Abstract
IntroductionAn investigational 10% liquid intravenous immunoglobulin (IVIG) was studied in 63 patients with primary immunodeficiency (PID) at 15 study sites.MethodsPatients were treated every 3 or 4 weeks with 254–1029 mg/kg/infusion of IVIG.ResultsOverall, 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.ConclusionsPharmacokinetic 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.
Highlights
An investigational 10% liquid intravenous immunoglobulin (IVIG) was studied in 63 patients with primary immunodeficiency (PID) at 15 study sites
We report here the results of a clinical trial of a new liquid 10% IVIG (Biotest-IVIG) in patients with primary immunodeficiency
Biotest-IVIG was manufactured from source plasma, fully screened for blood borne pathogens, by Cohn-Oncley fractionation followed by ion exchange chromatography [2, 3]
Summary
An investigational 10% liquid intravenous immunoglobulin (IVIG) was studied in 63 patients with primary immunodeficiency (PID) at 15 study sites. The first commercial human IgG preparations were restricted to intramuscular injection at relatively low doses, usually 25 mg/kg/week. In order to avoid the pain of intramuscular IgG injections and to administer larger doses, intravenous immunoglobulin products (IVIG) were developed. Periodic reports of hepatitis transmission and recognition that primary immunodeficient (PID) patients must be treated for a lifetime resulted in development of IVIG manufacturing procedures that inactivate or remove blood-borne pathogens. Manufacturing steps that enhance purity, minimize damage to IgG molecules, decrease the frequency of adverse reactions, and result in higher concentration liquid IVIG have been introduced. We report here the results of a clinical trial of a new liquid 10% IVIG (Biotest-IVIG) in patients with primary immunodeficiency
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