Abstract
Intravenous immunoglobulin (IVIG) therapy is commonly used to treat patients with primary antibody deficiency. This prospective, open-label, non-randomised, multicentre, phase III trial investigated the pharmacokinetics of a new 10% liquid IVIG product (panzyga®; Octapharma) in 51 patients aged 2–75 years with common variable immunodeficiency (n = 43) or X-linked agammaglobulinaemia (n = 8). Patients were treated with IVIG 10% every 3 (n = 21) or 4 weeks (n = 30) at a dose of 200–800 mg/kg for 12 months. Total immunoglobulin G (IgG) and subclass concentrations approximately doubled from pre- to 15 min post-infusion. The maximum concentration of total IgG (mean ± SD) was 21.82 ± 5.83 g/L in patients treated 3-weekly and 17.42 ± 3.34 g/L in patients treated 4-weekly. Median trough IgG concentrations were nearly constant over the course of the study, remaining between 11.0 and 12.2 g/L for patients on the 3-week schedule and between 8.10 and 8.65 g/L for patients on the 4-week schedule. The median terminal half-life of total IgG was 36.1 (range 18.5–65.9) days, with generally similar values for the IgG subclasses (26.7–38.0 days). Median half-lives for specific antibodies ranged between 21.3 and 51.2 days for anti-cytomegalovirus, anti-Haemophilus influenzae, anti-measles, anti-tetanus toxoid, anti-varicella zoster virus antibodies, and anti-Streptococcus pneumoniae subtype antibodies. Overall, IVIG 10% demonstrated pharmacokinetic properties similar to those of other commercial IVIG 10% preparations and 3- or 4-weekly administration achieved sufficient concentrations of IgG, IgG subclasses, and specific antibodies, exceeding the recommended level needed to effectively prevent serious bacterial infections.
Highlights
Primary immunodeficiency diseases (PID) are a heterogeneous group of disorders characterised by an inability of the immune system to mount a sufficient response to invading pathogens (Durandy et al, 2013; Grimbacher et al, 2016; Picard et al, 2018)
Out of the 51 patients enrolled in the study, 43 patients (84.3%) were diagnosed with common variable immune deficiency (CVID) and eight patients (15.7%) were diagnosed with X-linked agammaglobulinaemia (XLA)
This study characterises the pharmacokinetics of total immunoglobulin G (IgG), IgG subclasses and specific antibodies after administration of Intravenous immunoglobulin (IVIG) 10% in patients with predominant antibody deficiency
Summary
Primary immunodeficiency diseases (PID) are a heterogeneous group of disorders characterised by an inability of the immune system to mount a sufficient response to invading pathogens (Durandy et al, 2013; Grimbacher et al, 2016; Picard et al, 2018). Antibody deficiencies requiring IgG replacement therapy, such as agammaglobulinaemia and common variable immune deficiency (CVID), are the most common forms of PID (Bonagura, 2013). Available intravenous immunoglobulin (IVIG) products include older lyophilised formulations, along with 5% and 10% liquid formulations. Lyophilised formulations take time to reconstitute, and 5% liquid formulations require higher volumes of fluid to be administered, which can be critical in patients with significant cardiac or renal disease, and longer infusion times (Stein, 2010). 10% liquid formulations require smaller volumes and have shorter infusion times
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
