{
  "abstract": "Introduction\n\nFacilitated 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\n\nSerum 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\n\nAll 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\n\nfSCIG 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.",
  "abstract_shown": true,
  "affiliations": [
    "Clinical Pharmacology & Early Clinical Development, Takeda Development Center Americas, Inc., Cambridge, MA, United States.",
    "Clinical Pharmacology, Certara Strategic Consulting, Certara USA, Inc., Radnor, PA, United States."
  ],
  "article_type": "research article",
  "arxiv": null,
  "author_total": 2,
  "authors": [
    {
      "affs": [
        0
      ],
      "name": "Zhaoyang Li",
      "orcid": "0000-0003-4625-1107"
    },
    {
      "affs": [
        1
      ],
      "name": "Alex Ballesteros-Perez",
      "orcid": "0009-0002-8047-7185"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/9899rmjk35hy8.bib",
  "cited_by": 0,
  "doi": "10.1093/immadv/ltag022",
  "fulltext_url": "https://europepmc.org/articles/PMC13718816",
  "id": "9899rmjk35hy8",
  "issns": [
    "2732-4303"
  ],
  "landing_url": "https://europepmc.org/article/MED/42960290",
  "language": "eng",
  "licence": "CC-BY",
  "licence_label": "CC BY",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "heading",
      "AcademicSubjects/MED00730"
    ],
    [
      "heading",
      "Research Article"
    ],
    [
      "openalex",
      "2403|Immunodeficiency and Autoimmune Disorders"
    ]
  ],
  "openalex": "W7221622383",
  "pdf_url": "https://europepmc.org/articles/PMC13718816?pdf=render",
  "pmcid": "PMC13718816",
  "pmid": "42960290",
  "published": "2026-10-13",
  "publisher": "Oxford University Press",
  "ris": "https://research.draconitic.com/paper/9899rmjk35hy8.ris",
  "sources": [
    {
      "first_seen": "2026-11-01T00:20:52Z",
      "native_id": "MED:42960290",
      "source": "europepmc",
      "url": "https://europepmc.org/article/MED/42960290"
    },
    {
      "first_seen": "2026-11-02T12:22:46Z",
      "native_id": "PMC13718816",
      "source": "pmc",
      "url": "https://doi.org/10.1093/immadv/ltag022"
    }
  ],
  "subjects": [
    {
      "field": "biology",
      "origin": "openalex:2403|Immunodeficiency and Autoimmune Disorders",
      "subfield": "immunology"
    }
  ],
  "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.",
  "title_text": "Comparison of hyaluronidase-facilitated subcutaneous immunoglobulin 10% pharmacokinetics in pediatric and adult patients with primary immunodeficiency: an analysis of three phase 3 clinical trials.",
  "type": "peer-reviewed",
  "updated_at": "2026-11-02T12:22:46Z",
  "url": "https://research.draconitic.com/paper/9899rmjk35hy8",
  "venue": "Immunotherapy advances",
  "versions": []
}