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Volume 25, Number 11—November 2019
CME ACTIVITY - Research

Lack of Efficacy of High-Titered Immunoglobulin in Patients with West Nile Virus Central Nervous System Disease

John W. GnannComments to Author , 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. WhitleyComments to Author , and for the National Institute of Allergy and Infectious Diseases Collaborative Antiviral Study Group
Author affiliations: University of Alabama at Birmingham, Birmingham, Alabama, USA (J.W. Gnann, Jr., P. Jester, I. Dale, Y. Li, I. Aban, F.D. Lakeman, R.J. Whitley); National Institutes of Health Clinical Center, Bethesda, Maryland, USA (A. Agrawal, H. Masur); University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA (J. Hart); Idaho Falls Infectious Diseases PLLC, Idaho Falls, Idaho, USA (M. Buitrago); North Dakota State University, Fargo, North Dakota, USA (P. Carson); University of New Mexico, Albuquerque, New Mexico, USA (D. Hanfelt-Goade); University of Colorado at Denver Anschutz Medical Campus, Aurora, Colorado, USA (K. Tyler); Kaiser Permanente South Bay Medical Center, Harbor City, California, USA (J. Spotkov); University of Nebraska Medical Center, Omaha, Nebraska, USA (D. Freifeld); Via Christi Hospital St. Francis, Wichita, Kansas, USA (T. Moore); Infectious Diseases Consultations, Rapid City, South Dakota, USA (J. Reyno)

Main Article

Table 4

Summary of SAEs in intent-to-treat population in study of treatments for West Nile virus central nervous system disease, by treatment arm*

Characteristic Omr-IgG-am, n = 37 Polygam, n = 12 Normal saline, n = 13 Total, n = 62
SAEs 29 25 9 63
Patients with an SAE 19 (51.4) 7 (58.3) 3 (23.1) 29 (46.8)
SAEs per patient
 1.53
 3.57
 3.0
 2.17
Relationship to treatment†
Unrelated 27 (93.1) 24 (96.0) 7 (77.8) 58 (92.1)
Related
 2 (6.9)
 1 (4.0)
 2 (22.2)
 5 (7.9)
Severity†
Mild 1 (3.4) 0 0 1 (1.6)
Moderate 4 (13.8) 3 (12.0) 0 7 (11.1)
Severe 9 (31.0) 8 (32.0) 4 (44.4) 21 (33.3)
Life-threatening 11 (37.9) 11 (44.0) 4 (44.4) 26 (41.3)
Death 4 (13.8) 3 (12.0) 1 (11.1) 8 (12.7)

*Values are no. (%) except as indicated. In comparing Omr-IgG-am with Polygam and Omr-IgG-am with normal saline, no significant differences were identified for characteristics listed in this table (all p values >0.05) except for mild severity Omr-IgG-am vs. Polygam (p<0.01). SAE, serious adverse event.
†As assessed by the investigator.

Main Article

Page created: October 15, 2019
Page updated: October 15, 2019
Page reviewed: October 15, 2019
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