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Hoffmann, F; Grimbacher, B; Thiel, J; Peter, HH; Belohradsky, BH, , Vivaglobin, Study, Group.
Home-based subcutaneous immunoglobulin G replacement therapy under real-life conditions in children and adults with antibody deficiency.
EUR J MED RES. 2010; 15(6): 238-45.
Doi: 10.1186/2047-783x-15-6-238
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- Co-authors Med Uni Graz
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Thiel Jens
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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 > or = 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 > or = 5 points were observed in 5 of 8 SF-36 subscales and in 6 of 12 CHQ-PF50 subscales. Statistically significant improvements (p< or =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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Adolescent - administration & dosage
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Adult - administration & dosage
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Aged - administration & dosage
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Child - administration & dosage
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Child, Preschool - administration & dosage
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Female - administration & dosage
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Health Status - administration & dosage
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Humans - administration & dosage
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Immunoglobulins - administration & dosage, blood
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Immunologic Deficiency Syndromes - immunology, physiopathology, therapy
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Immunotherapy - methods
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Infant - administration & dosage
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Injections, Subcutaneous - administration & dosage
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Male - administration & dosage
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Middle Aged - administration & dosage
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Product Surveillance, Postmarketing - administration & dosage
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Prospective Studies - administration & dosage
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Quality of Life - administration & dosage
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Severity of Illness Index - administration & dosage
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Young Adult - administration & dosage
- Find related publications in this database (Keywords)
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antibody deficiency
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subcutaneous immunoglobulin therapy
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quality of life
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children
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adults