Clinical effects of yeast derived recombinant methionyl growth hormone in children with growth hormone deficiency during therapy of 3 years

ABSTRACT

Sine the success of human growth hormone (GH) synthesis by DNA recombinant technology, these GH products are widely used in the treatment of children with growth hormone deficiency. Recently, methionyl-GH has been produced in the yeast, Saccaromyces cerevisiae 2150, by the use of a DNA recombinant method in Korea. The purpose of this study was to investigate the clinical efficacy, side effect and immunogenicity of this GH product during therapy of 3year in 22 children with naive GH deficiency. The subjects of this study are aged 4.5~17.9 years, diagnosed by the failure of plasma GH to respond to insulin induced hypoglycemia, arginine and/or clonidine loading and height below -2 standard deviation of mean for their chronological age. Each subjcct received GH 0.45IU/kg/week, intramusculary in 3 devided dose, During treatment, vital signs, height and body weight checked before and every 3 months. Blood count urinalysis, blood chemistry, bone age and measurement of thyroid hormone were performed before, every 3months in year 1, and every 6 months in year 2 and 3. Assay of antibody against GH were performed before, year 1,2 and 3. The height velocity was significantly increased from an average baseline level of 2.9+/-1.1cm/year to 7.9+/-1.9cm/year after the first year, 6.6+/-1.1cm/year during the second year, and 5.9+/-1.2cm/year during the third year of GH treatment. The height standard deviation score for chronological age was decreased from an average baseline of 3.5+/-1.3 to 2.9 1.2 after the first year, 2.7 +/-1.1 during the second year, and 2.5+/-1.2 during the year of GH treatment. The increment in height age was significantly increased from an average baseline of 0.6+/-0.2 year to 1.3+/-0.3 year in year 1, 1.1+/-0.3 year in year 2, and 1.0+/-0.2 year in year 3. The increment in bone age was significantly increased from an average baseline of 0.6+/-0.2 year to 1.2+/-0.2 in year 1, 1.3+/-0.3 year in year , 2, and 1.1+/-0.3 year in year 3. Antibody against hGH was observed in 3 of the 22 patients(13.5%) in year 1 and 1 and in 2 of the 17 patients(17.7%) in year 3. And unwanted side effects were not observed in any of the 22 patients. These results suggest that this yeast derived recombinant methionyl growth hormone appears to be a safe very effective product for treating of children with GH deficiency.