Safety, Efficacy and Pharmacokinetics of a New 10% Liquid Intravenous Immunoglobulin (IVIG) in Patients with Primary Immunodeficiency

Wasserman, Richard L.; Church, Joseph A.; Stein, Mark R.; Moy, James N.; White, Martha V.; Strausbaugh, Steven; Schroeder, Harry W.; Ballow, Mark; Harris, James B.; Melamed, Isaac; Elkayam, David; Lumry, William R.; Suez, Daniel; Rehman, Syed M.

doi:10.1007/s10875-012-9656-5

Cited by 46 publications

(45 citation statements)

References 15 publications

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“…Table 1 summarizes results from recent IVIG clinical trials (Stein et al 2009;Berger et al 2010;Moy et al 2010;Wasserman et al 2012). The number of patients in each trial ranged from 46 to 80 and the mean dose per patient was 461-500 mg/kg.…”

Section: Ivig In Pidmentioning

confidence: 99%

The history and evolution of immunoglobulin products and their clinical indications

Hooper¹

2015

LymphoSign Journal

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The history of providing antibodies to treat diseases began in the 19th century with the discovery of tetanus and diphtheria toxins and the demonstration that immunity to tetanus and diphtheria infections could be transferred by immune sera. Characterization of the mediators of this immunity resulted in the discovery that antibodies are proteins that can be isolated and used to protect against infectious diseases. Development of a method to isolate antibodies from human plasma that could be safely injected into people initiated the development of human gamma globulin preparations to provide antibodies to patients with inherited antibody deficiencies. To overcome the limitations imposed by intramuscular injection of gamma globulin, intravenous gamma globulin preparations were developed that began to be used in a wide variety of clinical conditions. Thus the original clinical indication for infection prevention was expanded to several other indications that employ large doses to suppress inflammatory and autoimmune disorders. The most recent development in immunoglobulin therapy is the production of concentrated immune globulins for subcutaneous injection. Home infusions of subcutaneous immunoglobulin are increasingly used to treat immunodeficient patients and are being studied for other clinical applications.

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Section: Ivig In Pidmentioning

confidence: 99%

The history and evolution of immunoglobulin products and their clinical indications

Hooper¹

2015

LymphoSign Journal

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“…[8][9][10] Despite the importance of IVIGs in inducing passive protection against invasive bacteria, few studies have quantified antipathogen antibody levels in medicinal IVIGs 11,12 or patients. [13][14][15] No clinical correlation with protective trough plasma titers has been performed to assess the protective capacity of the antipneumococcal titer in IVIG. 8,12 This is the first prospective study to measure both total IgG and trough and peak levels of specific antipneumococcal capsular polysaccharide antibodies (PnPsAbs) against 16 serotypes in IVIGtreated children with PID (7 successive IVIG infusions).…”

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confidence: 99%

Pneumococcal Antibody Levels in Children With PID Receiving Immunoglobulin

et al. 2014

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OBJECTIVES: Clinical data are lacking on optimal levels of specific antipneumococcal antibodies (PnPsAbs) in patients with primary immunodeficiency (PID) receiving intravenous immunoglobulin (IVIG) replacement. Objectives were to conduct a prospective multicenter study providing data on total immunoglobulin G (IgG) and peak/trough levels of PnPsAbs specifically targeting the 16 most prevalent pneumococcal serotypes in IVIG-treated children with PID; to compare trough PnPsAb levels with those measured in healthy adults and the IVIG product; and to evaluate PnPsAb protection correlates with thresholds based on World Health Organization. METHODS: Patients received 7 consecutive IVIG infusions. Total IgG and PnPsAb levels were determined on plasma samples obtained before and after infusion. RESULTS: Twenty-two children with PID were treated with IVIG (mean weekly dose: 0.10 g/kg). The mean trough and peak levels of total IgG were 7.77 and 13.93 g/L, respectively. Trough and peak geometric mean concentrations and distribution curves differed between serotypes and showed wide dispersion (0.17–7.96 µg/mL). In patients (89%–100%), antibodies against most serotypes reached trough levels ≥0.2 µg/mL, a threshold considered protective against invasive pneumococcal infection. For several serotypes, trough levels reached ≥1.0 to 1.3 µg/mL, the level found in adults. Trough geometric mean concentrations correlated well with the PnPsAb contents of the IVIG product. CONCLUSIONS: In IVIG-treated children with PID, protective PnPsAb levels for most pathogenic serotypes were obtained. A correlation was observed between PnPsAb levels in patients and in the IVIG product. This offers the potential to improve infection prevention by adapting the IVIG product and dose according to epidemiology.

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“…Cold ethanol fractionation, S/D inactivation, and nanofiltration are incorporated into the manufacturing process [64]. …”

Section: Specific Ivig Productsmentioning

confidence: 99%

Immunoglobulin Replacement Therapy: A Twenty-Year Review and Current Update

Saeedian

Randhawa

2014

Int Arch Allergy Immunol

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Objective: The expansion of immunoglobulin replacement to multiple disease entities marks a decade-long advancement in immune therapy. Parallel to its extension, the characteristics and composition of immunoglobulin products have diversified. The aim of this study was to summarize a 20-year comprehensive literature review of currently commercially available immunoglobulin products, particularly examining individual product properties in a comparative format. Data Sources/Study Selections: The literature review was performed using PubMed and Ovid, screening a time span of 2 decades. Both authors reviewed the obtained articles for acceptable quality, and the selection was narrowed down based on criteria for randomized clinical and therapeutic trials. Results: Product-specific characteristics in terms of purification strategy, stabilizers, composition, and viral inactivation were found among the immunoglobulin products investigated. Such differing characteristics manifest in their variable clinical safety and efficacy as assessed by the comparative product analysis. In subgroups of patients, subcutaneous immunoglobulin therapy may be an alternative to intravenous immunoglobulin (IVIG) therapy with an equal efficacy and a lower number of systemic adverse events. Conclusion: Only few comprehensive clinical synopses are available to clearly demonstrate the differences in IVIG products despite the widespread clinical use of the therapy. This review defines significant characteristics of individual immunoglobulin products, noting important differences in product development and application and allowing informed clinical decisions to match a product with patients' risk factors and comorbidity. This balanced approach to gammaglobulin replacement therapy is imperative to produce the highest clinical efficacy and lowest number of adverse events.

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Safety, Efficacy and Pharmacokinetics of a New 10% Liquid Intravenous Immunoglobulin (IVIG) in Patients with Primary Immunodeficiency

Cited by 46 publications

References 15 publications

The history and evolution of immunoglobulin products and their clinical indications

The history and evolution of immunoglobulin products and their clinical indications

Pneumococcal Antibody Levels in Children With PID Receiving Immunoglobulin

Immunoglobulin Replacement Therapy: A Twenty-Year Review and Current Update

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