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

Saeedian, Monika; Randhawa, Inderpal

doi:10.1159/000363445

Cited by 22 publications

(16 citation statements)

References 70 publications

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“…5,116,117 The latest products are safe from the standpoint of infection transmission; they are stabilized with amino acids rather than sugars, have lower sodium concentrations and IgA content under 50mg/ml. 5,16,48,114 …”

Section: Productionmentioning

confidence: 99%

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II Brazilian Consensus on the use of human immunoglobulin in patients with primary immunodeficiencies

Goudouris

Silva

Ouricuri

et al. 2017

Einstein (São Paulo)

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In the last few years, new primary immunodeficiencies and genetic defects have been described. Recently, immunoglobulin products with improved compositions and for subcutaneous use have become available in Brazil. In order to guide physicians on the use of human immunoglobulin to treat primary immunodeficiencies, based on a narrative literature review and their professional experience, the members of the Primary Immunodeficiency Group of the Brazilian Society of Allergy and Immunology prepared an updated document of the 1st Brazilian Consensus, published in 2010. The document presents new knowledge about the indications and efficacy of immunoglobulin therapy in primary immunodeficiencies, relevant production-related aspects, mode of use (routes of administration, pharmacokinetics, doses and intervals), adverse events (major, prevention, treatment and reporting), patient monitoring, presentations available and how to have access to this therapeutic resource in Brazil.

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Section: Productionmentioning

confidence: 99%

“…Chart 7 describes the most relevant factors according to the associated morbidity, and chart 8 lists the products available to facilitate this choice. 5,117,147 …”

Section: Adverse Effects Prevention Treatment and Reportingmentioning

confidence: 99%

II Brazilian Consensus on the use of human immunoglobulin in patients with primary immunodeficiencies

Goudouris

Silva

Ouricuri

et al. 2017

Einstein (São Paulo)

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“…In the 1980s, intravenous immunoglobulin (IVIG) became available in the USA and became the most common treatment for PID patients with impaired humoral immunity [4–6]. Currently, IVIG is available at concentrations of 3%, 5%, 6%, 9%, 10%, and 12%, with more products available at 10% than at any other concentration [7, 8]. …”

Section: Introductionmentioning

confidence: 99%

Evaluation of the Safety, Tolerability, and Pharmacokinetics of Gammaplex® 10% Versus Gammaplex® 5% in Subjects with Primary Immunodeficiency

et al. 2017

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PurposeThis phase 3, multicenter, open-label, randomized, two-period, crossover bioequivalence trial evaluated the safety, tolerability, and pharmacokinetics of intravenous immunoglobulins (IVIGs) Gammaplex 5% and Gammaplex 10% in 33 adults and 15 children with primary immunodeficiency diseases (PIDs).MethodsEligible adults received five Gammaplex 5% infusions followed by five Gammaplex 10% infusions, or vice versa, stratified by a 21- or 28-day dosing regimen. Pediatric subjects received five Gammaplex 10% infusions only.ResultsThe primary objective, to demonstrate the bioequivalence of Gammaplex 10% and Gammaplex 5% at the 28-day dosing interval, was met based on the Gammaplex 10%/Gammaplex 5% ratio of area under the concentration versus time curve (AUC0–28) values. Throughout the study, total immunoglobulin G trough levels were well maintained, with total values generally ≥600 mg/dL (minimum level for study inclusion). At the dosing schedules and infusion rates used in this study, safety and tolerability were comparable and acceptable in adult and pediatric PID subjects treated with Gammaplex 10% and 5%.ConclusionsIn this study, the first direct comparison of 5% IVIG and 10% IVIG products in PID subjects, the pharmacokinetic analysis demonstrated bioequivalence of Gammaplex 10% and Gammaplex 5% at the 28-day dosing interval. The Gammaplex 10% formulation was safe and well tolerated in pediatric and adult PID subjects. Based on the results from this bridging study in PID subjects, Gammaplex 10% could be expected to have a therapeutic effect similar to the licensed Gammaplex 5%, which has demonstrated efficacy and tolerability in patients with PID and idiopathic thrombocytopenic purpura.Electronic supplementary materialThe online version of this article (doi:10.1007/s10875-017-0383-9) contains supplementary material, which is available to authorized users.

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“…Intravenous and subcutaneous immunoglobulin treatment has been proven to be effective in patients with primary hypogammaglobulinemia [23]. Zaupper et al [24 ]reported the resolution of cardiac-related PLE symptoms after high-dose (1 g/kg/4 weeks) intravenous immunoglobulin treatment.…”

Section: Discussionmentioning

confidence: 99%

Secondary Combined Immunodeficiency in Pediatric Patients after the Fontan Operation: Three Case Reports

Hlaváčková

LiskaMartin²,

Jičínská³

et al. 2016

Int Arch Allergy Immunol

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The Fontan operation or total cavopulmonal connection (TCPC) is a palliative surgical correction of rare and complex inborn cardiac malformations that are characterized by univentricular circulation. Protein-losing enteropathy (PLE) develops in 4-13% of patients after the Fontan procedure. Fontan-related PLE leads to secondary combined immunodeficiency marked by hypogammaglobulinemia and predominantly CD4⁺ lymphocytopenia. Here, we present 3 case reports of patients with secondary immunodeficiency after the Fontan operation. The severity of hypogammaglobulinemia correlated with the nature of the infectious complications; however, clinical manifestations of T cell deficiency such as severe viral or opportunistic infections were not observed. The clinical consequences of the secondary combined immunodeficiency were modified by immunoglobulin replacement treatment and antibiotic prophylaxis. Heart transplantation led to the resolution of PLE signs and the restitution of IgG levels in 1 transplanted patient. Our experience shows that the immunological follow-up was delayed in all 3 patients. We suggest that all patients should be followed regularly by a clinical immunologist after the Fontan surgery.

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

Cited by 22 publications

References 70 publications

II Brazilian Consensus on the use of human immunoglobulin in patients with primary immunodeficiencies

II Brazilian Consensus on the use of human immunoglobulin in patients with primary immunodeficiencies

Evaluation of the Safety, Tolerability, and Pharmacokinetics of Gammaplex® 10% Versus Gammaplex® 5% in Subjects with Primary Immunodeficiency

Secondary Combined Immunodeficiency in Pediatric Patients after the Fontan Operation: Three Case Reports

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