Literature DB >> 20547618

No evidence of JC virus reactivation in natalizumab treated multiple sclerosis patients: an 18 month follow-up study.

Luciano Rinaldi1, Francesca Rinaldi, Paola Perini, Massimiliano Calabrese, Dario Seppi, Paola Grossi, Irene Mattisi, Luisa Barzon, Carlo Mengoli, Mariella Sanzari, Giorgio Palú, Paolo Gallo.   

Abstract

BACKGROUND AND AIM: Natalizumab, used as therapy for multiple sclerosis (MS), has been associated with progressive multifocal leucoencephalopathy (PML), a potentially fatal disease caused by JC virus (JCV), which is not predictable by specific markers. This study evaluated whether JCV reactivation occurred in the urine and/or plasma in 42 MS patients treated with natalizumab over 18 months, and followed by a thorough monitoring programme.
METHODS: 42 patients (F/M: 24/18, mean age 34.4±8.9 years) were followed-up by: urine and plasma JCV-DNA PCR assay, immune cell subsets analysis, clinical and MRI evaluation, quality of life, fatigue and mood assessment.
RESULTS: JCV data. At baseline, 11/42 (26%) patients had JCV viruria, persistent at serial controls. One patient acquired viruria at month 1 and one patient at month 12. No patient had JCV viraemia at baseline; three patients acquired viraemic (one at month 6, one at month 13 (both transiently) and one at month 12 (persistently viraemic)). The prevalence of JCV in both urine and plasma did not change significantly from baseline to months 12 and 18. No patient had clinical or MRI evidence of PML. Immunological data. Circulating B cells showed greater expansion (300% increase in absolute number) since the first infusion. NK cell count doubled with no change in percentage while T cell count increased with a reduced percentage, reflecting a clear redistribution in the lymphocyte compartment. CD4+ and CD8+ T cells increased proportionally, with no change in their percentage. Clinical data. 27 patients (64%) were disease free after 1 year. A marked improvement in quality of life was reported by 72% of patients.
CONCLUSIONS: No evidence of subclinical JCV reactivation was found in our natalizumab treated MS patients up to 18 months of therapy, notwithstanding the marked increase in circulating B cells observed. Moreover, the efficacy of natalizumab, its tolerability and the positive impact on quality of life were confirmed in this study.

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Year:  2010        PMID: 20547618     DOI: 10.1136/jnnp.2009.201079

Source DB:  PubMed          Journal:  J Neurol Neurosurg Psychiatry        ISSN: 0022-3050            Impact factor:   10.154


  12 in total

Review 1.  Concordance of preclinical and clinical pharmacology and toxicology of therapeutic monoclonal antibodies and fusion proteins: cell surface targets.

Authors:  Peter J Bugelski; Pauline L Martin
Journal:  Br J Pharmacol       Date:  2012-06       Impact factor: 8.739

Review 2.  Progressive multifocal leukoencephalopathy and natalizumab.

Authors:  Kerstin Hellwig; Ralf Gold
Journal:  J Neurol       Date:  2011-06-07       Impact factor: 4.849

Review 3.  Molecular biology, epidemiology, and pathogenesis of progressive multifocal leukoencephalopathy, the JC virus-induced demyelinating disease of the human brain.

Authors:  Michael W Ferenczy; Leslie J Marshall; Christian D S Nelson; Walter J Atwood; Avindra Nath; Kamel Khalili; Eugene O Major
Journal:  Clin Microbiol Rev       Date:  2012-07       Impact factor: 26.132

4.  Increased frequency of JC-polyomavirus detection in rheumatoid arthritis patients treated with multiple biologics.

Authors:  Jens Verheyen; Kseniya Maizus; Eugen Feist; Zebulon Tolman; Elena Knops; Jasemine Saech; Lydia Spengler; Tim Waterboer; Gerd R Burmester; Michael Pawlita; Herbert Pfister; Andrea Rubbert-Roth
Journal:  Med Microbiol Immunol       Date:  2015-02-13       Impact factor: 3.402

5.  JC virus urinary excretion and seroprevalence in natalizumab-treated multiple sclerosis patients.

Authors:  Serena Delbue; Francesca Elia; Camilla Carloni; Valentina Pecchenini; Diego Franciotta; Matteo Gastaldi; Elena Colombo; Lucia Signorini; Silvia Carluccio; Anna Bellizzi; Roberto Bergamaschi; Pasquale Ferrante
Journal:  J Neurovirol       Date:  2014-07-23       Impact factor: 2.643

6.  Anti-JCV antibodies detection and JCV DNA levels in PBMC, serum and urine in a cohort of Spanish Multiple Sclerosis patients treated with natalizumab.

Authors:  Maria Inmaculada Dominguez-Mozo; Marta Garcia-Montojo; Virginia De Las Heras; Angel Garcia-Martinez; Ana María Arias-Leal; Ignacio Casanova; Rafael Arroyo; Roberto Alvarez-Lafuente
Journal:  J Neuroimmune Pharmacol       Date:  2013-08-25       Impact factor: 4.147

7.  JC virus detection and JC virus-specific immunity in natalizumab-treated multiple sclerosis patients.

Authors:  Roberta Mancuso; Marina Saresella; Ambra Hernis; Ivana Marventano; Cristian Ricci; Simone Agostini; Marco Rovaris; Domenico Caputo; Mario Clerici
Journal:  J Transl Med       Date:  2012-12-11       Impact factor: 5.531

Review 8.  A review on JC virus infection in kidney transplant recipients.

Authors:  Serena Delbue; Mariano Ferraresso; Luciana Ghio; Camilla Carloni; Silvia Carluccio; Mirco Belingheri; Alberto Edefonti; Pasquale Ferrante
Journal:  Clin Dev Immunol       Date:  2013-01-29

Review 9.  JC polyomavirus (JCV) and monoclonal antibodies: friends or potential foes?

Authors:  Roberta Antonia Diotti; Akira Nakanishi; Nicola Clementi; Nicasio Mancini; Elena Criscuolo; Laura Solforosi; Massimo Clementi
Journal:  Clin Dev Immunol       Date:  2013-06-25

10.  Clinical baseline factors predict response to natalizumab: their usefulness in patient selection.

Authors:  Alice Laroni; Ilaria Gandoglia; Claudio Solaro; Giuseppe Ribizzi; Tiziana Tassinari; Matteo Pizzorno; Sergio Parodi; Giovanna Baldassarre; Maria Teresa Rilla; Simonetta Venturi; Elisabetta Capello; Maria Pia Sormani; Antonio Uccelli; Giovanni Luigi Mancardi
Journal:  BMC Neurol       Date:  2014-05-12       Impact factor: 2.474

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