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

The present study was a prospective, open-label, nonrandomized multicenter phase 3 study in the USA to evaluate the efficacy and safety of RI-002 in patients with PIDD. The primary objective was to evaluate the annualized acute serious bacterial infection rate. Secondary objectives including evaluation of missed days of work due to infection, unscheduled visits to the physician, days hospitalized due to infection as well as the safety and tolerability of RI-002 were also studied. Pharmacokinetic studies measured not only concentrations of total immune globulin, but also measured the concentrations of antibodies to RSV, cytomegalovirus (CMV), tetanus toxoid, Haemophilus influenzae type b (Hib), measles, and 13 serotypes of Streptococcus pneumoniae.