Efficacy and safety of a new immunoglobulin G product, Gammaplex®, in primary immunodeficiency diseases

Moy, James N.; Scharenberg, Andy; Stein, Mark R.; Suez, Daniel; Roberts, Robert L.; Levy, Robyn J.; Ballow, Mark; Fasano, Mary Beth; Dash, C. H.; Leach, Samantha

doi:10.1111/j.1365-2249.2010.04247.x

Cited by 19 publications

(26 citation statements)

References 15 publications

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“…While published data on the incidence of SABIs in young children treated with IVIG are limited, these results are broadly in agreement with those published for another IVIG product in which a SABI event rate of 0·11 per subject per year (upper one‐sided 99% CI = 0·37) was reported . Additional analyses of SABI rates were performed by combining data from the present study with data from a previous study of Gammaplex 5% in 50 predominantly adult subjects with PID . As no SABIs were reported in the previous study, the mean SABI event rate per subject per year for the combined patient population ( n = 75) is 0·03 (upper one‐sided 99% CI = 0·12).…”

Section: Discussionsupporting

confidence: 89%

Efficacy and safety of Gammaplex® 5% in children and adolescents with primary immunodeficiency diseases

Melamed

Gupta

Bobbitt

et al. 2016

Clinical and Experimental Immunology

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SummaryThis open-label multi-centre study evaluated Gammaplex V R 5%, a human intravenous immunoglobulin (IVIG) 5% liquid, in 25 children and adolescent patients (aged 3-16 years) with primary immunodeficiency diseases (PIDs). Subjects received Gammaplex 5% (at doses of 300-800 mg/kg/infusion) for 12 months, with a 3-month follow-up. The primary efficacy end-point was the incidence of serious acute bacterial infections (SABIs) during the 12-month treatment period. Secondary objectives assessed safety and tolerability. Nineteen males and six females were treated using the same infusion schedule as their prior IVIG treatment (14 and 11 subjects on 21-and 28-day dosing schedules, respectively). Two SABIs of pneumonia were reported, resulting in an annual SABI event rate of 0Á09 [upper one-sided 99% confidence interval (CI) 5 0Á36]. Twenty-one subjects (84%) experienced ! 1 infection during the study, with a median infective episode per subject/year of 3Á08 (range 5 0-10Á4). Sixteen subjects (64%) missed ! 1 day of nursery or school because of infection or other illness. All trough immunoglobulin G levels exceeded 7Á00 g/l after 15 weeks (mean 5 9Á69 g/l; range 5 7Á04-15Á35 g/l). Product-related adverse events occurred in 14 subjects (56%); none were serious. Of 368 total infusions, 97 (26%) were associated temporally with an adverse event ( 72 h after infusion), regardless of causality. Laboratory test results and adverse-reaction data showed no evidence of product-related haemolysis or thromboembolic events. These data demonstrate that Gammaplex 5% is effective in preventing SABIs and well tolerated in children and adolescents with PID.

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Section: Discussionsupporting

confidence: 89%

Efficacy and safety of Gammaplex® 5% in children and adolescents with primary immunodeficiency diseases

Melamed

Gupta

Bobbitt

et al. 2016

Clinical and Experimental Immunology

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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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“…Previous studies of Gammaplex 5% demonstrated efficacy in preventing serious acute bacterial infections (SABIs) and demonstrated tolerability both in patients with PID [11, 12] and those with ITP [13]. Like Gammaplex 5% (Gammaplex [5%] 5 g in 100 mL), Gammaplex 10% (Gammaplex [10%] 10 g in 100 mL) is a ready-prepared solution for IV administration containing the active ingredient human normal IgG.…”

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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Efficacy and safety of a new immunoglobulin G product, Gammaplex®, in primary immunodeficiency diseases

Cited by 19 publications

References 15 publications

Efficacy and safety of Gammaplex® 5% in children and adolescents with primary immunodeficiency diseases

Efficacy and safety of Gammaplex® 5% in children and adolescents with primary immunodeficiency diseases

The history and evolution of immunoglobulin products and their clinical indications

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

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