Anti-John Cunnigham virus antibody prevalence in multiple sclerosis patients: Baseline results of STRATIFY-1

• Published in: Annals of neurology Vol. 70; no. 5; pp. 742 - 750
• Main Authors: Bozic, Carmen, Richman, Sandra, Plavina, Tatiana, Natarajan, Amy, Scanlon, James V., Subramanyam, Meena, Sandrock, Alfred, Bloomgren, Gary
• Format: Journal Article
• Language: English
• Published: Hoboken Wiley Subscription Services, Inc., A Wiley Company 01.11.2011; Wiley-Liss; Wiley Subscription Services, Inc
• Subjects: Adult; Age Factors; Antibodies, Monoclonal, Humanized - therapeutic use; Antibodies, Viral - blood; Biological and medical sciences; Confidence intervals; DNA, Viral - urine; Female; HIV; Human immunodeficiency virus; Humans; JC virus; JC Virus - genetics; JC Virus - immunology; Longitudinal Studies; Male; Medical research; Medical sciences; Middle Aged; Multiple sclerosis; Multiple Sclerosis - blood; Multiple Sclerosis - drug therapy; Multiple Sclerosis - immunology; Multiple Sclerosis - urine; Multiple sclerosis and variants. Guillain barré syndrome and other inflammatory polyneuropathies. Leukoencephalitis; Natalizumab; Neurology; Prevalence; United States - epidemiology; United States; Human; Virus; Nervous system diseases; Multiple sclerosis; Prevalence; Central nervous system disease; Inflammatory disease
• ISSN: 0364-5134; 1531-8249
• DOI: 10.1002/ana.22606

Objective: A study was undertaken to define the prevalence of anti‐JC virus (JCV) antibodies in multiple sclerosis (MS) patients and to evaluate the analytical false‐negative rate of a 2‐step anti‐JC virus antibody assay. Methods: STRATIFY‐1 is an ongoing, longitudinal, observational study of relapsing MS patients in the United States who are being treated or considering treatment with natalizumab. Baseline serum and plasma samples were collected for anti‐JC virus antibody detection using an analytically validated, 2‐step, virus‐like particle‐based enzyme‐linked immunosorbent assay. Urine was collected for JC virus DNA detection. Results: At baseline (n = 1,096), overall anti‐JC virus antibody prevalence was 56.0% (95% confidence interval [CI], 53.0‐59.0) in STRATIFY‐1 patients, with an assay false‐negative rate of 2.7% (95% CI, 0.9–6.2). Prevalence was significantly lower in females (53.4%; 95% CI, 49.9–56.8) than males (64.3%; 95% CI, 58.2–70.0) and increased with age, p = 0.0019 and p = 0.0001, respectively. Prevalence was similar in patients regardless of natalizumab exposure or prior immunosuppressant use, p = 0.9709 and p = 0.6632, respectively. STRATIFY‐1 results were generally consistent with those observed in another large North American cohort, TYGRIS‐US (n = 1,480). Interpretation: Baseline results from STRATIFY‐1 are consistent with other studies utilizing this assay that demonstrate a 50 to 60% prevalence of anti‐JC virus antibodies, a low false‐negative rate, and an association of increasing age and male gender with increasing anti‐JC virus antibody prevalence. Neither natalizumab exposure nor prior immunosuppressant use appear to affect prevalence. Longitudinal data from STRATIFY‐1 will confirm the stability of anti‐JC virus antibody prevalence over time. ANN NEUROL 2011