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Published on: January 7, 2016
Corroboration of Height Velocity Prediction Markers for rhGH With an Oral GH Secretagogue Treatment in Children With
Werner F Blum1, George M Bright2, Minh-Ha T Do2
1Center of Child and Adolescent Medicine, Justus-Liebig University, Giessen, Germany.
Insights
Predicting growth hormone therapy response is crucial. Baseline insulin-like growth factor-I (IGF-I) and stimulated growth hormone (GH) levels effectively predict height velocity (HV) in children with GHD.
Area of Science:
- Pediatric Endocrinology
- Growth Hormone Therapy
- Biomarker Discovery
Background:
- Recombinant human growth hormone (rhGH) treats pediatric growth hormone deficiency (GHD), with severe GHD showing greatest response.
- Oral GH secretagogues (GHS) may benefit moderate GHD cases.
- Differentiating severe from moderate GHD is key for optimal treatment selection.
Purpose of the Study:
- To assess baseline insulin-like growth factor-I (IGF-I) and stimulated peak growth hormone (GH) as predictors of 12-month height velocity (HV) in children with GHD.
Main Methods:
- Analysis of data from 514 prepubertal children with idiopathic isolated GHD naive to rhGH treatment.
- Categorization of severe versus moderate GHD based on GH and IGF-I levels.
- Evaluation of baseline auxologic and hormone profiles and first-year rhGH treatment growth response.
Main Results:
- Severe GHD comprised 15.8% (81/514) and moderate GHD 84.2% (433/514) of the cohort.
- Significant differences observed in GHD indicators between severe and moderate groups.
- Insulin-like growth factor-I and stimulated GH were significant independent predictors of height velocity.
Conclusions:
- Peak GH from stimulation testing and baseline IGF-I are predictive markers for height velocity response to rhGH therapy.
- These markers can aid in identifying children likely to benefit most from rhGH treatment.
Context:
Recombinant human growth hormone (rhGH) is approved for treatment of pediatric growth hormone deficiency (GHD), with greatest growth responses observed in those with severe GHD. Orally administered GH secretagogues (GHS) may be useful treatment in patients with moderate GHD. Distinguishing children with severe vs moderate GHD could identify children who would be better treated with rhGH or GHS.
Objectives:
Evaluate baseline insulin-like growth factor-I (IGF-I) and stimulated peak GH response as predictors of 12-month height velocity (HV) in children with GHD.
Design:
Data on children with GHD were analyzed in a legacy data base (GeNeSIS data).
Participants:
514 naïve to rhGH-treatment, prepubertal children with idiopathic isolated GHD for whom stimulated GH, baseline serum IGF-I, and first-year HV during rhGH treatment data are available.
Outcome Measures:
Children with severe or moderate GHD were categorized based on GH and IGF-I data and evaluated based on baseline auxologic and hormone profiles and first-year growth response to rhGH.
Results:
Cohorts of severe and moderate GHD were 81/514 (15.8%) and 433/514 (84.2%). Cohorts differed significantly with regard to indicators of GHD [eg, baseline height SD score (SDS), height SDS minus target height SDS, HV, HV SDS, and change in height SDS during rhGH treatment]. Multiple regression analysis showed IGF-I and stimulated GH were significant predictors of HV independent of other known variables. Expected first-year HV in moderate GHD was 8.3 cm/y.
Conclusions:
The combination of peak GH to GH stimulation testing and baseline IGF-I concentration are predictive enrichment markers for annualized HV responses to rhGH therapy.
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