Antigenicity and efficacy of authentic sequence recombinant human growth hormone (somatropin): first-year experience in the United Kingdom.
Twenty-one children were treated for GH deficiency with authentic sequence biosynthetic human GH (somatropin), 60 micrograms/kg body weight, subcutaneously, three times weekly for 1 year or longer. The magnitude of growth response and rise in serum insulin-like growth factor I levels were similar to those expected from experience with pituitary GH and somatrem. Three patients developed serum antibodies to GH with a binding capacity greater than 0.02 mg/l, but in only one patient was the GH binding capacity greater than 1.0 mg/l and he showed no attenuation of growth response. Escherichia coli polypeptide antibodies did not rise significantly and no clinically important side-effects occurred. Somatropin is safe, effective and of low immunogenicity in the treatment of GH deficiency.
Buzi
F
F
Department of Growth, Institute of Child Health, London, UK.
Buchanan
C R
CR
Morrell
D J
DJ
Preece
M A
MA
D000293:Adolescent; D000906:Antibodies / Q000378:metabolism*; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic; D005260:Female; D006128:Growth / Q000187:drug effects; D013006:Growth Hormone / Q000009:adverse effects / Q000172:deficiency / Q000276:immunology / Q000627:therapeutic use*; D006801:Humans; D007334:Insulin-Like Growth Factor I / Q000378:metabolism; D008297:Male; D011627:Puberty / Q000097:blood; D011994:Recombinant Proteins / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use; D006113:United Kingdom
D000906:Antibodies; D011994:Recombinant Proteins; D007334:Insulin-Like Growth Factor I; D013006:Growth Hormone