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Privigen® has similar pharmacokinetic properties in primary and secondary immune deficiency.

Abstract：

PURPOSE:Primary (PID) and secondary immune deficiencies (SID) represent diverse groups of diagnoses, yet both can be effectively treated with intravenous immunoglobulin (IVIG) replacement therapy. Guidelines for the use of IVIG in SID vary due to the paucity of data. The objective was to analyze available IVIG Privigen® (IgPro10, CSL Behring, Bern, Switzerland) data on Efficiency Index (EI) and pharmacokinetic (PK) parameters in patients with PID and SID. METHODS:Three Privigen® studies (NCT00168025, NCT00322556, and the observational study IgPro10_5001) were used to identify patients with PID and SID meeting the qualifying criteria for the PK analysis. PK properties of IVIG were estimated using a population PK model based on a standard two-compartment PK model. Immunoglobulin G (IgG) EI was calculated as the gain in serum IgG level per unit external IgG dose. RESULTS:A similar IVIG dose-serum IgG concentration relationship was observed in patients with PID (N = 90) and SID (N = 91). IgG EI was inversely proportional to the endogenous IgG concentration and comparable in PID (slope = -1.079) and SID (slope = -2.12). CONCLUSIONS:These findings indicate that the disposition of Privigen® is similar during IgG replacement therapy in PID and SID. The results contribute to the understanding of IVIG treatment of SID and may support an evidence-based approach for the use of IVIG in SID in the future.

journal_name

Int Immunopharmacol

journal_title

International immunopharmacology

authors

Tortorici MA,Lawo JP,Weide R,Jochems J,Puli S,Hofmann J,Pfruender D,Rojavin MA

doi

10.1016/j.intimp.2018.11.008

subject

Has Abstract

pub_date

2019-01-01 00:00:00

pages

119-126

eissn

1567-5769

issn

1878-1705

pii

S1567-5769(18)30740-9

journal_volume

66

pub_type

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