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Efficacy, safety and pharmacokinetics of a novel subcutaneous immunoglobulin, Evogam®, in primary immunodeficiency.

Abstract：

:This phase III, open-label, multi-centre study investigated the efficacy, safety, pharmacokinetics and quality of life impact of Evogam(®), a new chromatographically fractionated 16% subcutaneous immunoglobulin, utilising a 1:1 dose transition ratio from previous immunoglobulin therapy. Thirty-five previously treated patients with primary immunodeficiency received weekly Evogam over 36 weeks. Primary endpoints were rate of serious bacterial infections (SBIs) and steady-state serum immunoglobulin G (IgG) trough concentrations. No SBIs were reported during the study. Evogam produced significantly higher mean trough IgG concentrations with 1:1 dose conversion compared to previous immunoglobulin treatment (8.94 versus 8.27 g/L, p = 0.0063). Evogam was efficacious in the prevention of infections and maintenance of trough levels using a 1:1 dose conversion. It was well tolerated with no withdrawals due to adverse events and was preferred to IVIg by the majority of patients.

journal_name

J Clin Immunol

journal_title

Journal of clinical immunology

authors

Empson MB,Tang ML,Pearce LK,Rozen L,Gold MS,Katelaris CH,Langton D,Smart J,Smith WB,Steele RH,Ziegler JB,Maher D

doi

10.1007/s10875-011-9641-4

subject

Has Abstract

pub_date

2012-10-01 00:00:00

pages

897-906

issue

5

eissn

0271-9142

issn

1573-2592

journal_volume

32

pub_type

杂志文章,多中心研究

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