Subcutaneous Hizentra® (20%) Is Better Tolerated And Shares Similar Efficacy Compared To Subcutaneous Vivaglobin® (16%)

Nguyen, D.; Dorsey, Morna J.; Alberdi, T. K.; Duff, Carla; Sleasman, J.W.

doi:10.1016/j.jaci.2011.12.917

Cited by 3 publications

(4 citation statements)

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“…The mean change in serum IgG concentrations on Hizentra®, relative to the previous SCIG products was −20 mg/dL (95 % CI: −49 mg/dL to +90 mg/dL). In the US study [16], 19 patients on a mean weekly dose of 150 ± 60 mg/kg of Vivaglobin® were switched to Hizentra® at a mean weekly dose of 155 ± 60 mg/kg. The 4 % increase in dose on Hizentra® was due to rounding in a few cases.…”

Section: Resultsmentioning

confidence: 99%

“…The mean serum IgG levels were calculated by averaging individual patient’s median values at each time period. In the US study [16], 19 patients receiving steady-state Vivaglobin® treatment were switched to an equal weekly dose of Hizentra®. Due to dose rounding in several cases, the mean (±SD) dose of Hizentra® was 1.04 times higher than that of Vivaglobin®: 155 ± 60 mg/kg/week vs. 150 ± 60 mg/kg/week.…”

Section: Methodsmentioning

confidence: 99%

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Bioavailability of IgG Administered by the Subcutaneous Route

et al. 2013

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PurposeUS licensing studies of subcutaneous IgG (SCIG) calculate dose adjustments necessary to achieve area under the curve (AUC) of serum IgG vs. time on SCIG that is non-inferior to that on intravenous IgG (IVIG), within the FDA-set limit of ±20 %. The results are interpreted as showing that different SCIGs differ in bioavailability. We used three approaches to determine if the bioavailabilities were actually different.MethodsDose adjustments and AUCs from published licensing studies were used to calculate bioavailabilities using the formula: Bioavailability (% of IVIG) = AUC(SCIG) ÷ AUC(IVIG) x 1/Dose Adjustment. We also compared the increment in serum IgG concentration achieved with varying doses of SCIG in recent meta-analyses with the increment with different doses of IVIG, and determined the serum IgG concentrations when patients switched SCIG products at the same dose.ResultsThe actual bioavailabilities were: Gamunex® 65.0 %, Hizentra® 65.5 %, Gammagard® 67.2 %, Vivaglobin® 69.0 %. Regression analyses of serum IgG vs. dose showed that the mean increase in serum IgG resulting from a 100 mg/kg/month increment in SCIG dosing was 69.4 % of the increase with the same increment in IVIG dosing (84 mg/dL vs. 121 mg/dL). Patients switching SCIG preparations at the same dose had no change in serum IgG levels, confirming that bioavailabilities of the SCIG preparations did not differ.ConclusionsDecreased bioavailability appears to be a basic property of SCIG and not a result of any manufacturing process or concentration. Because serum IgG levels do not vary with different SCIG products at the same dose, adjustments are not necessary when switching products.

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Section: Resultsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Bioavailability of IgG Administered by the Subcutaneous Route

et al. 2013

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“…In the EU study [15] [16][17][18][19][20][21][22][23][24], and for the postefficacy period (Weeks 30-36), to be sure that a steady state was achieved. The mean serum IgG levels were calculated by averaging individual patient's median values at each time period.…”

Section: Methodsmentioning

confidence: 99%

“…The mean serum IgG levels were calculated by averaging individual patient's median values at each time period. In the US study [16], 19 patients receiving steadystate Vivaglobin® treatment were switched to an equal weekly dose of Hizentra®. Due to dose rounding in several cases, the mean (±SD) dose of Hizentra® was 1.04 times higher than that of Vivaglobin®: 155±60 mg/kg/week vs. 150±60 mg/kg/week.…”

Section: Methodsmentioning

confidence: 99%

Bioavailability of IgG Administered by the Subcutaneous Route

Berger¹,

Jolles²,

Sleasman³

2012

Journal of Allergy and Clinical Immunology

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Purpose US licensing studies of subcutaneous IgG (SCIG) calculate dose adjustments necessary to achieve area under the curve (AUC) of serum IgG vs. time on SCIG that is noninferior to that on intravenous IgG (IVIG), within the FDAset limit of ±20 %. The results are interpreted as showing that different SCIGs differ in bioavailability. We used three approaches to determine if the bioavailabilities were actually different. Methods Dose adjustments and AUCs from published licensing studies were used to calculate bioavailabilities using the formula: Bioavailability (% of IVIG) = AUC(SCIG) ÷ AUC(IVIG) x 1/Dose Adjustment. We also compared the increment in serum IgG concentration achieved with varying doses of SCIG in recent meta-analyses with the increment with different doses of IVIG, and determined the serum IgG concentrations when patients switched SCIG products at the same dose. Results The actual bioavailabilities were: Gamunex® 65.0 %, Hizentra® 65.5 %, Gammagard® 67.2 %, Vivaglobin® 69.0 %. Regression analyses of serum IgG vs. dose showed that the mean increase in serum IgG resulting from a 100 mg/kg/month increment in SCIG dosing was 69.4 % of the increase with the same increment in IVIG dosing (84 mg/dL vs. 121 mg/dL). Patients switching SCIG preparations at the same dose had no change in serum IgG levels, confirming that bioavailabilities of the SCIG preparations did not differ.Conclusions Decreased bioavailability appears to be a basic property of SCIG and not a result of any manufacturing process or concentration. Because serum IgG levels do not vary with different SCIG products at the same dose, adjustments are not necessary when switching products.

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20% subcutaneous immunoglobulin for patients with primary immunodeficiency diseases: A systematic review

Song

Zhang

et al. 2015

International Immunopharmacology

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Subcutaneous Hizentra® (20%) Is Better Tolerated And Shares Similar Efficacy Compared To Subcutaneous Vivaglobin® (16%)

Cited by 3 publications

References 0 publications

Bioavailability of IgG Administered by the Subcutaneous Route

Bioavailability of IgG Administered by the Subcutaneous Route

Bioavailability of IgG Administered by the Subcutaneous Route

20% subcutaneous immunoglobulin for patients with primary immunodeficiency diseases: A systematic review

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