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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 2

Summary of AEs in intent-to-treat population of patients 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
AEs 514 106 118 738
patients with an AE 36 (97.3) 11 (91.7) 58 (93.5) 58 (93.5)
AEs per patient
 14.28
 9.64
 10.73
 12.72
Relationship to treatment†
Unrelated 482 (93.8) 99 (93.4) 113 (95.8) 694 (94)
Related 29 (5.6) 7 (6.6) 5 (4.2) 41 (5.6)
Not stated
 3 (0.6)
 0
 0
 3 (0.4)
Severity of AE†
Mild 226 (44.0) 45 (42.5) 61 (51.7) 332 (45.0)
Moderate 221 (43.0) 34 (32.1) 45 (38.1) 300 (40.7)
Severe 54 (10.5) 13 (12.3) 9 (7.6) 76 (10.3)
Life-threatening 13 (2.5) 14 (13.2) 3 (2.5) 30 (4.1)

*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). AE, 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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