Flebogamma® 5 % DIF Intravenous Immunoglobulin for Replacement Therapy in Children with Primary Immunodeficiency Diseases

Ballow, Mark; Pinciaro, Paul J.; Craig, Timothy; Kleiner, Gary; Moy, James N.; Ochs, Hans D.; Sleasman, John W.; Smits, William

doi:10.1007/s10875-016-0303-4

Cited by 8 publications

(4 citation statements)

References 28 publications

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“…In addition, the typical infections seen in pediatric patients with XLA [17,18] had a low frequency or were not reported at all in our pediatric subgroup. Ballow et al reported an upper CI of ≤ 30.3% for the unadjusted percent of infusions with a non-treatmentrelated infusional AE [19]. In the study of Melamed et al, 97 (26.4%) of the 368 total infusions were associated with an AE up to 72 h after the infusion (regardless of causality) [20] with an upper 95% CI of 0.304 (30.4%).…”

Section: Discussionmentioning

confidence: 98%

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BT595, a 10% Human Normal Immunoglobulin, for Replacement Therapy of Primary Immunodeficiency Disease: Results of a Subcohort Analysis in Children

et al. 2022

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Purpose To assess the efficacy, pharmacokinetics, and safety of a new, highly purified 10% IVIg (BT595, Yimmugo®) administered in children with PID. Methods This was an open-label, prospective, uncontrolled, multicenter Phase III pivotal trial. Among the 67 subjects in the trial were 18 pediatric patients aged 2 to 17 years with diagnosis of PID included in this analysis. They received doses between 0.2 and 0.8 g/kg body weight for approximately 12 months at intervals of either 3 or 4 weeks. Dosage and dosing interval were based on each patient’s pre-trial infusion schedule. The rates of acute serious bacterial infections (SBI), secondary efficacy, safety, and pharmacokinetic outcomes were evaluated. Results No SBI occurred in the pediatric population. Two hundred sixty infusions were administered to the 18 pediatric patients. The mean (SD) IgG trough level was 8.55 (1.67) g/L at baseline and 8.84 (2.17) g/L at the follow-up visit after the last BT595 infusion. At the single infusions respectively, the average mean IgG trough levels ranged between 8.52 and 10.58 g/L. More than 85% of all infusions administered were not associated with any infusional AE (start during or within 72 h post-infusion). None of the severe or serious AEs were related to the investigational medicinal product (IMP). No premedication was used. Thirteen children reached a maximum infusion rate between > 2.0 and 8 mL/kg/h; no AE with an onset during the infusion occurred at these infusion rates. Conclusion BT595 is effective, convenient, well tolerated, and safe for the treatment of children with PID. Trial registration EudraCT: 2015–003652-52; NCT02810444, registered June 23, 2016.

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Section: Discussionmentioning

confidence: 98%

“…Ballow et al reported an upper CI of ≤ 30.3% for the unadjusted percent of infusions with a non-treatment-related infusional AE [ 19 ]. In the study of Melamed et al, 97 (26.4%) of the 368 total infusions were associated with an AE up to 72 h after the infusion (regardless of causality) [ 20 ] with an upper 95% CI of 0.304 (30.4%).…”

Section: Discussionmentioning

confidence: 99%

BT595, a 10% Human Normal Immunoglobulin, for Replacement Therapy of Primary Immunodeficiency Disease: Results of a Subcohort Analysis in Children

et al. 2022

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“…To minimize infusion-related side effects [15–17], previous studies of IVIG products have increased infusion rates incrementally at intervals of 30 or 60 min [18, 19]. As infusion time is an important factor for patients, this study was prospectively designed to increase infusion rates incrementally at 15-min intervals, if tolerated, to shorten overall infusion times; as reported above, this approach resulted in mean infusion times of 1.9 h for Gammaplex 10% in adults, 2.8 h for Gammaplex 5% in adults, and 2.3 h for Gammaplex 10% in children.…”

Section: Discussionmentioning

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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“…Analizom vrednosti IgG, IgM i IgA praćen je efekat primenjene supstitucione terapije. Smatra se da se izuzetno niske vrednosti IgM i IgA kod gotovo svih pacijenata mogu objasniti karakteristikama samih formulacija imunoglobulina, u čijem se sastavu nalazi oko 97% IgG (23,24). Postoje i formule obogaćene IgA i IgM, ali one još uvek nisu našle primenu u lečenju CVID (25,26).…”

Section: Diskusijaunclassified

Clinical and laboratory parameter analysis in patients with common Variable Immunodeficiency

Krtinić¹,

Stojanović²

2022

Medicinski podmladak

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Introduction: Common Variable Immunodeficiency (CVID) is the most prevalent primary immunodeficiency in adult population. The diagnosis is based on low concentration of at least 2 immunoglobulin classes, mostly IgG, with low IgA and/or IgM. Beside recurrent infections, patients with CVID usually suffer from different respiratory, gastrointestinal, autoimmune and malignant diseases. Leading therapeutic approach to managing CVID is regular intravenous (IVIG) and subcutaneous (SCIG) immunoglobulin replacement therapy. Aim: The aim of the study was to analyze clinical and laboratory parameters in patients with CVID. Material and methods: The present study included 24 patients with CVID who were treated at Clinic of Allergy and Immunology, University Clinical Center of Serbia from 2012 to 2022. Demographic data, clinical and laboratory parameters were obtained from the patients' medical records. The concentrations of IgG, IgM and IgA were measured by nephelometry. Statistical analysis was performed using descriptive methods, Student t test for independent samples and Fisher exact test. Results: Respiratory manifestations were found in 70.8% of patients, gastrointestinal in 45.8%, autoimmune in 29.2% and malignancies in 20.8%. The presence of autoimmune diseases was the most common within the patients aged between 20 to 30 years, and it was statistically significantly higher comparing to other age groups (p = 0.014). Serum IgG concentration of 7.6 ± 2.7 g/l was measured. Statistically significantly higher IgG concentrations were observed in patients receiving SCIG (10.2 ± 1.6), compared to those receiving IVIG (6.7 ± 2.4) (t = -3.3, p = 0.003). Premedication was required in 44.4% of patients receiving IVIG. Conclusion: The most common complication of CVID are chronic lung diseases. Autoimmune diseases are the most frequently diagnosed in patients between the ages of 20 and 30. The use of SCIG is identified as better form of immunoglobulin replacement therapy. Total immunoglobulin serum concentration measuring in patients with recurrent infections and autoimmune diseases can contribute to timely diagnosis.

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Flebogamma® 5 % DIF Intravenous Immunoglobulin for Replacement Therapy in Children with Primary Immunodeficiency Diseases

Abstract: Flebogamma(®) 5 % DIF is efficacious and safe, has adequate pharmacokinetic properties, is well-tolerated, and maintains the profile of Flebogamma(®) 5 % for the treatment of children with primary humoral immunodeficiency diseases.

Cited by 8 publications

References 28 publications

BT595, a 10% Human Normal Immunoglobulin, for Replacement Therapy of Primary Immunodeficiency Disease: Results of a Subcohort Analysis in Children

BT595, a 10% Human Normal Immunoglobulin, for Replacement Therapy of Primary Immunodeficiency Disease: Results of a Subcohort Analysis in Children

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

Clinical and laboratory parameter analysis in patients with common Variable Immunodeficiency

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