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

There were no SAEs reported during the trial attributable to the study drug. Two serious adverse events (SAEs) were reported, one instance each of post-operative wound infection and migraine. Neither SAE was associated with the study drug; each event was experienced as a single occurrence in a single subject. There was a low incidence of adverse infusion reactions, with a total of 31 events experienced by 18 subjects (30.5 %) during 29 infusions (3.7 %). The most frequently reported events included headache and myalgia. A total of four infusion site reactions were reported in this study in two subjects. The infusion site reactions reported included infusion site extravasation and infusion site pain. There was no evidence of a trend towards significant changes in any of the laboratory assessments during treatment with study medication. End of study laboratory assessments were generally similar to screening assessments, with no trends noted. There was no laboratory evidence of any instances of a thrombotic event, acute renal failure, hemolysis event, viral transmission, aseptic meningitis, or transfusion-related acute lung injury.