Document 0339
 DOCN  M9550339
 TI    Subcutaneous immunoglobulin replacement in patients with primary
       antibody deficiencies: safety and costs.
 DT    9505
 AU    Gardulf A; Andersen V; Bjorkander J; Ericson D; Froland SS; Gustafson R;
       Hammarstrom L; Jacobsen MB; Jonsson E; Moller G; et al; Department of
       Clinical Immunology, Karolinska Institute, Huddinge; University
       Hospital, Sweden.
 SO    Lancet. 1995 Feb 11;345(8946):365-9. Unique Identifier : AIDSLINE
       MED/95147593
 AB    Immunoglobulins (IgG) as replacement therapy in primary antibody
       deficiencies can be given as intramuscular injections, or as intravenous
       or subcutaneous infusions. Our aims were to obtain information on the
       frequency of adverse systemic reactions during subcutaneous therapy, the
       occurrence and intensity of tissue reactions at the infusion sites, and
       serum IgG changes. Furthermore, we compared costs between the different
       replacement regimes. Our study included 165 patients (69 women, 96 men,
       aged 13-76 years) with primary hypogammaglobulinaemia or IgG-subclass
       deficiencies. Data were compiled from questionnaires filled in by the
       patients and from their medical records. 33,168 subcutaneous infusions
       (27,030 in home therapy) had been given. 106 (of which 16 were at home)
       adverse systemic reactions (100 mild, 6 moderate) were recorded in 28
       patients (17%). No severe or anaphylactoid reactions occurred. Despite
       large immunoglobulin volumes given during 434 patient years (28,480
       infusions), no signs have been found that indicate the transmission of
       hepatitis virus. Transient tissue reactions occurred at the infusion
       sites but were not troublesome to most patients and we found significant
       increases in mean serum IgG. The use of subcutaneous instead of
       intravenous infusions at home would reduce the yearly cost per patient
       for the health-care sector by US $10,100 in Sweden alone. We conclude
       that subcutaneous administration of IgG is a safe and convenient method
       of providing immunoglobulins. We were able to reach serum IgG
       concentrations similar to those by the intravenous therapy and we found
       that the method could also be used successfully in patients with
       previous severe or anaphylactoid reactions to intramuscular injections.
 DE    Adolescence  Adult  Agammaglobulinemia/THERAPY  Aged  Common Variable
       Immunodeficiency/THERAPY  Comparative Study  Costs and Cost Analysis
       Female  Home Care Services  Hospitalization  Human  IgG/BLOOD
       Immunoglobulins/*ADMINISTRATION & DOSAGE/ADVERSE EFFECTS/
       ECONOMICS/THERAPEUTIC USE  Immunologic Deficiency Syndromes/*THERAPY
       Injections, Subcutaneous/ADVERSE EFFECTS  Male  Middle Age  Support,
       Non-U.S. Gov't  CLINICAL TRIAL  JOURNAL ARTICLE  MULTICENTER STUDY

       SOURCE: National Library of Medicine.  NOTICE: This material may be
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