to 10.5 +/- 2.2 cm/yr (mean +/- SD). This was similar to the effect of pituitary hGH in ten GH deficient children, 3.8 +/- 1.0 to 10.1 +/- 1.1 cm/yr. Serum somatomedin C rose from 0.26 +/- 0.23 U/ml to 0.79 +/- 0.53 U/ml after 6 months of methionyl-hGH therapy, similar to the effect of pituitary hGH. The incidence of antibody formation to methionyl-hGH was higher than that observed with pituitary hGH (Kabi) but poor growth was observed only in the one patient on methionyl-hGH who acquired high-titre high-binding-capacity antibodies to hGH. No consistent changes in levels of antibodies to Escherichia coli proteins were detected. No other allergic manifestations or systemic side-effects were demonstrable.
