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Polyethylene glycol recombinant human growth hormone in Chinese prepubertal slow-growing short children: doses
Jiajia Chen1, Yan Zhong2, Haiyan Wei3
1Department of Endocrine and Genetics and Metabolism, Beijing Children's Hospital, Capital Medical University, National Centre for Children's Health, No.56 Nanlishi Road, Xicheng District, 100045, Beijing, China.
Insights
Individualized-dose polyethylene glycol recombinant human growth hormone (PEG-rhGH) effectively increased height in children with short stature. Lower doses (0.10-0.14 mg/kg/week) were less effective than higher doses (0.15-0.20 mg/kg/week) in certain patient groups.
Area of Science:
- Pediatrics
- Endocrinology
- Pharmacology
Background:
- Short stature affects children's growth and development.
- Polyethylene glycol recombinant human growth hormone (PEG-rhGH) is a treatment option.
- Individualized dosing strategies are crucial for optimizing treatment efficacy.
Purpose of the Study:
- To evaluate the effectiveness of individualized-dose PEG-rhGH in children with short stature.
- To determine optimal starting dosages based on patient characteristics.
- To assess the impact of different dosages on height standard deviation score (ΔHt SDS).
Main Methods:
- A real-world study involving 510 children with short stature across 19 hospitals in China.
- Treatment with PEG-rhGH for 6 months with starting dosages ranging from 0.10 to 0.20 mg/kg/week.
- Analysis of primary outcome: change in height standard deviation score (ΔHt SDS), stratified by dosage groups and baseline IGF-1 levels.
Main Results:
- The mean 6-month ΔHt SDS for the total cohort was 0.49 ± 0.27.
- Lower dosages (0.10-0.14 mg/kg/week) showed significantly lower ΔHt SDS compared to higher dosages (0.15-0.20 mg/kg/week).
- Higher dosages were associated with better treatment effects in children with baseline IGF-1 SDS between -2 and 0, and younger children showed greater height increases.
Conclusions:
- PEG-rhGH effectively increases height in prepubertal short children.
- A starting dose of 0.10 mg/kg/week is suggested for patients with baseline IGF-1 SDS < -2.
- For other IGF-1 statuses, starting doses of 0.15-0.20 mg/kg/week may be preferred for optimal height gain.
Background:
To evaluate the effectiveness of individualized-dose polyethylene glycol recombinant human growth hormone (PEG-rhGH) for short stature.
Methods:
This real-world study enrolled children with short stature in 19 hospitals throughout China. They were treated with PEG-rhGH for 6 months. The starting dosage ranged from 0.10 to 0.20 mg/kg/week. The primary outcome was the change in height standard deviation score (ΔHt SDS).
Results:
Five hundred and ten patients were included and grouped based on dosage as A (0.10-0.14 mg/kg/week), B (0.15-0.16 mg/kg/week), C (0.17-0.19 mg/kg/week), and D (0.20 mg/kg/week). The mean 6-month ΔHt SDS for the total cohort was 0.49 ± 0.27, and the means differed among the four dose groups (P = 0.002). The ΔHt SDS was lower in group A than in groups B (LSM difference [95%CI], -0.09 [-0.17, -0.01]), C (LSM difference [95%CI], -0.10 [-0.18, -0.02]), and D (LSM difference [95%CI], -0.13 [-0.21, -0.05]) after adjusting baseline covariates. There were no significant differences among groups B, C, and D. When the baseline IGF-1 was < -2 SDS or > 0 SDS, the △Ht SDS was not different among the four groups (P = 0.931 and P = 0.400). In children with baseline IGF-1 SDS of -2 ~ 0 SDS, a higher dosage was associated with a better treatment effect (P = 0.003), and the △Ht SDS was lower in older children than in younger ones (P < 0.001).
Conclusions:
PEG-rhGH could effectively increase height in prepubertal short children. When the baseline IGF-1 was < -2 SDS, 0.10 mg/kg/week could be a starting dose. In other IGF-1 statuses, 0.15-0.20 mg/kg/week might be preferred.
Trial Registration:
ClinicalTrials.gov: NCT03249480 , retrospectively registered.
