ArticleJournal of clinical immunology2013
Bioavailability of IgG administered by the subcutaneous route.
Article in Journal of clinical immunology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers, 1 of them a synthesis that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
32 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Population Pharmacokinetics and Pharmacodynamics of Immunoglobulins: A Systematic Review.Clinical pharmacokinetics · 2026Pooled it
- A phase 2 randomized trial of safety and pharmacokinetics of IgPro20 and IgPro10 in patients with diffuse cutaneous systemic sclerosis.Rheumatology (Oxford, England) · 2025Trial
- Long-term safety and tolerability of hyaluronidase-facilitated subcutaneous immunoglobulin 10% as maintenance therapy for chronic inflammatory demyelinating polyradiculoneuropathy: Results from the ADVANCE-CIDP 3 trial.Journal of the peripheral nervous system : JPNS · 2024Trial
- Long-term safety and efficacy of subcutaneous immunoglobulin IgPro20 in CIDP: PATH extension study.Neurology(R) neuroimmunology & neuroinflammation · 2019Trial
- Efficacy, safety, tolerability and pharmacokinetics of a novel human immune globulin subcutaneous, 20%: a Phase 2/3 study in Europe in patients with primary immunodeficiencies.Clinical and experimental immunology · 2017Trial
- Efficacy and tolerability of 16% subcutaneous immunoglobulin compared with 20% subcutaneous immunoglobulin in primary antibody deficiency.Clinical and experimental immunology · 2015Trial
- Switching From Intravenous to Subcutaneous Immunoglobulin Maintenance Treatment in Chronic Inflammatory Demyelinating Polyradiculoneuropathy.Journal of the peripheral nervous system : JPNS · 2026Article
- Switch from Intravenous to Subcutaneous Immunoglobulin in CIDP and MMN: 12 Months Results from an Observational Study.Neurology and therapy · 2026Article
- Mechanical versus Electronic Infusion Systems in Subcutaneous Immunoglobulin Therapy: A Structured Literature Review of Infusion-Site Reactions and Device Performance.Medical devices (Auckland, N.Z.) · 2026Review
- Review
- Cerebellar tumefactive demyelination in MOGAD: a case report on diagnostic challenges and immunotherapeutic strategy.Frontiers in immunology · 2025Article
- Activated phosphoinositide 3-kinase delta syndrome: Pathogenesis, clinical manifestations, and treatment.Pediatric discovery · 2024Review
- Immunomodulatory effects of intravenous and subcutaneous immunoglobulin in chronic inflammatory demyelinating polyneuropathy: An observational study.European journal of neurology · 2024Observational
- Immunoglobulin therapies for primary immunodeficiency diseases (part 2): considerations for dosing strategies.Immunotherapy · 2024Review
- In-line warming reduces in-line pressure of subcutaneous infusion of concentrated immunoglobulins.Drug delivery and translational research · 2023Article
- Subcutaneous immunoglobulins in chronic lymphocytic leukemia with secondary antibody deficiency. A monocentric experience during Covid-19 pandemics.Hematological oncology · 2022Article
- Subcutaneous immunoglobulin treatment for chronic inflammatory demyelinating polyneuropathy.Muscle & nerve · 2021Review
- Steady-State Serum IgG Trough Levels Are Adequate for Pharmacokinetic Assessment in Patients with Immunodeficiencies Receiving Subcutaneous Immune Globulin.Journal of clinical immunology · 2021Article
- Intravenous immunoglobulin to prevent myasthenic crisis after thymectomy and other procedures can be omitted in patients with well-controlled myasthenia gravis.Therapeutic advances in neurological disorders · 2019Article
- Retrospective correlation analysis of plasma Immunoglobulin G and clinical performance in CIDP.PeerJ · 2019Article
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeUS licensing studies of subcutaneous IgG (SCIG) calculate dose adjustments necessary to achieve area under the curve (AUC) of serum IgG vs. time on SCIG that is non-inferior to that on intravenous IgG (IVIG), within the FDA-set limit of ±20%. The results are interpreted as showing that different SCIGs differ in bioavailability. We used three approaches to determine if the bioavailabilities were actually different.
methodsDose adjustments and AUCs from published licensing studies were used to calculate bioavailabilities using the formula: Bioavailability (% of IVIG) = AUC(SCIG) ÷ AUC(IVIG) x 1/Dose Adjustment. We also compared the increment in serum IgG concentration achieved with varying doses of SCIG in recent meta-analyses with the increment with different doses of IVIG, and determined the serum IgG concentrations when patients switched SCIG products at the same dose.
resultsThe actual bioavailabilities were: Gamunex® 65.0%, Hizentra® 65.5%, Gammagard® 67.2%, Vivaglobin® 69.0%. Regression analyses of serum IgG vs. dose showed that the mean increase in serum IgG resulting from a 100 mg/kg/month increment in SCIG dosing was 69.4% of the increase with the same increment in IVIG dosing (84 mg/dL vs. 121 mg/dL). Patients switching SCIG preparations at the same dose had no change in serum IgG levels, confirming that bioavailabilities of the SCIG preparations did not differ.
conclusionsDecreased bioavailability appears to be a basic property of SCIG and not a result of any manufacturing process or concentration. Because serum IgG levels do not vary with different SCIG products at the same dose, adjustments are not necessary when switching products.
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