An Update on the Use of Immunoglobulin for the Treatment of Immunodeficiency Disorders

Albin, Stephanie; Cunningham‐Rundles, Charlotte

doi:10.2217/imt.14.67

Cited by 56 publications

(52 citation statements)

References 88 publications

(103 reference statements)

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“…Currently, both intravenous IgG (IVIG) and subcutaneous IgG (SCIG) are available, but IVIG therapy is more common than SCIG therapy (15). IVIG is usually recommended at a dose of 400–600 mg/kg every 3 or 4 weeks, and it is considered that an IgG level greater than 500 mg/dL might reduce infection and improve clinical outcomes in patients with PAD (161718). …”

Section: Introductionmentioning

confidence: 99%

Antibodies against Hepatitis A and Hepatitis B Virus in Intravenous Immunoglobulin Products

Lee

Kim

2016

J Korean Med Sci

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The worldwide seroprevalence of hepatitis A virus (HAV) and hepatitis B virus (HBV) has changed over the last two decades, indicating a declining incidence of HAV and HBV infections. Therefore, vaccinations against HAV and HBV are recommended for unimmunized people before traveling to an endemic area. Unfortunately, primary antibody deficiency (PAD) patients can only obtain humoral immunity through intravenous immunoglobulin G (IVIG) replacement and not from vaccination because of a defect in antibody production. However, few studies have analyzed the titers of antibodies against HAV or HBV in IVIG products. In this study, the titers of anti-HAV and anti-HBs antibodies were measured in nineteen lots of IVIG products from five manufacturers from three countries (A, B from Korea; C, D from Japan; and E from the USA), and trough titers in plasma were estimated. Concentrations of anti-HAV antibody ranged from 1,888–8,927 mIU/mL and estimated trough titers exceeded the minimal protective value in all evaluated IVIG products. Concentrations of anti-HBs antibody ranged from 438–965 mIU/mL in products A and B and were 157, 123, and 1,945 mIU/mL in products C, D, and E, respectively. Estimated trough titers in products A, B, and E exceeded the minimal protective value but those in products C and D did not reach this threshold. These data demonstrated that available IVIG products generally provide sufficient antibodies against HAV and HBV to protect patients with PAD, although the trough concentrations of anti-HBs antibody in two IVIG products did not reach the minimum protective value.

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Section: Introductionmentioning

confidence: 99%

Antibodies against Hepatitis A and Hepatitis B Virus in Intravenous Immunoglobulin Products

Lee

Kim

2016

J Korean Med Sci

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“…efficacy . pharmacokinetics Introduction Immunoglobulin (IG) supplementation has been the standard treatment for patients with disorders of antibody production due to B cell or combined B and T cell abnormalities (PIDD) [1][2][3][4][5]. Regularly scheduled infusions of IG replace or supplement antibodies that decrease the risk of the serious bacterial and viral infections experienced by PIDD patients [6][7][8].…”

mentioning

confidence: 99%

Efficacy, Safety, and Pharmacokinetics of a New 10 % Liquid Intravenous Immunoglobulin Containing High Titer Neutralizing Antibody to RSV and Other Respiratory Viruses in Subjects with Primary Immunodeficiency Disease

et al. 2016

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PurposeImmune globulins for IgG supplementation have been produced for over 35 years with essentially no differentiating features regarding their specific antibody composition. Furthermore, the compositions of plasma donor pools used for IG manufacturing are not standardized. While all immune globulin products meet the specifications set by the US FDA for antibodies to pathogens like measles and polio, they have variable levels of antibodies to other important viruses and infectious pathogens, particularly respiratory syncytial virus (RSV).MethodsAn IVIG was developed that satisfies the requirements for treating patients with primary immune deficiency disease (PIDD) and also has standardized elevated levels of RSV neutralizing antibodies (RI-002). Plasma donors who have naturally occurring high circulating levels of neutralizing anti-RSV antibody were selected as the source for manufacturing IVIG to treat patients with PIDD to prevent serious bacterial infections. While the introduction of the monoclonal antibody Palivizumab has had a dramatic impact in diminishing the burden of RSV disease in the pediatric population, it does not meet the standards for replacing the deficient immune compartments of patients with PIDD.ResultsFifty-nine patients with PIDD at 9 different sites across the US were enrolled in this study and received regular infusions of RI-002 over the course of 1 year.ConclusionsThere were zero serious bacterial infections, thus meeting the primary endpoint for this trial. The secondary endpoints including days missed from work due to infection, unscheduled visits to the physician, and days of hospitalization due to infection compared favorably to published reports of other IVIG products.

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“…The use of pooled, plasma-derived human IG has become a critical therapy in clinical medicine [17][18][19] . While originally indicated as a plasma protein augmentation therapy for patients with PIDD and some secondary immunodeficiency diseases, IG has also been shown to exhibit other clinical benefits, many stemming from its anti-inflammatory and immunomodulatory effects 20,21 .…”

Section: Discussionmentioning

confidence: 99%

Plasma Donors in the Southwestern United States Positively Contribute to the Diverse Therapeutic Antibody Profile of Immune Globulin Products

Ciencewicki

Schouest

Gierman

et al. 2020

Sci Rep

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Human-plasma-derived immune globulin (iG) is used in augmentation therapy to provide protective levels of antibodies to patients with primary immune deficiency diseases (PIDD) and for prophylaxis against infectious diseases. To maintain the breadth of antibodies necessary for clinical protection, it is important to understand regional patterns of antibody seroprevalence in source plasma from which IG products are manufactured. In this study, source plasma from donation centers in various locations of the Southwestern quarter of the United States was surveyed for antibody titers to hepatitis A virus (HAV), measles virus (MeV), and cytomegalovirus (CMV). A broad range of anti-HAV Ig plasma titers was observed among these centers, with some centers exhibiting 3-5 times the titers of the others. Minor to no differences were observed for levels of anti-MeV and anti-CMV, respectively. Importantly, elevated anti-HAV Ig titers were broadly observed across plasma units obtained from the centers exhibiting high titers, indicative of a potential regional phenomenon among donors as opposed to few donors with singularly high titers. Plasma from these high-titer centers conferred significantly greater neutralization against HAV in vitro. The outcomes of this study give a glimpse of the antibody diversity inherent in human plasma used to manufacture IG products..

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An Update on the Use of Immunoglobulin for the Treatment of Immunodeficiency Disorders

Cited by 56 publications

References 88 publications

Antibodies against Hepatitis A and Hepatitis B Virus in Intravenous Immunoglobulin Products

Antibodies against Hepatitis A and Hepatitis B Virus in Intravenous Immunoglobulin Products

Efficacy, Safety, and Pharmacokinetics of a New 10 % Liquid Intravenous Immunoglobulin Containing High Titer Neutralizing Antibody to RSV and Other Respiratory Viruses in Subjects with Primary Immunodeficiency Disease

Plasma Donors in the Southwestern United States Positively Contribute to the Diverse Therapeutic Antibody Profile of Immune Globulin Products

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