Lack of Efficacy of High-Titered Immunoglobulin in Patients with West Nile Virus Central Nervous System Disease
oleh: John W. Gnann, Amy Agrawal, John Hart, Martha Buitrago, Paul Carson, Diane Hanfelt-Goade, Ken Tyler, Jared Spotkov, Alison Freifeld, Thomas Moore, Jorge Reyno, Henry Masur, Penelope Jester, Ilet Dale, Yufeng Li, Inmaculada Aban, Fred D. Lakeman, Richard J. Whitley
| Format: | Article |
|---|---|
| Diterbitkan: | Centers for Disease Control and Prevention 2019-11-01 |
Deskripsi
West Nile Virus (WNV) can result in clinically severe neurologic disease. There is no treatment for WNV infection, but administration of anti-WNV polyclonal human antibody has demonstrated efficacy in animal models. We compared Omr-IgG-am, an immunoglobulin product with high titers of anti-WNV antibody, with intravenous immunoglobulin (IVIG) and normal saline to assess safety and efficacy in patients with WNV neuroinvasive disease as part of a phase I/II, randomized, double-blind, multicenter study in North America. During 2003–2006, a total of 62 hospitalized patients were randomized to receive Omr-IgG-am, standard IVIG, or normal saline (3:1:1). The primary endpoint was medication safety. Secondary endpoints were morbidity and mortality, measured using 4 standardized assessments of cognitive and functional status. The death rate in the study population was 12.9%. No significant differences were found between groups receiving Omr-IgG-am compared with IVIG or saline for either the safety or efficacy endpoints.