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

被引：33

作者：

Outteryck, O. ^{[1
]}

Ongagna, J. C. ^{[2
]}

Brochet, B. ^{[3
]}

Rumbach, L. ^{[4
]}

Lebrun-Frenay, C. ^{[5
]}

Debouverie, M. ^{[6
]}

Zephir, H. ^{[1
]}

Ouallet, J. C. ^{[3
]}

Berger, E. ^{[4
]}

Cohen, M. ^{[5
]}

Pittion, S. ^{[6
]}

Laplaud, D. ^{[7
]}

Wiertlewski, S. ^{[7
]}

Cabre, P. ^{[8
]}

Pelletier, J. ^{[9
]}

Rico, A. ^{[9
]}

Defer, G. ^{[10
]}

Derache, N. ^{[10
]}

Camu, W. ^{[11
]}

Thouvenot, E. ^{[12
]}

Moreau, T. ^{[13
]}

Fromont, A. ^{[13
]}

Tourbah, A. ^{[14
]}

Labauge, P. ^{[11
]}

Castelnovo, G. ^{[12
]}

Clavelou, P. ^{[15
]}

Casez, O. ^{[16
]}

Hautecoeur, P. ^{[17
]}

Papeix, C. ^{[18
]}

Lubetzki, C. ^{[18
]}

Fontaine, B. ^{[18
]}

Couturier, N. ^{[19
]}

Bohossian, N. ^{[19
]}

Clanet, M. ^{[19
]}

Vermersch, P. ^{[1
]}

de Seze, J. ^{[2
]}

Brassat, D. ^{[19
]}

机构：

[1] Univ Lille Nord France EA2686, Hop Roger Salengro CHRU Lille, Lille, France

[2] Hop Civil, Strasbourg, France

[3] CHU Pellegrin, Bordeaux, France

[4] CHU Besancon, F-25030 Besancon, France

[5] Hop Louis Pasteur, F-06002 Nice, France

[6] CHU Nancy, Nancy, France

[7] CHU Nantes, F-44035 Nantes 01, France

[8] CHU Ft France, Fort De France, France

[9] Hop Enfants La Timone, Marseille, France

[10] CHU Caen, F-14000 Caen, France

[11] CHU Montpellier, Montpellier, France

[12] CHU Nimes, Nimes, France

[13] CHU Dijon, Dijon, France

[14] CHU Reims, Reims, France

[15] CHR Univ Clermont Ferrand, Clermont Ferrand, France

[16] CHU Grenoble, F-38043 Grenoble, France

[17] GHICL, CH St Vincent, Lille, France

[18] Hop La Pitie Salpetriere, Paris, France

[19] Pole Neurosci CHU Purpan, INSERM, U1043, Toulouse, France

来源：

EUROPEAN JOURNAL OF NEUROLOGY | 2014年 / 21卷 / 01期

关键词：

biomarker; BIONAT; JCV; multiple sclerosis; natalizumab; progressive multifocal leukoencephalopathy; DISEASE-ACTIVITY; CEREBROSPINAL-FLUID; EFFICACY; FREEDOM; AFFIRM;

D O I：

10.1111/ene.12204

中图分类号：

R74 [神经病学与精神病学];

学科分类号：

摘要：

Background and purposeBIONAT 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 2years of treatment. MethodsPatients starting NTZ at 18 French MS centres since June 2007 were included. Good response to NTZ was defined by the absence of clinical and radiological activity. Data analysed in this first report on the BIONAT study focus on patients who started NTZ at least 2years ago (n=793; BIONAT(2Y)). ResultsNTZ was discontinued in 17.78% of BIONAT(2Y). The proportion of patients without combined disease activity was 45.59% during the first two successive years of treatment. Systematic dosage of anti-NTZantibodies (Abs) detected only two supplementary patients with anti-NTZ Abs compared with strict application of recommendations. A significant decrease of IgG,M concentrations at 2years of treatment was found. ConclusionsThe efficacy of NTZ therapy on relapsing-remitting MS in a real life setting is confirmed in the BIONAT cohort. The next step will be the identification of biomarkers predicting response to NTZ therapy and adverse events.

引用

页码：40 / 48

页数：9

共 44 条

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