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

us) as compared to ten other commercial lots of IG [27] . This preparation of RI-002, therefore, can be regarded as having a unique antibody profile for multiple respiratory viruses that differentiates it from other commercially available IGs. Viewed in the context of data from other IG trials, there are many of the secondary efficacy endpoints, for example number of days missed from [25, [28] [29] [30] . This study demonstrated excellent outcomes that might reflect the unique antibody profile of RI-002. The efficacy of RI-002 is likely the result of the maintenance of stable IgG trough levels as well as specific antibody levels throughout the study conferring the expected protective effects of IG therapy. The pharmacokinetic properties of RI-002 were comparable to previous reports of IVIG preparations. All subjects maintained average trough levels of serum Ig of approximately 1000 mg/kg. There were significant postinfusion increases in all of the specific antibody titers measured with a greater than 6-fold increase seen in the concentration of RSV-neutralizing antibody immediately postinfusion in patients receiving greater than 500 mg/kg of IG.