Levels of IgG subclasses 1-4 in BT595, a 10% IVIG: A sub-analysis of a clinical trial.
PLoS OneSep 25, 2026 (epub)
Clinical ResearchAllergy & Immunology
Fabian Bohländer, Silke Aigner, Joachim Schütze et al.
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In 30 seconds
This multicenter, open-label clinical trial evaluated the pharmacokinetics of IgG subclasses in patients with primary immunodeficiency receiving 10% IVIG BT595. Patients were treated with either a 3-week or 4-week dosing interval for approximately 12 months. At steady state, trough concentrations of total IgG and all subclasses were comparable to previous IVIG therapies, indicating effective systemic IgG exposure.
Key findings
- Trough concentrations of total IgG and all subclasses were comparable between BT595 and previous IVIG therapy.
- IgG1 and IgG2 comprised the majority of total IgG, while IgG3 and IgG4 were present in smaller fractions.
- Mean concentrations and Cmax values were higher with Q3W dosing compared to Q4W dosing.
- Estimated half-life values for IgG2 and IgG4 were numerically prolonged under Q4W dosing.
Why it matters
Understanding the pharmacokinetics of IgG subclasses in IVIG therapy is crucial for optimizing treatment in patients with primary immunodeficiency, ensuring adequate immune support and minimizing complications.