Comparison of hyaluronidase-facilitated subcutaneous immunoglobulin 10% pharmacokinetics in pediatric and adult patients with primary immunodeficiency: an analysis of three phase 3 clinical trials.
- 1Clinical Pharmacology & Early Clinical Development, Takeda Development Center Americas, Inc., Cambridge, MA, United States.
- 2Clinical Pharmacology, Certara Strategic Consulting, Certara USA, Inc., Radnor, PA, United States.
Abstract
Introduction
Facilitated subcutaneous immunoglobulin (fSCIG) 10% is approved for the treatment of primary immunodeficiency (PID) in both pediatric and adult patients. However, it remains unclear whether there is a clinically meaningful difference in the pharmacokinetics (PK) of immunoglobulin G (IgG) between these two populations.Methods
Serum total IgG concentrations in pediatric and adult patients (aged 3-80 years) with PID from three phase 3 clinical trials of fSCIG 10% were analyzed (NCT00814320, NCT01175213, NCT03277313). Serum total IgG trough concentrations (C trough) were compared against the conservative threshold for treatment effectiveness of 7 g/l, and between adult and pediatric patients (aged 2 to <17 years) and pediatric subgroups (2 to <12 years and 12 to <17 years). PK parameters, including steady-state maximum concentration (C max), area under the curve during the dosing interval, normalized by week (AUC/week), and apparent clearance normalized for body weight (CL/F/BW), were also compared across age groups.Results
All age groups effectively achieved mean IgG C trough above 7 g/l following fSCIG 10% administration. Total IgG exposures (mean C trough, C max, and AUC/week) marginally increased with age (all P < 0.05), while there was considerable variability within age groups. However, after total IgG baseline correction, there were no differences in any exposure parameters by age. CL/F/BW remained consistent across studies and age groups.Conclusion
fSCIG 10% effectively maintains C trough in IgG treatment-experienced patients with PID. The small age-related differences observed in serum total IgG PK are unlikely to be clinically significant and dose adjustments by age alone are not warranted.
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BibTeX
@article{li2026comparison,
title = {{Comparison of hyaluronidase-facilitated subcutaneous immunoglobulin 10% pharmacokinetics in pediatric and adult patients with primary immunodeficiency: an analysis of three phase 3 clinical trials.}},
author = {Zhaoyang Li and Alex Ballesteros-Perez},
journal = {Immunotherapy advances},
year = {2026},
month = oct,
doi = {10.1093/immadv/ltag022},
url = {https://europepmc.org/article/MED/42960290},
note = {CC BY},
}
RIS
TY - JOUR
TI - Comparison of hyaluronidase-facilitated subcutaneous immunoglobulin 10% pharmacokinetics in pediatric and adult patients with primary immunodeficiency: an analysis of three phase 3 clinical trials.
AU - Zhaoyang Li
AU - Alex Ballesteros-Perez
PY - 2026
DA - 2026/10/13
JO - Immunotherapy advances
DO - 10.1093/immadv/ltag022
UR - https://europepmc.org/article/MED/42960290
AB - Introduction Facilitated subcutaneous immunoglobulin (fSCIG) 10% is approved for the treatment of primary immunodeficiency (PID) in both pediatric and adult patients. However, it remains unclear whether there is a clinically meaningful difference in the pharmacokinetics (PK) of immunoglobulin G (IgG) between these two populations.Methods Serum total IgG concentrations in pediatric and adult patients (aged 3-80 years) with PID from three phase 3 clinical trials of fSCIG 10% were analyzed (NCT00814320, NCT01175213, NCT03277313). Serum total IgG trough concentrations (C trough) were compared against the conservative threshold for treatment effectiveness of 7 g/l, and between adult and pediatric patients (aged 2 to <17 years) and pediatric subgroups (2 to <12 years and 12 to <17 years). PK parameters, including steady-state maximum concentration (C max), area under the curve during the dosing interval, normalized by week (AUC/week), and apparent clearance normalized for body weight (CL/F/BW), were also compared across age groups.Results All age groups effectively achieved mean IgG C trough above 7 g/l following fSCIG 10% administration. Total IgG exposures (mean C trough, C max, and AUC/week) marginally increased with age (all P < 0.05), while there was considerable variability within age groups. However, after total IgG baseline correction, there were no differences in any exposure parameters by age. CL/F/BW remained consistent across studies and age groups.Conclusion fSCIG 10% effectively maintains C trough in IgG treatment-experienced patients with PID. The small age-related differences observed in serum total IgG PK are unlikely to be clinically significant and dose adjustments by age alone are not warranted.
SN - 2732-4303
ER -