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

Wasserman, Richard L.; Melamed, Isaac; Stein, Mark R.; Jolles, Stephen; Norton, Miranda; Moy, James N.

doi:10.1007/s10875-017-0383-9

Cited by 13 publications

(10 citation statements)

References 14 publications

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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: 93%

“…Numerous studies have shown insigni cant differences in outcomes between 5% and 10% IVIG for multifocal motor neuropathy, chronic in ammatory demyelinating polyradiculoneuropathy, primary immunode ciency, and vesiculobullous autoimmune diseases. [14][15][16][17][18][19] Previous small studies on KD have also shown no signi cant 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: 99%

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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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Section: Discussionmentioning

confidence: 93%

Section: Discussionmentioning

confidence: 99%

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

et al. 2022

View full text Add to dashboard Cite

show abstract

Section: Discussionmentioning

confidence: 99%

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

Suzuki¹,

Michihata²,

Yoshikawa³

et al. 2021

Preprint

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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 identified 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 score-matched analyses were conducted to compare the outcomes between the two groups. Instrumental variable analyses were performed to confirm the results.Result: We identified 48,046 patients with KD and created 4:1 propensity score-matched pairs between the low- and high-concentration IVIG groups. There was a significant difference in the percentage with IVIG resistance between the two groups (20.6% vs 24.1%; risk difference, 3.5% [95% confidence interval, 2.3-4.7]; p < 0.001). However, there was no significant difference in CAAs (1.6% vs 1.6%; risk difference, 0.013% [95% confidence interval, −0.34 to 0.37]; p = 0.953). The instrumental variable analyses showed similar results.Conclusions: The proportion of CAAs did not differ significantly between those receiving low- and high-concentration IVIG. To confirm the results of this study, prospective studies adjusting for duration of IVIG administration and duration of observation are needed.

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“…Clinical investigation studies often use serial blood sampling as a means for understanding PK properties in accordance with regulatory guidance. These studies commonly characterize serum IgG PK profiles through the serial evaluation of serum IgG levels during one or more dosing intervals [12][13][14][15]. While serial sampling generally facilitates the provision of valuable PK data, this practice has some drawbacks, including added logistical challenges for the conduct of clinical trials, as well as the burden of multiple blood draws for patients, particularly for pediatric patients, for whom venipuncture can be a highly distressing experience [16].…”

Section: Introductionmentioning

confidence: 99%

Steady-State Serum IgG Trough Levels Are Adequate for Pharmacokinetic Assessment in Patients with Immunodeficiencies Receiving Subcutaneous Immune Globulin

McCoy

Engl

et al. 2021

J Clin Immunol

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Patients with primary immunodeficiency diseases often require lifelong immunoglobulin (IG) therapy. Most clinical trials investigating IG therapies characterize serum immunoglobulin G (IgG) pharmacokinetic (PK) profiles by serially assessing serum IgG levels. This retrospective analysis evaluated whether steady-state serum IgG trough level measurement alone is adequate for PK assessment. Based on individual patient serum IgG trough levels from two pivotal trials (phase 2/3 European [NCT01412385] and North American [NCT01218438]) of weekly 20% subcutaneous IG (SCIG; Cuvitru, Ig20Gly), trough level-predicted IgG AUC (AUCτ,tp) were calculated and compared with the reported AUC calculated from serum IgG concentration-time profiles (AUCτ). In both studies, mean AUCτ,tp values for Ig20Gly were essentially equivalent to AUCτ with point estimates of geometric mean ratio (GMR) of AUCτ,tp/AUCτ near 1.0 and 90% CIs within 0.80–1.25. In contrast, for IVIG, 10%, mean AUCτ,tp values were lower than AUCτ by >20%, (GMR [90% CI]: 0.74 [0.70–0.78] and 0.77 [0.73–0.81] for the two studies, respectively). Mean AUCτ,tp values calculated for 4 other SCIG products (based on mean IgG trough levels reported in the literature/labels) were also essentially equivalent to the reported AUCτ (differences <10% for all except HyQvia, a facilitated SCIG product), while differences for IVIG products were >20%. In conclusion, steady-state serum IgG levels following weekly SCIG remain stable, allowing for reliable prediction of AUC over the dosing interval using trough IgG levels. These findings indicate that measuring steady-state serum IgG trough levels alone may be adequate for PK assessment of weekly SCIG.

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

Cited by 13 publications

References 14 publications

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

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

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

Steady-State Serum IgG Trough Levels Are Adequate for Pharmacokinetic Assessment in Patients with Immunodeficiencies Receiving Subcutaneous Immune Globulin

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