Pharmacokinetics of a novel human intravenous immunoglobulin 10% in patients with primary immunodeficiency diseases : analysis of a phase III, multicentre, prospective, open-label study
| Autor: | Hans D. Ochs, Magdalena Strach, Anna Pituch-Noworolska, Laurenz Trawnicek, Grazyna Pulka, Sudhir Gupta, Michael Borte, James N. Moy, Roger H. Kobayashi, William Smits, Ai-Lan Kobayashi, Isaac Melamed, Alan P. Knutsen |
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| Jazyk: | angličtina |
| Rok vydání: | 2018 |
| Předmět: |
0301 basic medicine
Adult Male medicine.medical_specialty business.operation Adolescent Pharmaceutical Science Octapharma Gastroenterology Subclass 03 medical and health sciences Young Adult Pharmacokinetics Agammaglobulinemia Internal medicine medicine Humans Child Aged biology business.industry Common variable immunodeficiency Toxoid Immunoglobulins Intravenous Genetic Diseases X-Linked Middle Aged medicine.disease Primary and secondary antibodies 030104 developmental biology Common Variable Immunodeficiency Child Preschool Immunoglobulin G biology.protein Primary immunodeficiency Female Antibody business |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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