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Comparative Analysis of Human Growth Hormone in Serum Using SPRi, Nano-SPRi and ELISA Assays
Published on: January 7, 2016
Recombinant human growth hormone for children born small for gestational age: meta-analysis confirms the consistent
R Crabbé1, M von Holtey, P Engrand
1Debiopharm SA, Lausanne, Switzerland.
Insights
Higher doses of recombinant human growth hormone (r-hGH) improve growth in short children born small for gestational age (SGA). Treatment with Serono
Area of Science:
- Pediatric Endocrinology
- Growth Hormone Therapy
- Biopharmaceuticals
Background:
- Optimal recombinant human growth hormone (r-hGH) dosing for short children born small for gestational age (SGA) remains under investigation.
- Children born SGA often experience growth deficits requiring therapeutic intervention.
Purpose of the Study:
- To determine the dose-response relationship of r-hGH in short children born SGA.
- To evaluate the efficacy of a specific r-hGH formulation (Serono) at a standard dose.
Main Methods:
- Meta-analysis of clinical trials involving r-hGH treatment in SGA children.
- Development of a mathematical model to describe the dose-response relationship.
- Estimation and comparison of growth response (height-SDS gain) to different r-hGH doses and formulations.
Main Results:
- A clear dose-response relationship was established, with higher r-hGH doses yielding greater height-SDS gain.
- The higher dose (0.067 mg/kg/day) showed a mean difference of 0.48 SDS gain compared to the lower dose (0.033 mg/kg/day).
- The Serono r-hGH formulation at 0.033 mg/kg/day demonstrated an estimated height-SDS gain of 1.2, consistent with other formulations.
Conclusions:
- A significant dose-response relationship exists for r-hGH in treating short SGA children.
- Treatment with Serono r-hGH formulation at 0.033 mg/kg/day is expected to yield a meaningful therapeutic outcome.
Background:
The optimal treatment regimen of recombinant human GH (r-hGH) for short children born small for gestational age (SGA) is still under discussion.
Methods:
A meta-analysis was performed of existing clinical trials that investigated the treatment of r-hGH in short children diagnosed SGA or with intrauterine growth retardation to determine the relationship between the daily r-hGH dose (placebo/no treatment; 0.033 mg/kg/day; 0.067 mg/kg/day) and the effect on growth [change in height-SD score (SDS) for chronological age]. A mathematical model describing the dose-response relationship was produced, and growth response (gain in height-SDS) to 2 yr of r-hGH 0.033 mg/kg/day [somatropin (rDNA origin) for injection; Serono] was estimated and compared with the response to other r-hGH formulations.
Results:
The relationship between r-hGH dose and 2-yr growth response was described by an equation. The equation yielded a mean difference in height- SDS gain of 0.48 (0.35) between r-hGH 0.033 and 0.067 mg/kg/day in favor of the higher dose. The height-SDS gain after 2 yr of Serono r-hGH formulation, 0.033 mg/kg/day was estimated as 1.2. Comparison of this estimate to the growth response to 2-yr treatment at 0.033 mg/kg/day of other r-hGH formulations (mean difference in height-SDS 0.05, lower limit of the 95% confidence interval=-0.15) confirmed that growth response to Serono r-hGH formulation 0.033 mg/kg/day is an inferred response estimated to be within the range of observed responses to a (non-Serono formulation) r-hGH dose of 0.033 mg/kg/day.
Conclusion:
There is a clear dose-response relationship for r-hGH in the treatment of short children born SGA and the analysis confirmed that treatment with Serono r-hGH formulation 0.033 mg/kg/day should provide a meaningful therapeutic response.
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