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• W1996545201 abstract "RationaleThe IGSC 20% (Hizentra, CSL) package insert recommends dose adjustment to achieve the desired clinical response and serum IgG trough level when patients switch from IGIV therapy to IGSC 20%. The objective of this study is to examine if dose adjustment occurs in patients switching from IGIV to IGSC 20% in real world settings.MethodsPharmacy claims for IG products dispensed to treat Primary Immunodeficiency (PI) were extracted from specialty pharmacy dispensing data from January 2009 - June 2011. Route of administration was identified by prescribed brand and dosing frequency. Patients with ≥2 claims for any IGIV who subsequently switched to IGSC 20% were included in the analysis. Dosing adjustment was calculated for each patient as the ratio of gm/30days of [(IGSC 20%) / (IGIV)]. Wilcoxon signed rank test was used to test the research hypothesis that the dose adjustment ratio was different from 1.ResultsThere were 83 patients who switched from any IGIV to IGSC 20% after applying the inclusion and exclusion criteria. Among them, 81% had a median dose adjustment of 1.41 (mean 1.46) when switching from IGIV to IGSC 20%, which was statistically significant (p<0.0001). The median number of days on IGIV and IGSC 20% therapy in this study was 342 and 163 days respectively. The median 30 day dose was 35.7g for IGIV and 44.2g for IGSC 20%.ConclusionUsing real world pharmacy dispensing data, this study suggests that dose increase occurred when PI patients switched from IGIV therapy to IGSC 20%. RationaleThe IGSC 20% (Hizentra, CSL) package insert recommends dose adjustment to achieve the desired clinical response and serum IgG trough level when patients switch from IGIV therapy to IGSC 20%. The objective of this study is to examine if dose adjustment occurs in patients switching from IGIV to IGSC 20% in real world settings. The IGSC 20% (Hizentra, CSL) package insert recommends dose adjustment to achieve the desired clinical response and serum IgG trough level when patients switch from IGIV therapy to IGSC 20%. The objective of this study is to examine if dose adjustment occurs in patients switching from IGIV to IGSC 20% in real world settings. MethodsPharmacy claims for IG products dispensed to treat Primary Immunodeficiency (PI) were extracted from specialty pharmacy dispensing data from January 2009 - June 2011. Route of administration was identified by prescribed brand and dosing frequency. Patients with ≥2 claims for any IGIV who subsequently switched to IGSC 20% were included in the analysis. Dosing adjustment was calculated for each patient as the ratio of gm/30days of [(IGSC 20%) / (IGIV)]. Wilcoxon signed rank test was used to test the research hypothesis that the dose adjustment ratio was different from 1. Pharmacy claims for IG products dispensed to treat Primary Immunodeficiency (PI) were extracted from specialty pharmacy dispensing data from January 2009 - June 2011. Route of administration was identified by prescribed brand and dosing frequency. Patients with ≥2 claims for any IGIV who subsequently switched to IGSC 20% were included in the analysis. Dosing adjustment was calculated for each patient as the ratio of gm/30days of [(IGSC 20%) / (IGIV)]. Wilcoxon signed rank test was used to test the research hypothesis that the dose adjustment ratio was different from 1. ResultsThere were 83 patients who switched from any IGIV to IGSC 20% after applying the inclusion and exclusion criteria. Among them, 81% had a median dose adjustment of 1.41 (mean 1.46) when switching from IGIV to IGSC 20%, which was statistically significant (p<0.0001). The median number of days on IGIV and IGSC 20% therapy in this study was 342 and 163 days respectively. The median 30 day dose was 35.7g for IGIV and 44.2g for IGSC 20%. There were 83 patients who switched from any IGIV to IGSC 20% after applying the inclusion and exclusion criteria. Among them, 81% had a median dose adjustment of 1.41 (mean 1.46) when switching from IGIV to IGSC 20%, which was statistically significant (p<0.0001). The median number of days on IGIV and IGSC 20% therapy in this study was 342 and 163 days respectively. The median 30 day dose was 35.7g for IGIV and 44.2g for IGSC 20%. ConclusionUsing real world pharmacy dispensing data, this study suggests that dose increase occurred when PI patients switched from IGIV therapy to IGSC 20%. Using real world pharmacy dispensing data, this study suggests that dose increase occurred when PI patients switched from IGIV therapy to IGSC 20%." @default.
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• W1996545201 title "Assessment of Actual Dose Adjustment in Patients Switching From Intravenous Immunoglobulin (IGIV) Therapy to IGSC 20%" @default.
• W1996545201 doi "https://doi.org/10.1016/j.jaci.2011.12.540" @default.
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