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United Kingdom multicentre clinical trial of somatrem

R D Milner1, N D Barnes, J M Buckler

  • 1Children's Hospital, Sheffield.

Archives of Disease in Childhood
|August 1, 1987
PubMed

Insights

Biosynthetic methionyl growth hormone (somatrem) effectively treated growth hormone deficiency in children. This safe alternative to pituitary growth hormone showed significant height increases in most patients over one year.

Area of Science:

  • Pediatric Endocrinology
  • Biotechnology
  • Clinical Trials

Background:

  • Growth hormone deficiency (GHD) in children requires effective treatment to ensure proper growth.
  • Traditional pituitary-derived growth hormone has limitations, necessitating alternatives.
  • Biosynthetic growth hormone offers a potential solution for GHD management.

Purpose of the Study:

  • To evaluate the efficacy and safety of biosynthetic methionyl growth hormone (somatrem) in children with previously untreated GHD.
  • To assess the treatment's impact on growth velocity and identify predictive factors for response.
  • To investigate the development of antibodies and their influence on treatment outcomes.

Main Methods:

  • A multicentre clinical trial involving 54 children (aged 4.0–17.3 years) with GHD.
  • Treatment with somatrem (4 units thrice weekly) via subcutaneous or intramuscular injection for one year.
  • Height measurements every three months, with pretreatment growth rates analyzed.

Main Results:

  • Forty-two out of 54 patients (77.8%) responded to somatrem treatment, showing growth >1.5 cm/year.
  • Patients with slower pretreatment growth (<5 cm/year) showed a slightly improved prediction of response.
  • Antibody development against somatrem and E. coli protein occurred in two-thirds of patients but did not affect treatment efficacy.

Conclusions:

  • Somatrem is a safe and effective treatment for children with previously untreated growth hormone deficiency.
  • The study supports somatrem as a viable alternative to pituitary-derived growth hormone.
  • Further analysis of pretreatment growth rates could refine patient selection for somatrem therapy.

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