Levels of IgG subclasses 1-4 in BT595, a 10% IVIG: A sub-analysis of a clinical trial
Abstract
The 10% intravenous immunoglobulin (IVIG) BT595 was evaluated in an open-label, prospective, multicenter clinical trial (Trial 991; NCT02810444) to characterize IgG subclass pharmacokinetics as replacement therapy in patients with primary immunodeficiency (PID). Patients received BT595 at either a 3-week (Q3W) or 4-week (Q4W) dosing interval for approximately 12 months. Secondary endpoints included steady state trough concentrations and pharmacokinetic parameters of IgG subclasses 1-4 and total IgG. IgG subclass trough concentrations were assessed at baseline and at steady state prior to the 7th infusion (Q3W) or 5th infusion (Q4W). Pharmacokinetic parameters at steady state were determined in patients aged ≥6 years using serum samples collected predose and up to 28 days post infusion. At steady state, trough concentrations of total IgG and all IgG subclasses were comparable between BT595 and patients' previous IVIG therapy, indicating preservation of systemic IgG exposure following treatment switch. IgG subclass trough concentrations were stable across dosing regimens and age categories, with a proportional distribution closely matching physiological IgG composition. IgG1 and IgG2 accounted for the majority of total IgG, whereas IgG3 and IgG4 contributed smaller fractions, consistent with endogenous IgG and published IVIG data. Pharmacokinetic profiles of all IgG subclasses were consistent with those reported for licensed IVIG products. Maximum concentrations occurred…
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence.
Read the paper
Related studies
- Understanding the factors influencing fall armyworm (Spodoptera frugiperda J.E. Smith) damage in African smallholder maize fields and quantifying its impact on yield. A case study in Eastern Zimbabwe
- Alarming situation of emerging H5 and H7 avian influenza and effective control strategies
- Livestock and food security: vulnerability to population growth and climate change
- Atmosphere–ocean oxygen and productivity dynamics during early animal radiations
- Characterization of the global distribution and diversified plasmid reservoirs of the colistin resistance gene mcr-9
- The global seroprevalence of Toxoplasma gondii in pigs: A systematic review and meta-analysis
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.