title: Home-based subcutaneous immunoglobulin G replacement therapy under real-life conditions in children and adults with antibody deficiency.
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%).
  
  
  CONCLUSIONS
  This study confirms that therapy with Vivaglobin at home is effective, safe, well tolerated, and improves quality of life in patients with antibody deficiency.
authors.affiliation: University Children's Hospital, Paediatric Infectious Diseases and Immunology, Ludwig Maximilians University, Munich, Germany. Florian.Hoffmann@med.uni-muenchen.de
authors.forename: F
authors.initials: F
authors.lastname: Hoffmann
authors.forename: B
authors.initials: B
authors.lastname: Grimbacher
authors.forename: J
authors.initials: J
authors.lastname: Thiel
authors.forename: H-H
authors.initials: HH
authors.lastname: Peter
authors.forename: B H
authors.initials: BH
authors.lastname: Belohradsky
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002648:Child; D002675:Child, Preschool; D005260:Female; D006304:Health Status; D006801:Humans; D007136:Immunoglobulins / Q000008:administration & dosage* / Q000097:blood; D007153:Immunologic Deficiency Syndromes / Q000276:immunology / Q000503:physiopathology / Q000628:therapy*; D007167:Immunotherapy / Q000379:methods; D007223:Infant; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing; D011446:Prospective Studies; D011788:Quality of Life; D012720:Severity of Illness Index; D055815:Young Adult
chemical_list: D007136:Immunoglobulins; C510539:Vivaglobin