Comparison of high‐dose intravenous immunoglobulin (<scp>IVIG</scp>) in a 5% and a 10% solution does not reveal a significantly different spectrum of side‐effects

Rappold, Leah C.; Denk, K; Enk, Alexander; Hadaschik, Eva

doi:10.1111/jdv.13496

Cited by 6 publications

(6 citation statements)

References 8 publications

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“…The most common AEs reported in our study, independent of product concentration, are in agreement with the results published in the other studies with IVIG (Colovic et al 2003;Pierce and Jain 2003;Roifman et al 2003;Bussel et al 2004;Robak et al 2009) in which IVIG therapy was shown to be normally safe and well tolerated. The type, seriousness, and severity of AEs registered in our study showed similar patterns between product presentations, which has previously been observed (Kuitwaard et al 2010;Rappold et al 2016). Globally, AEs were consistent with those presented by the patients in previous clinical trials or in normal clinical practice (Orbach et al 2005).…”

Section: Discussionsupporting

confidence: 89%

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Surveillance study on the tolerability and safety of Flebogamma^®DIF (10% and 5% intravenous immunoglobulin) in adult and pediatric patients

Alsina

Mohr²,

Montañés

et al. 2017

Pharmacology Res & Perspec

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Direct comparisons of tolerability and safety of concentrated intravenous immunoglobulin (IVIG) versus less concentrated products are scarce. In this postauthorization, prospective, observational, multicenter study, a systematic comparison of 10% and 5% concentrations of Flebogamma® DIF IVIG was performed in both adult and pediatric patients treated with the studied IVIG products according to the approved indications under routine conditions. Dose of product administered, adverse events (AEs), physical assessments, laboratory tests, and concomitant therapy were analyzed. Patient recruitment in the 10% and 5% product groups was, respectively, 34 (32 analyzed, 13 of them children, receiving 130 IVIG infusions) and 35 (34 analyzed, receiving 135 IVIG infusions). Twenty‐four infusions (18.5%; 95% CI: 11.8, 25.1) with the 10% product and 3 (2.2%; 95% CI: −0.3, 4.7) with the 5% product were associated with potentially treatment‐related AEs (P < 0.0001). Nine patients (28.1%) infused with the 10% product and 3 (8.8%) infused with the 5% product presented, respectively, 33 and 8 treatment‐related AEs (of which 7 and 6, respectively, were serious AEs, experienced by only three hypersensitive patients). The profile of AEs occurring with the infusion of 10% and 5% products were comparable. The most frequent treatment‐related AEs were headache (n = 17, 3 patients; 15 episodes, 1 patient) and pyrexia (n = 6, 4 patients). In conclusion, no unpredictable risk was detected for both Flebogamma DIF 10% and 5% concentrations, which were therefore deemed as safe and well‐tolerated IVIG in the studied population. The frequency of infusions associated with treatment‐related AEs was lower with the 5% concentration.

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Section: Discussionsupporting

confidence: 89%

“…; Rappold et al. ). Globally, AEs were consistent with those presented by the patients in previous clinical trials or in normal clinical practice (Orbach et al.…”

Section: Discussionmentioning

confidence: 98%

Surveillance study on the tolerability and safety of Flebogamma^®DIF (10% and 5% intravenous immunoglobulin) in adult and pediatric patients

Alsina

Mohr²,

Montañés

et al. 2017

Pharmacology Res & Perspec

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“…Among patients receiving immunomodulatory doses of IVIG (2 g/kg), those with a history of headaches are at higher risk for IVIG-induced headaches and/or aseptic meningitis. Typically headaches will develop within six hours of infusion but may start as late as 72 hours after the infusion (Rappold et al 2015;Cherin et al 2016). Headaches typically last 3-7 days in patients with PANS (authors' experience).…”

mentioning

confidence: 99%

Clinical Management of Pediatric Acute-Onset Neuropsychiatric Syndrome: Part II—Use of Immunomodulatory Therapies

FrankovichJennifer

SwedoSusan

MurphyTanya

et al. 2017

Journal of Child and Adolescent Psychopharmacology

102

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Introduction: Pediatric Acute-onset Neuropsychiatric Syndrome (PANS) is a clinically heterogeneous disorder with a number of different etiologies and disease mechanisms. Inflammatory and postinfectious autoimmune presentations of PANS occur frequently, with some clinical series documenting immune abnormalities in 75%-80% of patients. Thus, comprehensive treatment protocols must include immunological interventions, but their use should be reserved only for PANS cases in which the symptoms represent underlying neuroinflammation or postinfectious autoimmunity, as seen in the PANDAS subgroup (Pediatric Autoimmune Neuropsychiatric Disorders associated with Streptococcal infections). Methods: The PANS Research Consortium (PRC) immunomodulatory task force is comprised of immunologists, rheumatologists, neurologists, infectious disease experts, general pediatricians, psychiatrists, nurse practitioners, and basic scientists with expertise in neuroimmunology and PANS-related animal models. Preliminary treatment guidelines were created in the Spring of 2014 at the National Institute of Health and refined over the ensuing 2 years over conference calls and a shared webbased document. Seven pediatric mental health practitioners, with expertise in diagnosing and monitoring patients with

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“…primary immunodeficiency, and vesiculobullous autoimmune diseases. [14][15][16][17][18][19] Previous small studies on KD have also shown no significant difference in the proportion with CAAs between 5% and 10% IVIG for patients with acute-phase KD. 2,4 In this study, 10% IVIG was shown to increase the proportion of IVIG resistance in patients with acute KD.…”

Section: Discussionmentioning

confidence: 92%

“…Numerous studies have shown insignificant differences in outcomes between 5% and 10% IVIG for multifocal motor neuropathy, chronic inflammatory demyelinating polyradiculoneuropathy, primary immunodeficiency, and vesiculobullous autoimmune diseases 14‐19 . Previous small studies on KD have also shown no significant difference in the proportion with CAAs between 5% and 10% IVIG for patients with acute‐phase KD 2,4 …”

Section: Discussionmentioning

confidence: 99%

Low‐ versus high‐concentration intravenous immunoglobulin for children with Kawasaki disease in the acute phase

et al. 2022

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Purpose: Few studies have compared the effects of low-concentration (5%) and high-concentration (10%) intravenous immunoglobulin (IVIG) preparations for patients with Kawasaki disease (KD) in the acute phase. The purpose of this study was to compare outcomes between low-and high-concentration IVIG preparations in children with KD, using a national inpatient database in Japan.Method: We used the Diagnostic Procedure Combination database to identify patients with KD treated with IVIG from April 2012 to March 2020. We identi ed those receiving high-and low-concentration IVIG preparations as an initial treatment. The outcomes included the proportions of patients with coronary artery abnormalities (CAAs) and IVIG resistance, length of stay, and medical costs. Propensity scorematched analyses were conducted to compare the outcomes between the two groups. Instrumental variable analyses were performed to con rm the results.Result: We identi ed 48,046 patients with KD and created 4:1 propensity score-matched pairs between the low-and high-concentration IVIG groups. There was a signi cant difference in the percentage with IVIG resistance between the two groups (20.6% vs 24.1%; risk difference, 3.5% [95% con dence interval, 2.3-4.7]; p < 0.001). However, there was no signi cant difference in CAAs (1.6% vs 1.6%; risk difference, 0.013% [95% con dence interval, −0.34 to 0.37]; p = 0.953). The instrumental variable analyses showed similar results.Conclusions: The proportion of CAAs did not differ signi cantly between those receiving low-and highconcentration IVIG. To con rm the results of this study, prospective studies adjusting for duration of IVIG administration and duration of observation are needed. BackgroundWhat is Known:-For treatments of Kawasaki Disease in acute phase, intravenous immunoglobulin (IVIG) has been the most recommended to reduce fever early and prevent complications of coronary artery abnormalities. There are two types of IVIG preparations, low-concentration (5%) IVIG and high-concentration (10%) IVIG. However, few studies have performed comparisons to determine which preparation of IVIG is superior.What is New:-The present ndings suggest that the proportion of coronary artery abnormalities did not differ signi cantly between those receiving low-and high-concentration IVIG.

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Comparison of high‐dose intravenous immunoglobulin (IVIG) in a 5% and a 10% solution does not reveal a significantly different spectrum of side‐effects

Cited by 6 publications

References 8 publications

Surveillance study on the tolerability and safety of Flebogamma^®DIF (10% and 5% intravenous immunoglobulin) in adult and pediatric patients

Surveillance study on the tolerability and safety of Flebogamma^®DIF (10% and 5% intravenous immunoglobulin) in adult and pediatric patients

Clinical Management of Pediatric Acute-Onset Neuropsychiatric Syndrome: Part II—Use of Immunomodulatory Therapies

Low‐ versus high‐concentration intravenous immunoglobulin for children with Kawasaki disease in the acute phase

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Comparison of high‐dose intravenous immunoglobulin (IVIG) in a 5% and a 10% solution does not reveal a significantly different spectrum of side‐effects

Cited by 6 publications

References 8 publications

Surveillance study on the tolerability and safety of Flebogamma®DIF (10% and 5% intravenous immunoglobulin) in adult and pediatric patients

Surveillance study on the tolerability and safety of Flebogamma®DIF (10% and 5% intravenous immunoglobulin) in adult and pediatric patients

Clinical Management of Pediatric Acute-Onset Neuropsychiatric Syndrome: Part II—Use of Immunomodulatory Therapies

Low‐ versus high‐concentration intravenous immunoglobulin for children with Kawasaki disease in the acute phase

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Product

Resources

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Surveillance study on the tolerability and safety of Flebogamma^®DIF (10% and 5% intravenous immunoglobulin) in adult and pediatric patients

Surveillance study on the tolerability and safety of Flebogamma^®DIF (10% and 5% intravenous immunoglobulin) in adult and pediatric patients