Safety, efficacy and pharmacokinetics of a new 10% liquid intravenous immunoglobulin (IVIG) in patients with primary immunodeficiency.
J Clin Immunol
; 32(4): 663-9, 2012 Aug.
Article
em En
| MEDLINE
| ID: mdl-22392046
ABSTRACT
INTRODUCTION:
An investigational 10% liquid intravenous immunoglobulin (IVIG) was studied in 63 patients with primary immunodeficiency (PID) at 15 study sites.METHODS:
Patients were treated every 3 or 4 weeks with 254-1029 mg/kg/infusion of IVIG.RESULTS:
Overall, Biotest-IVIG infusions were well tolerated. The proportion of infusions that were associated with adverse events during infusion, and up to 72 h after infusion, including those unrelated to study product, was 27.7% with an upper 95% confidence limit ≤30.6%. Two serious bacterial infections (SBIs) were observed resulting in a serious bacterial infection rate of 0.035 per person per year and an upper one-sided 99% confidence limit of ≤0.136 SBI/patient/year. The number of days of work or school missed due to infection were relatively low at 2.28 days/patient/year. Two patients were hospitalized for infection producing a rate of 0.21 hospitalization days/patient/year. The IgG half-life was approximately 30 days with variation among individuals.CONCLUSIONS:
Pharmacokinetic parameters of specific antibody activities were essentially the same as those of total IgG. Biotest-IVIG is safe and effective in the treatment of PID.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Imunoglobulinas Intravenosas
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Deficiência de IgG
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Imunodeficiência de Variável Comum
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Agamaglobulinemia
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Doenças Genéticas Ligadas ao Cromossomo X
Limite:
Adolescent
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Adult
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Aged
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Child
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Ano de publicação:
2012
Tipo de documento:
Article