Comparative efficacy of fingolimod vs natalizumab A French multicenter observational study

被引：70

作者：

Barbin, Laetitia ^{[1
]}

Rousseau, Chloe ^{[1
,2
,3
]}

Jousset, Natacha ^{[1
]}

Casey, Romain ^{[4
]}

Debouverie, Marc

Vukusic, Sandra ^{[4
,5
]}

De Seze, Jerome ^{[6
,34
]}

Brassat, David ^{[7
]}

Wiertlewski, Sandrine ^{[8
]}

Brochet, Bruno ^{[9
]}

Pelletier, Jean ^{[10
]}

Vermersch, Patrick ^{[11
]}

Edan, Gilles ^{[12
]}

Lebrun-Frenay, Christine ^{[13
]}

Clavelou, Pierre ^{[14
]}

Thouvenot, Eric ^{[15
]}

Camdessanche, Jean-Philippe ^{[16
]}

Tourbah, Ayman ^{[17
,18
]}

Stankoff, Bruno ^{[19
]}

Al Khedr, Abdullatif ^{[20
]}

Cabre, Philippe ^{[21
]}

Papeix, Caroline ^{[22
]}

Berger, Eric ^{[23
]}

Heinzlef, Olivier ^{[24
]}

Debroucker, Thomas ^{[25
]}

Moreau, Thibault ^{[26
]}

Gout, Olivier ^{[27
]}

Bourre, Bertrand ^{[28
]}

Creange, Alain ^{[29
]}

Labauge, Pierre ^{[30
]}

Magy, Laurent ^{[31
]}

Defer, Gilles ^{[32
]}

Foucher, Yohann ^{[2
]}

Laplaud, David A. ^{[1
,8
,33
]}

机构：

[1] INSERM, CIC 0004, Nantes, France

[2] Nantes Univ, Clin Res & Subject Measures Hlth Sci, EA Biostat 4275, Nantes, France

[3] Univ Rennes 1, CHU Rennes, CIC Inserm 1414, Serv Pharmacol Clin, Rennes, France

[4] Univ Lyon, Hosp Civils Lyon, Observ Francais Sclerose Plaques, Lyon, France

[5] CHU Nancy, Serv Neurol, Nancy, France

[6] CHU Lyon, Serv Neurol, Lyon, France

[7] CHU Toulouse, Serv Neurol, Toulouse, France

[8] CHU Nord Laennec, Serv Neurol, Nantes, France

[9] CHU Bordeaux, Serv Neurol, Bordeaux, France

[10] CHU Marseille, Serv Neurol, Marseille, France

[11] CHU Lille, Serv Neurol, Lille, France

[12] CHU Rennes, Serv Neurol, Rennes, France

[13] CHU Nice, Serv Neurol, Nice, France

[14] CHU Clermont Ferrand, Serv Neurol, Clermont Ferrand, France

[15] CHU Nimes, Serv Neurol, Nimes, France

[16] CHU St Etienne, Serv Neurol, St Etienne, France

[17] URCA, CHU Reims, Serv Neurol, Reims, France

[18] URCA, CHU Reims, Fac Med Reims, Reims, France

[19] CHU St Antoine, Serv Neurol, Paris, France

[20] CHU Amiens, Serv Neurol, Amiens, France

[21] CHU Ft France, Serv Neurol, Fort de France, France

[22] CHU Paris Salpetriere, Serv Neurol, Paris, France

[23] CHU Besancon, Serv Neurol, Besancon, France

[24] CHU Poissy, Serv Neurol, St Germain En Laye, France

[25] CHU St Denis, Serv Neurol, St Denis, France

[26] CHU Dijon, Serv Neurol, Dijon, France

[27] Fdn Adolphe De Rothschild, Serv Neurol, Paris, France

[28] CHU Rouen, Serv Neurol, Rouen, France

[29] CHU Creteil, Serv Neurol, Creteil, France

[30] CHU Montpellier, Serv Neurol, Montpellier, France

[31] CHU Limoges, Serv Neurol, Caen, France

[32] CHU Caen, Serv Neurol, Caen, France

[33] INSERM, UMR U1064, Nantes, France

[34] CHU Strasbourg, Serv Neurol, Strasbourg, France

来源：

NEUROLOGY | 2016年 / 86卷 / 08期

关键词：

RELAPSING MULTIPLE-SCLEROSIS; PLACEBO-CONTROLLED TRIAL; PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY; ORAL FINGOLIMOD;

D O I：

10.1212/WNL.0000000000002395

中图分类号：

R74 [神经病学与精神病学];

学科分类号：

摘要：

Objective: To compare natalizumab and fingolimod on both clinical and MRI outcomes in patients with relapsing-remitting multiple sclerosis (RRMS) from 27 multiple sclerosis centers participating in the French follow-up cohort Observatoire of Multiple Sclerosis. Methods: Patients with RRMS included in the study were aged from 18 to 65 years with an Expanded Disability Status Scale score of 0-5.5 and an available brain MRI performed within the year before treatment initiation. The data were collected for 326 patients treated with natalizumab and 303 with fingolimod. The statistical analysis was performed using 2 different methods: logistic regression and propensity scores (inverse probability treatment weighting). Results: The confounder-adjusted proportion of patients with at least one relapse within the first and second year of treatment was lower in natalizumab-treated patients compared to the fingolimod group (21.1% vs 30.4% at first year, p = 0.0092; and 30.9% vs 41.7% at second year, p = 0.0059) and supported the trend observed in nonadjusted analysis (21.2% vs 27.1% at 1 year, p = 0.0775). Such statistically significant associations were also observed for gadolinium (Gd)-enhancing lesions and new T2 lesions at both 1 year (Gd-enhancing lesions: 9.3% vs 29.8%, p < 0.0001; new T2 lesions: 10.6% vs 29.6%, p < 0.0001) and 2 years (Gd-enhancing lesions: 9.1% vs 22.1%, p = 0.0025; new T2 lesions: 16.9% vs 34.1%, p = 0.0010) post treatment initiation. Conclusion: Taken together, these results suggest the superiority of natalizumab over fingolimod to prevent relapses and new T2 and Gd-enhancing lesions at 1 and 2 years. Classification of evidence: This study provides Class IV evidence that for patients with RRMS, natalizumab decreases the proportion of patients with at least one relapse within the first year of treatment compared to fingolimod.

引用

页码：771 / 778

页数：8

共 17 条

[1]

[Anonymous], 2010, R LANG ENV STAT COMP

[2] Second line use of Fingolimod is as effective as Natalizumab in a German out-patient RRMS-cohort [J].