A. Gardulf et al., SUBCUTANEOUS IMMUNOGLOBULIN REPLACEMENT IN PATIENTS WITH PRIMARY ANTIBODY DEFICIENCIES - SAFETY AND COSTS, Lancet, 345(8946), 1995, pp. 365-369
Immunoglobulins (IgG) as replacement therapy in primary antibody defic
iencies can be given as intramuscular injections, or as intravenous or
subcutaneous infusions. Our aims were to obtain information on the fr
equency of adverse systemic reactions during subcutaneous therapy, the
occurrence and intensity of tissue reactions at the infusion sites, a
nd serum IgG changes. Furthermore, we compared costs between the diffe
rent replacement regimes. Our study included 165 patients (69 women, 9
6 men, aged 13-76 years) with primary hypogammaglobulinaemia or IgG-su
bclass deficiencies. Data were compiled from questionnaires filled in
by the patients and from their medical records. 33168 subcutaneous inf
usions (27 030 in home therapy) had been given, 106 (of which 16 were
at home) adverse systemic reactions (100 mild, 6 moderate) were record
ed 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 transmi
ssion of hepatitis virus. Transient tissue reactions occurred at the i
nfusion sites but were not troublesome to most patients and we found s
ignificant increases in mean serum IgG. The use of subcutaneous instea
d of intravenous infusions at home would reduce the yearly cost per pa
tient for the health-care sector by US $10 100 in Sweden alone. We con
clude 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 foun
d that the method could also be used successfully in patients with pre
vious severe or anaphylactoid reactions to intramuscular injections, L
ancet1995;345:365-69