Repeated administration of recombinant human serum albumin caused no serious allergic reactions in patients with liver cirrhosis: a multicenter clinical study.
BACKGROUND
We carried out a multicenter study to evaluate the safety of recombinant human serum albumin (rHSA), developed using the methylotrophic yeast Pichia pastoris, during and after repeated administration in patients with liver cirrhosis.


METHODS
rHSA was administered to 423 cirrhosis patients with ascites or edema. rHSA was administered three times over 3 days, and each 3-day treatment course was repeated at least three times with an interval of at least 2 weeks between courses. Adverse drug reactions (ADRs) were monitored during and after repeated rHSA administration. Specific antibody titers against Pichia yeast components were measured before and after treatment. Efficacy was evaluated on the basis of changes in serum albumin level, colloid osmotic pressure, and body weight.


RESULTS
ADRs were observed in 96 of 423 patients (22.7%), with no serious allergy or difference in the incidence of ADRs observed among the first, second, and third administrations. Specific IgE and IgG antibodies were detected before treatment in 19 and 422 patients, respectively. However, allergic ADRs were observed in 14 patients in whom specific IgE antibodies were not detected. No obvious relationship between allergic ADRs and specific IgE or IgG titers was identified. Serum albumin levels and colloid osmotic pressure increased significantly (P < 0.0001), and body weight decreased significantly (P < 0.0001) after rHSA administration.


CONCLUSIONS
rHSA caused no serious allergic reactions even when three treatment courses were administered at intervals of at least 2 weeks.
Kasahara
Akinori
A
Department of General Medicine, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita 565-0871, Japan.
Kita
Keiji
K
Tomita
Eiichi
E
Toyota
Jouji
J
Imai
Yasuharu
Y
Kumada
Hiromitsu
H
D000328:Adult; D000368:Aged; D005260:Female; D005656:Fungal Proteins / Q000276:immunology; D006801:Humans; D006967:Hypersensitivity / Q000175:diagnosis / Q000209:etiology*; D007073:Immunoglobulin E / Q000097:blood; D007074:Immunoglobulin G / Q000097:blood; D008103:Liver Cirrhosis / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D010843:Pichia / Q000276:immunology; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects / Q000096:biosynthesis; D012709:Serum Albumin / Q000008:administration & dosage* / Q000009:adverse effects / Q000096:biosynthesis
D005656:Fungal Proteins; D007074:Immunoglobulin G; D011994:Recombinant Proteins; D012709:Serum Albumin; D007073:Immunoglobulin E