Prospective open-label study of pharmacokinetics, efficacy and safety of a new 10% liquid intravenous immunoglobulin in patients with hypo- or agammaglobulinemia.
OBJECTIVE
The aim of this study was to evaluate the pharmacokinetics, efficacy and safety of a newly developed 10% liquid immunoglobulin preparation in patients with primary immunodeficiency diseases. This new preparation for intravenous use includes three dedicated virus clearance steps in its manufacturing process to ensure a high margin of viral safety.


METHODS
This was a prospective, open-label, non-controlled, multicentre study. Twenty-two subjects with primary immunodeficiency were treated initially with three infusions of a licensed intravenous immunoglobulin to standardize the immunoglobulin G (IgG) replacement therapy of all subjects to the same intravenous product. A total of nine infusions of the new 10% liquid preparation were subsequently administered.


RESULTS
The median terminal half-life of total IgG following administration of the new preparation was 30.1 days. Median terminal half-lives for IgG subclasses IgG(1), IgG(2), IgG(3) and IgG(4) were 28.3, 31.3, 20.9 and 24.2 days, respectively. The median total serum IgG steady-state trough level was 8.51 g/l. No severe infection episodes started after initiation of treatment with the new preparation. The median rate of mild or moderate infection episodes was 0.48 per month. A total of 194 infusions with the new 10% liquid immunoglobulin preparation were administered. The mean dose per infusion was 0.41 g/kg body weight and the maximum infusion rates recorded were 8 ml/kg/h. Adverse experiences were mostly mild and unrelated to the study drugs. Only 4% of infusions with the new product were followed by one or more related adverse experiences.


CONCLUSIONS
The new 10% liquid immunoglobulin preparation was well tolerated and shown to have an excellent pharmacokinetic, efficacy and safety profile. The liquid formulation provides convenience to patients and healthcare professionals.
Björkander
J
J
SU/Sahlgrenska, Gothenburg, Sweden.
Nikoskelainen
J
J
Leibl
H
H
Lanbeck
P
P
Wallvik
J
J
Lumio
J T
JT
Braconier
J H
JH
Pavlova
B G
BG
Birthistle
K
K
Engl
W
W
Walter
S
S
Ehrlich
H J
HJ
D000328:Adult; D000361:Agammaglobulinemia / Q000150:complications / Q000628:therapy*; D000368:Aged; D004361:Drug Tolerance; D005260:Female; D006207:Half-Life; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000009:adverse effects / Q000493:pharmacokinetics* / Q000627:therapeutic use; D017053:Infection Control; D007239:Infections / Q000209:etiology; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012449:Safety
D016756:Immunoglobulins, Intravenous