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European Journal of Medical Research
Published in: European Journal of Medical Research 6/2010

01-12-2010 | Research

Home-based subcutaneous immunoglobulin G replacement therapy under real-life conditions in children and adults with antibody deficiency

Authors: F Hoffmann, B Grimbacher, J Thiel, HH Peter, BH Belohradsky, Vivaglobin® Study Group

Published in: European Journal of Medical Research | Issue 6/2010

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Abstract

Background

Subcutaneous immunoglobulin (SCIG) therapy is an alternative to intravenous immunoglobulin (IVIG) therapy.

Methods

We evaluated the efficacy and safety of the SCIG Vivaglobin® (formerly known as Beriglobin® SC) under real-life conditions in a post-marketing observational study in 82 patients with primary or secondary antibody deficiencies. Health-related quality of life (HRQoL) was evaluated in a subset of 30 patients previously treated with IVIG (including 11 children < 14 years) using the Short Form 36 (SF-36) for patients ≥ 14 years of age (adults) and the Child Health Questionnaire - Parental Form 50 (CHQ-PF50) for children < 14 years of age. Treatment preferences were assessed in adults.

Results

The mean serum immunoglobulin G (IgG) trough level during SCIG treatment (7.5 g/L) was higher than during previous IVIG treatment (6.6 g/L; p < 0.01). The investigators assessed the efficacy of SCIG therapy as "excellent" in 89% of patients. No systemic adverse drug reactions were observed. Improvements by ≥ 5 points were observed in 5 of 8 SF36 subscales and in 6 of 12 CHQ-PF50 subscales. Statistically significant improvements (p ≤ 0.05) were observed for the SF-36 subscales of bodily pain, general health perceptions, and vitality (adults), and for the CHQ-PF50 subscales of general health perceptions, parental impact - time, parental impact - emotional, and family activities (children). Patients preferred SCIG over IVIG therapy (92%) and home therapy over therapy at the clinic/physician (83%).

Conclusion

This study confirms that therapy with Vivaglobin® at home is effective, safe, well tolerated, and improves quality of life in patients with antibody deficiency.
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Metadata
Title
Home-based subcutaneous immunoglobulin G replacement therapy under real-life conditions in children and adults with antibody deficiency
Authors
F Hoffmann
B Grimbacher
J Thiel
HH Peter
BH Belohradsky
Vivaglobin® Study Group
Publication date
01-12-2010
Publisher
BioMed Central
Published in
European Journal of Medical Research / Issue 6/2010
Electronic ISSN: 2047-783X
DOI
https://doi.org/10.1186/2047-783X-15-6-238

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