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 blood samples for PK analysis were obtained beginning after Infusion 7 or Infusion 9 in order to allow for wash out of the previous IG product. Scheduled sampling times were as follows: immediately prior to the infusion, end of the infusion, 60 min, 2 h, 24 h, 48 h, 4 days, 7 days, 14 days, 21 days, and 28 days post-infusion. All PK parameters were calculated using non-compartmental analysis. Only those plasma concentrations equal to or greater than the validated lower limit of quantitation of the individual antibody assays were used in the analysis. Actual sampling times were used in all pharmacokinetic analyses. Per protocol times were used to calculate mean plasma concentrations for graphical displays. Calculated PK parameters included: elimination constant (K), elimination half-life (t½), area under the curve (AUC (0t) ) over the 21 or 28-day dosing interval, total plasma clearance (CL), and volume of distribution (Vz). Levels of specific antibody to CMV, tetanus, Hib, measles, and RSV were determined at each time point.