Pharmacokinetics of a novel human intravenous immunoglobulin 10% in patients with primary immunodeficiency diseases: Analysis of a phase III, multicentre, prospective, open-label study.
Eur J Pharm Sci
; 118: 80-86, 2018 Jun 15.
Article
en En
| MEDLINE
| ID: mdl-29522908
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 2-75â¯years with common variable immunodeficiency (nâ¯=â¯43) or X-linked agammaglobulinaemia (nâ¯=â¯8). Patients were treated with IVIG 10% every 3 (nâ¯=â¯21) or 4â¯weeks (nâ¯=â¯30) at a dose of 200-800â¯mg/kg for 12â¯months. Total immunoglobulin G (IgG) and subclass concentrations approximately doubled from pre- to 15â¯min post-infusion. The maximum concentration of total IgG (mean⯱â¯SD) was 21.82⯱â¯5.83â¯g/L in patients treated 3-weekly and 17.42⯱â¯3.34â¯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 12.2â¯g/L for patients on the 3-week schedule and between 8.10 and 8.65â¯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 (26.7-38.0â¯days). Median half-lives for specific antibodies ranged between 21.3 and 51.2â¯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.
Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Inmunoglobulinas Intravenosas
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Inmunodeficiencia Variable Común
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Agammaglobulinemia
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Enfermedades Genéticas Ligadas al Cromosoma X
Tipo de estudio:
Clinical_trials
Límite:
Adolescent
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Adult
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Aged
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Child
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Child, preschool
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
Eur J Pharm Sci
Asunto de la revista:
FARMACIA
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FARMACOLOGIA
/
QUIMICA
Año:
2018
Tipo del documento:
Article