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Efficacy and safety of subcutaneous vivaglobin® replacement therapy in previously untreated patients with primary immunodeficiency: a prospective, multicenter study.

Abstract：

:Treatment of primary immunodeficiency (PI) is typically initiated with intravenous immunoglobulin (IVIG) loading and then continued with IVIG or subcutaneous IgG (SCIG). This prospective, open-label, multicenter, 6-month study evaluated a new regimen of initiating IgG therapy with SCIG in 18 previously untreated patients. In the loading phase, SCIG 100 mg/kg was administered for five consecutive days (total loading dose 500 mg/kg). During the maintenance phase, patients self-infused SCIG 100 mg/kg/week at home. The primary efficacy endpoint of IgG levels ≥5 g/L on day 12 was achieved in 17 patients (94.4%; 95% CI 0.727, 0.999). The rate of infections was 3.95 episodes/patient/year. Improvement was found in many subscales of the health-related quality of life questionnaires. SCIG treatment was well tolerated, with no related serious adverse events (AEs). Nine (50%) patients experienced related AEs, including local reactions (rate 0.105 events/infusion). The results suggest that therapy of newly diagnosed patients with PI can be initiated directly with SCIG.

journal_name

J Clin Immunol

journal_title

Journal of clinical immunology

authors

Borte M,Quinti I,Soresina A,Fernández-Cruz E,Ritchie B,Schmidt DS,McCusker C

doi

10.1007/s10875-011-9588-5

subject

Has Abstract

pub_date

2011-12-01 00:00:00

pages

952-61

issue

6

eissn

0271-9142

issn

1573-2592

journal_volume

31

pub_type

临床试验,杂志文章,多中心研究

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