Subcutaneous immunoglobulin
replacement in patients with primary antibody deficiencies: safety
and costs.
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.
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.
J Gaspar,
B Gerritsen,
A Jones
Department of Immunology, Great Ormond Street
Hospital for Children NHS Trust, London WC1N 3JH, UK
Correspondence to: J Gaspar or A Jones.
Accepted 7 January 1998
Long term intravenous immunoglobulin (IVIG)
infusion is an effective treatment for children with
immunodeficiencies, but can
be complicated by poor venous access, systemic adverse
reactions, and the need for frequent hospital admission.
Rapid subcutaneous immunoglobulin (SCIG) infusion has
been found to be effective in adults with primary
immunodeficiency. Twenty six children were treated with
SCIG for a median period of two years (range six months
to 3.5 years). Fifteen children had previously been treated
with IVIG. Retrospective analysis showed that trough IgG
concentrations while receiving SCIG were comparable with
those while receiving IVIG during maintenance treatment.
In severe hypogammaglobulinaemia, however, initial
loading with SCIG or IVIG is probably indicated. During
the treatment period there was no systemic adverse reaction
nor severe reaction requiring admission to hospital. The
subjective impression of all families was a significant
improvement in the quality of life. This preliminary
experience with SCIG in children suggests that it is an
effective, convenient, and well tolerated alternative to
intravenous treatment. Larger prospective studies are
required to determine the place of SCIG in the management
of immunodeficiencies.
Keywords: immunoglobulin; subcutaneous infusion;
immunodeficiency