Secondary
hypogammaglobulinemia is one of the factors responsible for the increased susceptibility to
infection in patients with
chronic lymphocytic leukemia (CLL). This study assessed the therapeutic results, concomitant medication and tolerance of administering 5%
intravenous immunoglobulin, secondary immunodeficiency and recurrent serious
bacterial infections. A single center, post-marketing, observational clinical study was performed on 10 patients with a variety of
hematological malignancies (CLL, follicular
non-Hodgkin lymphoma,
IgM-secreting immunocytoma,
IgA plasmacytoma and
myelodysplastic syndrome/
non-Hodgkin lymphoma) who had been infused with
IVIG from June 1994 to May 2009. The clinical benefit of
IVIG was assessed by comparing the incidence of
bacterial infections before and after starting this
therapy. Plasma
immunoglobulin concentrations and relevant hematological variables were recorded. For safety assessment, adverse events were monitored. The standard
IVIG dosage was approximately 0.35 g/kg
body weight every 3-4 weeks. Most patients had normal
IgG trough values of >600 mg/dL during the
IVIG treatment period. The rate of
bacterial infections was reduced from 2.4 per patient in the 3 months before
IVIG to 0.7 (0-1.5) per patient per year during
IVIG treatment. All patients received concomitant medication, mainly anticancer and anti-
anemia therapy (100%). No serious adverse events related to
IVIG were observed. The frequency of at least one minor adverse reaction was 1.44% (8/556 infusions). In conclusion, the investigated
IVIG preparation was well tolerated and clinically beneficial in reducing the long term rate of serious
bacterial infections in patients receiving concomitant treatment for malignant diseases.