Efficacy, Safety, and Pharmacokinetics of a New 10 % Liquid Intravenous Immunoglobulin Containing High Titer Neutralizing Antibody to RSV and Other Respiratory Viruses in Subjects with Primary Immunodeficiency Disease

Wasserman, Richard L.; Lumry, William; Harris, James; Levy, Robyn; Stein, Mark; Forbes, Lisa; Cunningham-Rundles, Charlotte; Melamed, Isaac; Kobayashi, Ai Lan; Du, Wei; Kobayashi, Roger

Keywords Intravenous immunoglobulin (IVIG) . primary immunodeficiency (PIDD) . clinical trial . safety . efficacy . pharmacokinetics Introduction Immunoglobulin (IG) supplementation has been the standard treatment for patients with disorders of antibody production due to B cell or combined B and T cell abnormalities (PIDD) [1] [2] [3] [4] [5] . Regularly scheduled infusions of IG replace or supplement antibodies that decrease the risk of the serious bacterial and viral infections experienced by PIDD patients [6] [7] [8] . Although all available preparations of immune globulin provide sufficient antibodies to significantly decrease the frequency of infections in immunodeficient patients, infections continue to occur [2, 6] . Previous studies have suggested that some infections in antibody-deficient PIDD patients occur when the titer of protective antibody is inadequate [9] [10] [11] [12] . While many of these reports have focused on bacterial pathogens, additional evidence supports the proposition that high titer anti-viral antibody preparations may provide advantages over conventional IG [13, 14] .