BACKGROUND AND OBJECTIVES: 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. MATERIALS AND 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. CONCLUSION: 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.
BACKGROUND AND OBJECTIVES: 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. MATERIALS AND 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. CONCLUSION: 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.
Authors: Richard L Wasserman; Isaac Melamed; Lisa Kobrynski; Steven D Strausbaugh; Mark R Stein; Marlies Sharkhawy; Werner Engl; Heinz Leibl; Luba Sobolevsky; David Gelmont; Richard I Schiff; William J Grossman Journal: J Clin Immunol Date: 2011-03-22 Impact factor: 8.317
Authors: Melvin Berger; Charlotte Cunningham-Rundles; Francisco A Bonilla; Isaac Melamed; Johann Bichler; Othmar Zenker; Mark Ballow Journal: J Clin Immunol Date: 2007-05-04 Impact factor: 8.317
Authors: Michael Borte; Isaac R Melamed; Grazyna Pulka; Barbara Pyringer; Alan P Knutsen; Hans D Ochs; Roger H Kobayashi; Ai Lan Kobayashi; Sudhir Gupta; Magdalena Strach; William Smits; Anna Pituch-Noworolska; James N Moy Journal: J Clin Immunol Date: 2017-07-29 Impact factor: 8.317
Authors: Laia Alsina; Andreas Mohr; Maria Montañés; Xènia Oliver; Esperanza Martín; Jaime Pons; Elizabeth Drewe; Jens Papke; Georg Günther; Ronnie Chee; Mark Gompels Journal: Pharmacol Res Perspect Date: 2017-10