A prospective observational post‐marketing study of natalizumab‐treated multiple sclerosis patients: clinical, radiological and biological features and adverse events. The BIONAT cohort

BIONAT is a French multicentric phase IV study of natalizumab (NTZ)‐treated relapsing−remitting multiple sclerosis (MS) patients. The purpose of this study was to collect clinical, radiological and biological data on 1204 patients starting NTZ, and to evaluate the clinical/radiological response to NTZ after 2 years of treatment.

[1]  G. Comi,et al.  Anti-JC virus antibody prevalence in a multinational multiple sclerosis cohort , 2013, Multiple sclerosis.

[2]  C. Pozzilli,et al.  Predictors of freedom from disease activity in natalizumab treated-patients with multiple sclerosis , 2012, Journal of the Neurological Sciences.

[3]  A. Damasceno,et al.  Disappearance of cerebrospinal fluid oligoclonal bands after natalizumab treatment of multiple sclerosis patients , 2012, Multiple sclerosis.

[4]  A. Svenningsson,et al.  Humoral immune response to influenza vaccine in natalizumab-treated MS patients , 2012, Neurological research.

[5]  H. Wiendl,et al.  Anti-JC virus antibodies in a large German natalizumab-treated multiple sclerosis cohort , 2012, Neurology.

[6]  Meena Subramanyam,et al.  Risk of natalizumab-associated progressive multifocal leukoencephalopathy. , 2012, The New England journal of medicine.

[7]  J. Chapman,et al.  Epidemiology of Anti-JCV Antibodies in Israeli Multiple Sclerosis Population (P02.138) , 2012 .

[8]  P. Vermersch,et al.  Anti-JCV antibody prevalence in a French cohort of MS patients under natalizumab therapy , 2012, Journal of Neurology.

[9]  G. Izquierdo,et al.  Immunological markers of optimal response to natalizumab in multiple sclerosis. , 2012, Archives of neurology.

[10]  A. Sandrock,et al.  Anti‐John Cunnigham virus antibody prevalence in multiple sclerosis patients: Baseline results of STRATIFY‐1 , 2011, Annals of neurology.

[11]  D. Bates,et al.  Treatment effect of natalizumab on relapse outcomes in multiple sclerosis patients despite ongoing MRI activity , 2011, Journal of Neurology, Neurosurgery & Psychiatry.

[12]  E. de Ramón,et al.  The efficacy of natalizumab in patients with multiple sclerosis according to level of disability: results of an observational study , 2011, Multiple sclerosis.

[13]  P. Vermersch,et al.  B-cell subsets up-regulate α4 integrin and accumulate in the cerebrospinal fluid in clinically isolated syndrome suggestive of multiple sclerosis onset , 2011, Neuroscience Letters.

[14]  G. Comi,et al.  Freedom from disease activity in multiple sclerosis , 2010, Neurology.

[15]  M. Edström,et al.  Natalizumab treatment in multiple sclerosis: marked decline of chemokines and cytokines in cerebrospinal fluid , 2010, Multiple Sclerosis.

[16]  P. Vermersch,et al.  Demographic and clinic characteristics of French patients treated with natalizumab in clinical practice , 2010, Journal of Neurology.

[17]  Adrian Egli,et al.  Prevalence of polyomavirus BK and JC infection and replication in 400 healthy blood donors. , 2009, The Journal of infectious diseases.

[18]  C. Polman,et al.  Effect of natalizumab on clinical and radiological disease activity in multiple sclerosis: a retrospective analysis of the Natalizumab Safety and Efficacy in Relapsing-Remitting Multiple Sclerosis (AFFIRM) study , 2009, The Lancet Neurology.

[19]  M. Krumbholz,et al.  Natalizumab disproportionately increases circulating pre-B and B cells in multiple sclerosis , 2008, Neurology.

[20]  Ludwig Kappos,et al.  A randomized, placebo-controlled trial of natalizumab for relapsing multiple sclerosis. , 2006, The New England journal of medicine.

[21]  X. Montalban,et al.  Defining the response to interferon‐β in relapsing‐remitting multiple sclerosis patients , 2006, Annals of neurology.

[22]  G. Comi,et al.  Three years of experience: the Italian registry and safety data update , 2010, Neurological Sciences.

[23]  F. Piehl,et al.  Swedish natalizumab (Tysabri) multiple sclerosis surveillance study , 2010, Neurological Sciences.

[24]  C. Pozzilli,et al.  Natalizumab treatment in multiple sclerosis: the experience of S. Andrea MS Centre in Rome , 2010, Neurological Sciences.

[25]  L. Kappos,et al.  The efficacy of natalizumab in patients with relapsing multiple sclerosis: subgroup analyses of AFFIRM and SENTINEL , 2009, Journal of Neurology.

[26]  A. Verma The incidence and significance of anti-natalizumab antibodies: Results from AFFIRM and SENTINEL , 2008 .