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Effects of early treatment with glatiramer acetate in patients with clinically isolated syndrome

Identifieur interne : 000944 ( PascalFrancis/Corpus ); précédent : 000943; suivant : 000945

Effects of early treatment with glatiramer acetate in patients with clinically isolated syndrome

Auteurs : Giancarlo Comi ; Vittorio Martinelli ; Mariaemma Rodegher ; Lucia Moiola ; Letizia Leocani ; Ovidiu Bajenaru ; Adriana Carra ; Irina Elovaara ; Franz Fazekas ; Hans-Peter Hartung ; Jan Hillert ; John King ; Samuel Komoly ; Catherine Lubetzki ; Xavier Montalban ; Kjell-Morten Myhr ; Paolo Preziosa ; Mads Ravnborg ; Peter Rieckmann ; Maria A. Rocca ; Daniel Wynn ; Carolyn Young ; Massimo Filippi

Source :

RBID : Pascal:13-0239401

Descripteurs français

English descriptors

Abstract

Background: The placebo-controlled phase of the PreCISe study showed that glatiramer acetate delayed onset of clinically definite multiple sclerosis (CDMS) in patients with clinically isolated syndrome and brain lesions on MRI. Objective: To compare the effects of early versus delayed glatiramer acetate treatment in the open-label phase of PreCISe. Methods: Patients with a clinically isolated syndrome suggestive of MS with unifocal manifestation and ≥2 T2-weighted brain lesions were randomized to receive glatiramer acetate 20 mg/d (early-treatment, n=198) or placebo (delayed-treatment, n=211) for 36 months or until conversion to CDMS, followed by open-label glatiramer acetate treatment for two years. Results: Early glatiramer acetate treatment reduced CDMS conversion risk by 41% (hazard ratio 0.59, 95% confidence interval 0.44-0.80; p=0.0005) versus delayed-treatment, and was associated with a 972-day delay (185%) in conversion to CDMS, less brain atrophy (-28%, p=0.0209), fewer new T2 lesions/year (-42%, <0.0001) and lower T2 lesion volume (-22%, p=0.0005) versus delayed treatment. Adverse events were consistent with the established safety profile of glatiramer acetate. Conclusions: Effects of early glatiramer acetate treatment on the rate of conversion to CDMS and on MRI measures of disease activity and lesion burden support initiating glatiramer acetate treatment soon after the first clinical symptoms suggestive of MS and continuing treatment to sustain benefits.

Notice en format standard (ISO 2709)

Pour connaître la documentation sur le format Inist Standard.

pA  
A01 01  1    @0 1352-4585
A03   1    @0 Mult. scler.
A05       @2 19
A06       @2 8
A08 01  1  ENG  @1 Effects of early treatment with glatiramer acetate in patients with clinically isolated syndrome
A11 01  1    @1 COMI (Giancarlo)
A11 02  1    @1 MARTINELLI (Vittorio)
A11 03  1    @1 RODEGHER (Mariaemma)
A11 04  1    @1 MOIOLA (Lucia)
A11 05  1    @1 LEOCANI (Letizia)
A11 06  1    @1 BAJENARU (Ovidiu)
A11 07  1    @1 CARRA (Adriana)
A11 08  1    @1 ELOVAARA (Irina)
A11 09  1    @1 FAZEKAS (Franz)
A11 10  1    @1 HARTUNG (Hans-Peter)
A11 11  1    @1 HILLERT (Jan)
A11 12  1    @1 KING (John)
A11 13  1    @1 KOMOLY (Samuel)
A11 14  1    @1 LUBETZKI (Catherine)
A11 15  1    @1 MONTALBAN (Xavier)
A11 16  1    @1 MYHR (Kjell-Morten)
A11 17  1    @1 PREZIOSA (Paolo)
A11 18  1    @1 RAVNBORG (Mads)
A11 19  1    @1 RIECKMANN (Peter)
A11 20  1    @1 ROCCA (Maria A.)
A11 21  1    @1 WYNN (Daniel)
A11 22  1    @1 YOUNG (Carolyn)
A11 23  1    @1 FILIPPI (Massimo)
A14 01      @1 Institute of Experimental Neurology, Department of Neurology, University Vita-Salute, Scientific Institute San Raffaele @2 Milan @3 ITA @Z 1 aut. @Z 2 aut. @Z 3 aut. @Z 4 aut. @Z 5 aut.
A14 02      @1 University of Medicine and Pharmacy 'Carol Davila' Bucharest, Department of Neurology, University Hospital of Emergency @3 ROU @Z 6 aut.
A14 03      @1 Hospital Británico de Buenos Aires @3 ARG @Z 7 aut.
A14 04      @1 University of Tampere, Medical School, Department of Neurology @3 FIN @Z 8 aut.
A14 05      @1 Department of Neurology, Medical University Graz @3 AUT @Z 9 aut.
A14 06      @1 Department of Neurology, Heinrich-Heine-University @2 Düsseldorf @3 DEU @Z 10 aut.
A14 07      @1 Huddinge University Hospital, Department of Neurology @2 Stockholm @3 SWE @Z 11 aut.
A14 08      @1 Royal Melbourne Hospital, Department of Neurology @2 Parkville @3 AUS @Z 12 aut.
A14 09      @1 Department of Neurology, University of Pecs @3 HUN @Z 13 aut.
A14 10      @1 Department of Neurology, Clinical Research Centre, Hôpital Pitié Salpêtrière @2 Paris @3 FRA @Z 14 aut.
A14 11      @1 Hospital General Universitari Vall d'Hebrón @2 Barcelona @3 ESP @Z 15 aut.
A14 12      @1 The Norwegian Multiple Sclerosis Competence Centre, Department of Neurology, Haukeland University Hospital @2 Bergen @3 NOR @Z 16 aut.
A14 13      @1 Institute of Experimental Neurology, Division of Neuroscience, University Vita-Salute and Scientific Institute San Raffaele @2 Milan @3 ITA @Z 17 aut. @Z 20 aut. @Z 23 aut.
A14 14      @1 Department of Neurology, Odense University Hospital @3 DNK @Z 18 aut.
A14 15      @1 Department of Neurology, Academic Hospital Bamberg, University of Erlangen @3 DEU @Z 19 aut.
A14 16      @1 Consultants in Neurology Multiple Sclerosis Centre, Department of Clinical Research @2 Northbrook, IL @3 USA @Z 21 aut.
A14 17      @1 Walton Centre for Neurology and Neurosurgery @2 Liverpool @3 GBR @Z 22 aut.
A20       @1 1074-1083
A21       @1 2013
A23 01      @0 ENG
A43 01      @1 INIST @2 26577 @5 354000503883140150
A44       @0 0000 @1 © 2013 INIST-CNRS. All rights reserved.
A45       @0 20 ref.
A47 01  1    @0 13-0239401
A60       @1 P
A61       @0 A
A64 01  1    @0 Multiple sclerosis
A66 01      @0 GBR
C01 01    ENG  @0 Background: The placebo-controlled phase of the PreCISe study showed that glatiramer acetate delayed onset of clinically definite multiple sclerosis (CDMS) in patients with clinically isolated syndrome and brain lesions on MRI. Objective: To compare the effects of early versus delayed glatiramer acetate treatment in the open-label phase of PreCISe. Methods: Patients with a clinically isolated syndrome suggestive of MS with unifocal manifestation and ≥2 T2-weighted brain lesions were randomized to receive glatiramer acetate 20 mg/d (early-treatment, n=198) or placebo (delayed-treatment, n=211) for 36 months or until conversion to CDMS, followed by open-label glatiramer acetate treatment for two years. Results: Early glatiramer acetate treatment reduced CDMS conversion risk by 41% (hazard ratio 0.59, 95% confidence interval 0.44-0.80; p=0.0005) versus delayed-treatment, and was associated with a 972-day delay (185%) in conversion to CDMS, less brain atrophy (-28%, p=0.0209), fewer new T2 lesions/year (-42%, <0.0001) and lower T2 lesion volume (-22%, p=0.0005) versus delayed treatment. Adverse events were consistent with the established safety profile of glatiramer acetate. Conclusions: Effects of early glatiramer acetate treatment on the rate of conversion to CDMS and on MRI measures of disease activity and lesion burden support initiating glatiramer acetate treatment soon after the first clinical symptoms suggestive of MS and continuing treatment to sustain benefits.
C02 01  X    @0 002B17G
C02 02  X    @0 002B17F
C03 01  X  FRE  @0 Sclérose en plaques @2 NM @5 01
C03 01  X  ENG  @0 Multiple sclerosis @2 NM @5 01
C03 01  X  SPA  @0 Esclerosis en placa @2 NM @5 01
C03 02  X  FRE  @0 Atrophie @5 02
C03 02  X  ENG  @0 Atrophy @5 02
C03 02  X  SPA  @0 Atrofia @5 02
C03 03  X  FRE  @0 Pathologie du système nerveux @5 03
C03 03  X  ENG  @0 Nervous system diseases @5 03
C03 03  X  SPA  @0 Sistema nervioso patología @5 03
C03 04  X  FRE  @0 Maladie dégénérative @5 04
C03 04  X  ENG  @0 Degenerative disease @5 04
C03 04  X  SPA  @0 Enfermedad degenerativa @5 04
C03 05  X  FRE  @0 Traitement @5 09
C03 05  X  ENG  @0 Treatment @5 09
C03 05  X  SPA  @0 Tratamiento @5 09
C03 06  X  FRE  @0 Homme @5 10
C03 06  X  ENG  @0 Human @5 10
C03 06  X  SPA  @0 Hombre @5 10
C03 07  X  FRE  @0 Encéphale @5 11
C03 07  X  ENG  @0 Encephalon @5 11
C03 07  X  SPA  @0 Encéfalo @5 11
C03 08  X  FRE  @0 Imagerie RMN @5 12
C03 08  X  ENG  @0 Nuclear magnetic resonance imaging @5 12
C03 08  X  SPA  @0 Imaginería RMN @5 12
C03 09  X  FRE  @0 Récidive @5 13
C03 09  X  ENG  @0 Relapse @5 13
C03 09  X  SPA  @0 Recaida @5 13
C03 10  X  FRE  @0 Acétate de glatiramère @4 CD @5 96
C03 10  X  ENG  @0 Glatiramer acetate @4 CD @5 96
C03 10  X  SPA  @0 Acetato de glatiramer @4 CD @5 96
C07 01  X  FRE  @0 Maladie inflammatoire @5 37
C07 01  X  ENG  @0 Inflammatory disease @5 37
C07 01  X  SPA  @0 Enfermedad inflamatoria @5 37
C07 02  X  FRE  @0 Pathologie du système nerveux central @5 38
C07 02  X  ENG  @0 Central nervous system disease @5 38
C07 02  X  SPA  @0 Sistema nervosio central patología @5 38
C07 03  X  FRE  @0 Système nerveux central @5 40
C07 03  X  ENG  @0 Central nervous system @5 40
C07 03  X  SPA  @0 Sistema nervioso central @5 40
N21       @1 224
N44 01      @1 OTO
N82       @1 OTO

Format Inist (serveur)

NO : PASCAL 13-0239401 INIST
ET : Effects of early treatment with glatiramer acetate in patients with clinically isolated syndrome
AU : COMI (Giancarlo); MARTINELLI (Vittorio); RODEGHER (Mariaemma); MOIOLA (Lucia); LEOCANI (Letizia); BAJENARU (Ovidiu); CARRA (Adriana); ELOVAARA (Irina); FAZEKAS (Franz); HARTUNG (Hans-Peter); HILLERT (Jan); KING (John); KOMOLY (Samuel); LUBETZKI (Catherine); MONTALBAN (Xavier); MYHR (Kjell-Morten); PREZIOSA (Paolo); RAVNBORG (Mads); RIECKMANN (Peter); ROCCA (Maria A.); WYNN (Daniel); YOUNG (Carolyn); FILIPPI (Massimo)
AF : Institute of Experimental Neurology, Department of Neurology, University Vita-Salute, Scientific Institute San Raffaele/Milan/Italie (1 aut., 2 aut., 3 aut., 4 aut., 5 aut.); University of Medicine and Pharmacy 'Carol Davila' Bucharest, Department of Neurology, University Hospital of Emergency/Roumanie (6 aut.); Hospital Británico de Buenos Aires/Argentine (7 aut.); University of Tampere, Medical School, Department of Neurology/Finlande (8 aut.); Department of Neurology, Medical University Graz/Autriche (9 aut.); Department of Neurology, Heinrich-Heine-University/Düsseldorf/Allemagne (10 aut.); Huddinge University Hospital, Department of Neurology/Stockholm/Suède (11 aut.); Royal Melbourne Hospital, Department of Neurology/Parkville/Australie (12 aut.); Department of Neurology, University of Pecs/Hongrie (13 aut.); Department of Neurology, Clinical Research Centre, Hôpital Pitié Salpêtrière/Paris/France (14 aut.); Hospital General Universitari Vall d'Hebrón/Barcelona/Espagne (15 aut.); The Norwegian Multiple Sclerosis Competence Centre, Department of Neurology, Haukeland University Hospital/Bergen/Norvège (16 aut.); Institute of Experimental Neurology, Division of Neuroscience, University Vita-Salute and Scientific Institute San Raffaele/Milan/Italie (17 aut., 20 aut., 23 aut.); Department of Neurology, Odense University Hospital/Danemark (18 aut.); Department of Neurology, Academic Hospital Bamberg, University of Erlangen/Allemagne (19 aut.); Consultants in Neurology Multiple Sclerosis Centre, Department of Clinical Research/Northbrook, IL/Etats-Unis (21 aut.); Walton Centre for Neurology and Neurosurgery/Liverpool/Royaume-Uni (22 aut.)
DT : Publication en série; Niveau analytique
SO : Multiple sclerosis; ISSN 1352-4585; Royaume-Uni; Da. 2013; Vol. 19; No. 8; Pp. 1074-1083; Bibl. 20 ref.
LA : Anglais
EA : Background: The placebo-controlled phase of the PreCISe study showed that glatiramer acetate delayed onset of clinically definite multiple sclerosis (CDMS) in patients with clinically isolated syndrome and brain lesions on MRI. Objective: To compare the effects of early versus delayed glatiramer acetate treatment in the open-label phase of PreCISe. Methods: Patients with a clinically isolated syndrome suggestive of MS with unifocal manifestation and ≥2 T2-weighted brain lesions were randomized to receive glatiramer acetate 20 mg/d (early-treatment, n=198) or placebo (delayed-treatment, n=211) for 36 months or until conversion to CDMS, followed by open-label glatiramer acetate treatment for two years. Results: Early glatiramer acetate treatment reduced CDMS conversion risk by 41% (hazard ratio 0.59, 95% confidence interval 0.44-0.80; p=0.0005) versus delayed-treatment, and was associated with a 972-day delay (185%) in conversion to CDMS, less brain atrophy (-28%, p=0.0209), fewer new T2 lesions/year (-42%, <0.0001) and lower T2 lesion volume (-22%, p=0.0005) versus delayed treatment. Adverse events were consistent with the established safety profile of glatiramer acetate. Conclusions: Effects of early glatiramer acetate treatment on the rate of conversion to CDMS and on MRI measures of disease activity and lesion burden support initiating glatiramer acetate treatment soon after the first clinical symptoms suggestive of MS and continuing treatment to sustain benefits.
CC : 002B17G; 002B17F
FD : Sclérose en plaques; Atrophie; Pathologie du système nerveux; Maladie dégénérative; Traitement; Homme; Encéphale; Imagerie RMN; Récidive; Acétate de glatiramère
FG : Maladie inflammatoire; Pathologie du système nerveux central; Système nerveux central
ED : Multiple sclerosis; Atrophy; Nervous system diseases; Degenerative disease; Treatment; Human; Encephalon; Nuclear magnetic resonance imaging; Relapse; Glatiramer acetate
EG : Inflammatory disease; Central nervous system disease; Central nervous system
SD : Esclerosis en placa; Atrofia; Sistema nervioso patología; Enfermedad degenerativa; Tratamiento; Hombre; Encéfalo; Imaginería RMN; Recaida; Acetato de glatiramer
LO : INIST-26577.354000503883140150
ID : 13-0239401

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Pascal:13-0239401

Le document en format XML

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<name sortKey="Moiola, Lucia" sort="Moiola, Lucia" uniqKey="Moiola L" first="Lucia" last="Moiola">Lucia Moiola</name>
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<name sortKey="Leocani, Letizia" sort="Leocani, Letizia" uniqKey="Leocani L" first="Letizia" last="Leocani">Letizia Leocani</name>
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<name sortKey="Elovaara, Irina" sort="Elovaara, Irina" uniqKey="Elovaara I" first="Irina" last="Elovaara">Irina Elovaara</name>
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<name sortKey="Fazekas, Franz" sort="Fazekas, Franz" uniqKey="Fazekas F" first="Franz" last="Fazekas">Franz Fazekas</name>
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<name sortKey="Hartung, Hans Peter" sort="Hartung, Hans Peter" uniqKey="Hartung H" first="Hans-Peter" last="Hartung">Hans-Peter Hartung</name>
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<name sortKey="Hillert, Jan" sort="Hillert, Jan" uniqKey="Hillert J" first="Jan" last="Hillert">Jan Hillert</name>
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<name sortKey="King, John" sort="King, John" uniqKey="King J" first="John" last="King">John King</name>
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<name sortKey="Komoly, Samuel" sort="Komoly, Samuel" uniqKey="Komoly S" first="Samuel" last="Komoly">Samuel Komoly</name>
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<name sortKey="Lubetzki, Catherine" sort="Lubetzki, Catherine" uniqKey="Lubetzki C" first="Catherine" last="Lubetzki">Catherine Lubetzki</name>
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<s1>Department of Neurology, Clinical Research Centre, Hôpital Pitié Salpêtrière</s1>
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<name sortKey="Montalban, Xavier" sort="Montalban, Xavier" uniqKey="Montalban X" first="Xavier" last="Montalban">Xavier Montalban</name>
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<name sortKey="Myhr, Kjell Morten" sort="Myhr, Kjell Morten" uniqKey="Myhr K" first="Kjell-Morten" last="Myhr">Kjell-Morten Myhr</name>
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<inist:fA14 i1="12">
<s1>The Norwegian Multiple Sclerosis Competence Centre, Department of Neurology, Haukeland University Hospital</s1>
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<name sortKey="Preziosa, Paolo" sort="Preziosa, Paolo" uniqKey="Preziosa P" first="Paolo" last="Preziosa">Paolo Preziosa</name>
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<s1>Institute of Experimental Neurology, Division of Neuroscience, University Vita-Salute and Scientific Institute San Raffaele</s1>
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<name sortKey="Ravnborg, Mads" sort="Ravnborg, Mads" uniqKey="Ravnborg M" first="Mads" last="Ravnborg">Mads Ravnborg</name>
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<inist:fA14 i1="14">
<s1>Department of Neurology, Odense University Hospital</s1>
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<name sortKey="Rieckmann, Peter" sort="Rieckmann, Peter" uniqKey="Rieckmann P" first="Peter" last="Rieckmann">Peter Rieckmann</name>
<affiliation>
<inist:fA14 i1="15">
<s1>Department of Neurology, Academic Hospital Bamberg, University of Erlangen</s1>
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</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Rocca, Maria A" sort="Rocca, Maria A" uniqKey="Rocca M" first="Maria A." last="Rocca">Maria A. Rocca</name>
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<s1>Consultants in Neurology Multiple Sclerosis Centre, Department of Clinical Research</s1>
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</inist:fA14>
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<inist:fA14 i1="17">
<s1>Walton Centre for Neurology and Neurosurgery</s1>
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</inist:fA14>
</affiliation>
</author>
<author>
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<sZ>17 aut.</sZ>
<sZ>20 aut.</sZ>
<sZ>23 aut.</sZ>
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<idno type="RBID">Pascal:13-0239401</idno>
<idno type="wicri:Area/PascalFrancis/Corpus">000944</idno>
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<title xml:lang="en" level="a">Effects of early treatment with glatiramer acetate in patients with clinically isolated syndrome</title>
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<name sortKey="Comi, Giancarlo" sort="Comi, Giancarlo" uniqKey="Comi G" first="Giancarlo" last="Comi">Giancarlo Comi</name>
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<inist:fA14 i1="01">
<s1>Institute of Experimental Neurology, Department of Neurology, University Vita-Salute, Scientific Institute San Raffaele</s1>
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<s3>ITA</s3>
<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
<sZ>3 aut.</sZ>
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<author>
<name sortKey="Martinelli, Vittorio" sort="Martinelli, Vittorio" uniqKey="Martinelli V" first="Vittorio" last="Martinelli">Vittorio Martinelli</name>
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<inist:fA14 i1="01">
<s1>Institute of Experimental Neurology, Department of Neurology, University Vita-Salute, Scientific Institute San Raffaele</s1>
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<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
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</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Rodegher, Mariaemma" sort="Rodegher, Mariaemma" uniqKey="Rodegher M" first="Mariaemma" last="Rodegher">Mariaemma Rodegher</name>
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<inist:fA14 i1="01">
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<sZ>1 aut.</sZ>
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</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Moiola, Lucia" sort="Moiola, Lucia" uniqKey="Moiola L" first="Lucia" last="Moiola">Lucia Moiola</name>
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<inist:fA14 i1="01">
<s1>Institute of Experimental Neurology, Department of Neurology, University Vita-Salute, Scientific Institute San Raffaele</s1>
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<sZ>1 aut.</sZ>
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<sZ>3 aut.</sZ>
<sZ>4 aut.</sZ>
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</inist:fA14>
</affiliation>
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<author>
<name sortKey="Leocani, Letizia" sort="Leocani, Letizia" uniqKey="Leocani L" first="Letizia" last="Leocani">Letizia Leocani</name>
<affiliation>
<inist:fA14 i1="01">
<s1>Institute of Experimental Neurology, Department of Neurology, University Vita-Salute, Scientific Institute San Raffaele</s1>
<s2>Milan</s2>
<s3>ITA</s3>
<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
<sZ>3 aut.</sZ>
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</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Bajenaru, Ovidiu" sort="Bajenaru, Ovidiu" uniqKey="Bajenaru O" first="Ovidiu" last="Bajenaru">Ovidiu Bajenaru</name>
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<inist:fA14 i1="02">
<s1>University of Medicine and Pharmacy 'Carol Davila' Bucharest, Department of Neurology, University Hospital of Emergency</s1>
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<sZ>6 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Carra, Adriana" sort="Carra, Adriana" uniqKey="Carra A" first="Adriana" last="Carra">Adriana Carra</name>
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<inist:fA14 i1="03">
<s1>Hospital Británico de Buenos Aires</s1>
<s3>ARG</s3>
<sZ>7 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Elovaara, Irina" sort="Elovaara, Irina" uniqKey="Elovaara I" first="Irina" last="Elovaara">Irina Elovaara</name>
<affiliation>
<inist:fA14 i1="04">
<s1>University of Tampere, Medical School, Department of Neurology</s1>
<s3>FIN</s3>
<sZ>8 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Fazekas, Franz" sort="Fazekas, Franz" uniqKey="Fazekas F" first="Franz" last="Fazekas">Franz Fazekas</name>
<affiliation>
<inist:fA14 i1="05">
<s1>Department of Neurology, Medical University Graz</s1>
<s3>AUT</s3>
<sZ>9 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Hartung, Hans Peter" sort="Hartung, Hans Peter" uniqKey="Hartung H" first="Hans-Peter" last="Hartung">Hans-Peter Hartung</name>
<affiliation>
<inist:fA14 i1="06">
<s1>Department of Neurology, Heinrich-Heine-University</s1>
<s2>Düsseldorf</s2>
<s3>DEU</s3>
<sZ>10 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Hillert, Jan" sort="Hillert, Jan" uniqKey="Hillert J" first="Jan" last="Hillert">Jan Hillert</name>
<affiliation>
<inist:fA14 i1="07">
<s1>Huddinge University Hospital, Department of Neurology</s1>
<s2>Stockholm</s2>
<s3>SWE</s3>
<sZ>11 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="King, John" sort="King, John" uniqKey="King J" first="John" last="King">John King</name>
<affiliation>
<inist:fA14 i1="08">
<s1>Royal Melbourne Hospital, Department of Neurology</s1>
<s2>Parkville</s2>
<s3>AUS</s3>
<sZ>12 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Komoly, Samuel" sort="Komoly, Samuel" uniqKey="Komoly S" first="Samuel" last="Komoly">Samuel Komoly</name>
<affiliation>
<inist:fA14 i1="09">
<s1>Department of Neurology, University of Pecs</s1>
<s3>HUN</s3>
<sZ>13 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Lubetzki, Catherine" sort="Lubetzki, Catherine" uniqKey="Lubetzki C" first="Catherine" last="Lubetzki">Catherine Lubetzki</name>
<affiliation>
<inist:fA14 i1="10">
<s1>Department of Neurology, Clinical Research Centre, Hôpital Pitié Salpêtrière</s1>
<s2>Paris</s2>
<s3>FRA</s3>
<sZ>14 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Montalban, Xavier" sort="Montalban, Xavier" uniqKey="Montalban X" first="Xavier" last="Montalban">Xavier Montalban</name>
<affiliation>
<inist:fA14 i1="11">
<s1>Hospital General Universitari Vall d'Hebrón</s1>
<s2>Barcelona</s2>
<s3>ESP</s3>
<sZ>15 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Myhr, Kjell Morten" sort="Myhr, Kjell Morten" uniqKey="Myhr K" first="Kjell-Morten" last="Myhr">Kjell-Morten Myhr</name>
<affiliation>
<inist:fA14 i1="12">
<s1>The Norwegian Multiple Sclerosis Competence Centre, Department of Neurology, Haukeland University Hospital</s1>
<s2>Bergen</s2>
<s3>NOR</s3>
<sZ>16 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Preziosa, Paolo" sort="Preziosa, Paolo" uniqKey="Preziosa P" first="Paolo" last="Preziosa">Paolo Preziosa</name>
<affiliation>
<inist:fA14 i1="13">
<s1>Institute of Experimental Neurology, Division of Neuroscience, University Vita-Salute and Scientific Institute San Raffaele</s1>
<s2>Milan</s2>
<s3>ITA</s3>
<sZ>17 aut.</sZ>
<sZ>20 aut.</sZ>
<sZ>23 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Ravnborg, Mads" sort="Ravnborg, Mads" uniqKey="Ravnborg M" first="Mads" last="Ravnborg">Mads Ravnborg</name>
<affiliation>
<inist:fA14 i1="14">
<s1>Department of Neurology, Odense University Hospital</s1>
<s3>DNK</s3>
<sZ>18 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Rieckmann, Peter" sort="Rieckmann, Peter" uniqKey="Rieckmann P" first="Peter" last="Rieckmann">Peter Rieckmann</name>
<affiliation>
<inist:fA14 i1="15">
<s1>Department of Neurology, Academic Hospital Bamberg, University of Erlangen</s1>
<s3>DEU</s3>
<sZ>19 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Rocca, Maria A" sort="Rocca, Maria A" uniqKey="Rocca M" first="Maria A." last="Rocca">Maria A. Rocca</name>
<affiliation>
<inist:fA14 i1="13">
<s1>Institute of Experimental Neurology, Division of Neuroscience, University Vita-Salute and Scientific Institute San Raffaele</s1>
<s2>Milan</s2>
<s3>ITA</s3>
<sZ>17 aut.</sZ>
<sZ>20 aut.</sZ>
<sZ>23 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Wynn, Daniel" sort="Wynn, Daniel" uniqKey="Wynn D" first="Daniel" last="Wynn">Daniel Wynn</name>
<affiliation>
<inist:fA14 i1="16">
<s1>Consultants in Neurology Multiple Sclerosis Centre, Department of Clinical Research</s1>
<s2>Northbrook, IL</s2>
<s3>USA</s3>
<sZ>21 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Young, Carolyn" sort="Young, Carolyn" uniqKey="Young C" first="Carolyn" last="Young">Carolyn Young</name>
<affiliation>
<inist:fA14 i1="17">
<s1>Walton Centre for Neurology and Neurosurgery</s1>
<s2>Liverpool</s2>
<s3>GBR</s3>
<sZ>22 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Filippi, Massimo" sort="Filippi, Massimo" uniqKey="Filippi M" first="Massimo" last="Filippi">Massimo Filippi</name>
<affiliation>
<inist:fA14 i1="13">
<s1>Institute of Experimental Neurology, Division of Neuroscience, University Vita-Salute and Scientific Institute San Raffaele</s1>
<s2>Milan</s2>
<s3>ITA</s3>
<sZ>17 aut.</sZ>
<sZ>20 aut.</sZ>
<sZ>23 aut.</sZ>
</inist:fA14>
</affiliation>
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<series>
<title level="j" type="main">Multiple sclerosis</title>
<title level="j" type="abbreviated">Mult. scler.</title>
<idno type="ISSN">1352-4585</idno>
<imprint>
<date when="2013">2013</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
<seriesStmt>
<title level="j" type="main">Multiple sclerosis</title>
<title level="j" type="abbreviated">Mult. scler.</title>
<idno type="ISSN">1352-4585</idno>
</seriesStmt>
</fileDesc>
<profileDesc>
<textClass>
<keywords scheme="KwdEn" xml:lang="en">
<term>Atrophy</term>
<term>Degenerative disease</term>
<term>Encephalon</term>
<term>Glatiramer acetate</term>
<term>Human</term>
<term>Multiple sclerosis</term>
<term>Nervous system diseases</term>
<term>Nuclear magnetic resonance imaging</term>
<term>Relapse</term>
<term>Treatment</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr">
<term>Sclérose en plaques</term>
<term>Atrophie</term>
<term>Pathologie du système nerveux</term>
<term>Maladie dégénérative</term>
<term>Traitement</term>
<term>Homme</term>
<term>Encéphale</term>
<term>Imagerie RMN</term>
<term>Récidive</term>
<term>Acétate de glatiramère</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front>
<div type="abstract" xml:lang="en">Background: The placebo-controlled phase of the PreCISe study showed that glatiramer acetate delayed onset of clinically definite multiple sclerosis (CDMS) in patients with clinically isolated syndrome and brain lesions on MRI. Objective: To compare the effects of early versus delayed glatiramer acetate treatment in the open-label phase of PreCISe. Methods: Patients with a clinically isolated syndrome suggestive of MS with unifocal manifestation and ≥2 T2-weighted brain lesions were randomized to receive glatiramer acetate 20 mg/d (early-treatment, n=198) or placebo (delayed-treatment, n=211) for 36 months or until conversion to CDMS, followed by open-label glatiramer acetate treatment for two years. Results: Early glatiramer acetate treatment reduced CDMS conversion risk by 41% (hazard ratio 0.59, 95% confidence interval 0.44-0.80; p=0.0005) versus delayed-treatment, and was associated with a 972-day delay (185%) in conversion to CDMS, less brain atrophy (-28%, p=0.0209), fewer new T2 lesions/year (-42%, <0.0001) and lower T2 lesion volume (-22%, p=0.0005) versus delayed treatment. Adverse events were consistent with the established safety profile of glatiramer acetate. Conclusions: Effects of early glatiramer acetate treatment on the rate of conversion to CDMS and on MRI measures of disease activity and lesion burden support initiating glatiramer acetate treatment soon after the first clinical symptoms suggestive of MS and continuing treatment to sustain benefits.</div>
</front>
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<s1>Department of Neurology, Medical University Graz</s1>
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<s1>Department of Neurology, Heinrich-Heine-University</s1>
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<s1>Huddinge University Hospital, Department of Neurology</s1>
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<s1>Royal Melbourne Hospital, Department of Neurology</s1>
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<s1>Department of Neurology, Clinical Research Centre, Hôpital Pitié Salpêtrière</s1>
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<s3>FRA</s3>
<sZ>14 aut.</sZ>
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<s1>Hospital General Universitari Vall d'Hebrón</s1>
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<s3>ESP</s3>
<sZ>15 aut.</sZ>
</fA14>
<fA14 i1="12">
<s1>The Norwegian Multiple Sclerosis Competence Centre, Department of Neurology, Haukeland University Hospital</s1>
<s2>Bergen</s2>
<s3>NOR</s3>
<sZ>16 aut.</sZ>
</fA14>
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<s1>Institute of Experimental Neurology, Division of Neuroscience, University Vita-Salute and Scientific Institute San Raffaele</s1>
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<sZ>17 aut.</sZ>
<sZ>20 aut.</sZ>
<sZ>23 aut.</sZ>
</fA14>
<fA14 i1="14">
<s1>Department of Neurology, Odense University Hospital</s1>
<s3>DNK</s3>
<sZ>18 aut.</sZ>
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<s1>Department of Neurology, Academic Hospital Bamberg, University of Erlangen</s1>
<s3>DEU</s3>
<sZ>19 aut.</sZ>
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<fA14 i1="16">
<s1>Consultants in Neurology Multiple Sclerosis Centre, Department of Clinical Research</s1>
<s2>Northbrook, IL</s2>
<s3>USA</s3>
<sZ>21 aut.</sZ>
</fA14>
<fA14 i1="17">
<s1>Walton Centre for Neurology and Neurosurgery</s1>
<s2>Liverpool</s2>
<s3>GBR</s3>
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<s1>© 2013 INIST-CNRS. All rights reserved.</s1>
</fA44>
<fA45>
<s0>20 ref.</s0>
</fA45>
<fA47 i1="01" i2="1">
<s0>13-0239401</s0>
</fA47>
<fA60>
<s1>P</s1>
</fA60>
<fA61>
<s0>A</s0>
</fA61>
<fA64 i1="01" i2="1">
<s0>Multiple sclerosis</s0>
</fA64>
<fA66 i1="01">
<s0>GBR</s0>
</fA66>
<fC01 i1="01" l="ENG">
<s0>Background: The placebo-controlled phase of the PreCISe study showed that glatiramer acetate delayed onset of clinically definite multiple sclerosis (CDMS) in patients with clinically isolated syndrome and brain lesions on MRI. Objective: To compare the effects of early versus delayed glatiramer acetate treatment in the open-label phase of PreCISe. Methods: Patients with a clinically isolated syndrome suggestive of MS with unifocal manifestation and ≥2 T2-weighted brain lesions were randomized to receive glatiramer acetate 20 mg/d (early-treatment, n=198) or placebo (delayed-treatment, n=211) for 36 months or until conversion to CDMS, followed by open-label glatiramer acetate treatment for two years. Results: Early glatiramer acetate treatment reduced CDMS conversion risk by 41% (hazard ratio 0.59, 95% confidence interval 0.44-0.80; p=0.0005) versus delayed-treatment, and was associated with a 972-day delay (185%) in conversion to CDMS, less brain atrophy (-28%, p=0.0209), fewer new T2 lesions/year (-42%, <0.0001) and lower T2 lesion volume (-22%, p=0.0005) versus delayed treatment. Adverse events were consistent with the established safety profile of glatiramer acetate. Conclusions: Effects of early glatiramer acetate treatment on the rate of conversion to CDMS and on MRI measures of disease activity and lesion burden support initiating glatiramer acetate treatment soon after the first clinical symptoms suggestive of MS and continuing treatment to sustain benefits.</s0>
</fC01>
<fC02 i1="01" i2="X">
<s0>002B17G</s0>
</fC02>
<fC02 i1="02" i2="X">
<s0>002B17F</s0>
</fC02>
<fC03 i1="01" i2="X" l="FRE">
<s0>Sclérose en plaques</s0>
<s2>NM</s2>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="ENG">
<s0>Multiple sclerosis</s0>
<s2>NM</s2>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="SPA">
<s0>Esclerosis en placa</s0>
<s2>NM</s2>
<s5>01</s5>
</fC03>
<fC03 i1="02" i2="X" l="FRE">
<s0>Atrophie</s0>
<s5>02</s5>
</fC03>
<fC03 i1="02" i2="X" l="ENG">
<s0>Atrophy</s0>
<s5>02</s5>
</fC03>
<fC03 i1="02" i2="X" l="SPA">
<s0>Atrofia</s0>
<s5>02</s5>
</fC03>
<fC03 i1="03" i2="X" l="FRE">
<s0>Pathologie du système nerveux</s0>
<s5>03</s5>
</fC03>
<fC03 i1="03" i2="X" l="ENG">
<s0>Nervous system diseases</s0>
<s5>03</s5>
</fC03>
<fC03 i1="03" i2="X" l="SPA">
<s0>Sistema nervioso patología</s0>
<s5>03</s5>
</fC03>
<fC03 i1="04" i2="X" l="FRE">
<s0>Maladie dégénérative</s0>
<s5>04</s5>
</fC03>
<fC03 i1="04" i2="X" l="ENG">
<s0>Degenerative disease</s0>
<s5>04</s5>
</fC03>
<fC03 i1="04" i2="X" l="SPA">
<s0>Enfermedad degenerativa</s0>
<s5>04</s5>
</fC03>
<fC03 i1="05" i2="X" l="FRE">
<s0>Traitement</s0>
<s5>09</s5>
</fC03>
<fC03 i1="05" i2="X" l="ENG">
<s0>Treatment</s0>
<s5>09</s5>
</fC03>
<fC03 i1="05" i2="X" l="SPA">
<s0>Tratamiento</s0>
<s5>09</s5>
</fC03>
<fC03 i1="06" i2="X" l="FRE">
<s0>Homme</s0>
<s5>10</s5>
</fC03>
<fC03 i1="06" i2="X" l="ENG">
<s0>Human</s0>
<s5>10</s5>
</fC03>
<fC03 i1="06" i2="X" l="SPA">
<s0>Hombre</s0>
<s5>10</s5>
</fC03>
<fC03 i1="07" i2="X" l="FRE">
<s0>Encéphale</s0>
<s5>11</s5>
</fC03>
<fC03 i1="07" i2="X" l="ENG">
<s0>Encephalon</s0>
<s5>11</s5>
</fC03>
<fC03 i1="07" i2="X" l="SPA">
<s0>Encéfalo</s0>
<s5>11</s5>
</fC03>
<fC03 i1="08" i2="X" l="FRE">
<s0>Imagerie RMN</s0>
<s5>12</s5>
</fC03>
<fC03 i1="08" i2="X" l="ENG">
<s0>Nuclear magnetic resonance imaging</s0>
<s5>12</s5>
</fC03>
<fC03 i1="08" i2="X" l="SPA">
<s0>Imaginería RMN</s0>
<s5>12</s5>
</fC03>
<fC03 i1="09" i2="X" l="FRE">
<s0>Récidive</s0>
<s5>13</s5>
</fC03>
<fC03 i1="09" i2="X" l="ENG">
<s0>Relapse</s0>
<s5>13</s5>
</fC03>
<fC03 i1="09" i2="X" l="SPA">
<s0>Recaida</s0>
<s5>13</s5>
</fC03>
<fC03 i1="10" i2="X" l="FRE">
<s0>Acétate de glatiramère</s0>
<s4>CD</s4>
<s5>96</s5>
</fC03>
<fC03 i1="10" i2="X" l="ENG">
<s0>Glatiramer acetate</s0>
<s4>CD</s4>
<s5>96</s5>
</fC03>
<fC03 i1="10" i2="X" l="SPA">
<s0>Acetato de glatiramer</s0>
<s4>CD</s4>
<s5>96</s5>
</fC03>
<fC07 i1="01" i2="X" l="FRE">
<s0>Maladie inflammatoire</s0>
<s5>37</s5>
</fC07>
<fC07 i1="01" i2="X" l="ENG">
<s0>Inflammatory disease</s0>
<s5>37</s5>
</fC07>
<fC07 i1="01" i2="X" l="SPA">
<s0>Enfermedad inflamatoria</s0>
<s5>37</s5>
</fC07>
<fC07 i1="02" i2="X" l="FRE">
<s0>Pathologie du système nerveux central</s0>
<s5>38</s5>
</fC07>
<fC07 i1="02" i2="X" l="ENG">
<s0>Central nervous system disease</s0>
<s5>38</s5>
</fC07>
<fC07 i1="02" i2="X" l="SPA">
<s0>Sistema nervosio central patología</s0>
<s5>38</s5>
</fC07>
<fC07 i1="03" i2="X" l="FRE">
<s0>Système nerveux central</s0>
<s5>40</s5>
</fC07>
<fC07 i1="03" i2="X" l="ENG">
<s0>Central nervous system</s0>
<s5>40</s5>
</fC07>
<fC07 i1="03" i2="X" l="SPA">
<s0>Sistema nervioso central</s0>
<s5>40</s5>
</fC07>
<fN21>
<s1>224</s1>
</fN21>
<fN44 i1="01">
<s1>OTO</s1>
</fN44>
<fN82>
<s1>OTO</s1>
</fN82>
</pA>
</standard>
<server>
<NO>PASCAL 13-0239401 INIST</NO>
<ET>Effects of early treatment with glatiramer acetate in patients with clinically isolated syndrome</ET>
<AU>COMI (Giancarlo); MARTINELLI (Vittorio); RODEGHER (Mariaemma); MOIOLA (Lucia); LEOCANI (Letizia); BAJENARU (Ovidiu); CARRA (Adriana); ELOVAARA (Irina); FAZEKAS (Franz); HARTUNG (Hans-Peter); HILLERT (Jan); KING (John); KOMOLY (Samuel); LUBETZKI (Catherine); MONTALBAN (Xavier); MYHR (Kjell-Morten); PREZIOSA (Paolo); RAVNBORG (Mads); RIECKMANN (Peter); ROCCA (Maria A.); WYNN (Daniel); YOUNG (Carolyn); FILIPPI (Massimo)</AU>
<AF>Institute of Experimental Neurology, Department of Neurology, University Vita-Salute, Scientific Institute San Raffaele/Milan/Italie (1 aut., 2 aut., 3 aut., 4 aut., 5 aut.); University of Medicine and Pharmacy 'Carol Davila' Bucharest, Department of Neurology, University Hospital of Emergency/Roumanie (6 aut.); Hospital Británico de Buenos Aires/Argentine (7 aut.); University of Tampere, Medical School, Department of Neurology/Finlande (8 aut.); Department of Neurology, Medical University Graz/Autriche (9 aut.); Department of Neurology, Heinrich-Heine-University/Düsseldorf/Allemagne (10 aut.); Huddinge University Hospital, Department of Neurology/Stockholm/Suède (11 aut.); Royal Melbourne Hospital, Department of Neurology/Parkville/Australie (12 aut.); Department of Neurology, University of Pecs/Hongrie (13 aut.); Department of Neurology, Clinical Research Centre, Hôpital Pitié Salpêtrière/Paris/France (14 aut.); Hospital General Universitari Vall d'Hebrón/Barcelona/Espagne (15 aut.); The Norwegian Multiple Sclerosis Competence Centre, Department of Neurology, Haukeland University Hospital/Bergen/Norvège (16 aut.); Institute of Experimental Neurology, Division of Neuroscience, University Vita-Salute and Scientific Institute San Raffaele/Milan/Italie (17 aut., 20 aut., 23 aut.); Department of Neurology, Odense University Hospital/Danemark (18 aut.); Department of Neurology, Academic Hospital Bamberg, University of Erlangen/Allemagne (19 aut.); Consultants in Neurology Multiple Sclerosis Centre, Department of Clinical Research/Northbrook, IL/Etats-Unis (21 aut.); Walton Centre for Neurology and Neurosurgery/Liverpool/Royaume-Uni (22 aut.)</AF>
<DT>Publication en série; Niveau analytique</DT>
<SO>Multiple sclerosis; ISSN 1352-4585; Royaume-Uni; Da. 2013; Vol. 19; No. 8; Pp. 1074-1083; Bibl. 20 ref.</SO>
<LA>Anglais</LA>
<EA>Background: The placebo-controlled phase of the PreCISe study showed that glatiramer acetate delayed onset of clinically definite multiple sclerosis (CDMS) in patients with clinically isolated syndrome and brain lesions on MRI. Objective: To compare the effects of early versus delayed glatiramer acetate treatment in the open-label phase of PreCISe. Methods: Patients with a clinically isolated syndrome suggestive of MS with unifocal manifestation and ≥2 T2-weighted brain lesions were randomized to receive glatiramer acetate 20 mg/d (early-treatment, n=198) or placebo (delayed-treatment, n=211) for 36 months or until conversion to CDMS, followed by open-label glatiramer acetate treatment for two years. Results: Early glatiramer acetate treatment reduced CDMS conversion risk by 41% (hazard ratio 0.59, 95% confidence interval 0.44-0.80; p=0.0005) versus delayed-treatment, and was associated with a 972-day delay (185%) in conversion to CDMS, less brain atrophy (-28%, p=0.0209), fewer new T2 lesions/year (-42%, <0.0001) and lower T2 lesion volume (-22%, p=0.0005) versus delayed treatment. Adverse events were consistent with the established safety profile of glatiramer acetate. Conclusions: Effects of early glatiramer acetate treatment on the rate of conversion to CDMS and on MRI measures of disease activity and lesion burden support initiating glatiramer acetate treatment soon after the first clinical symptoms suggestive of MS and continuing treatment to sustain benefits.</EA>
<CC>002B17G; 002B17F</CC>
<FD>Sclérose en plaques; Atrophie; Pathologie du système nerveux; Maladie dégénérative; Traitement; Homme; Encéphale; Imagerie RMN; Récidive; Acétate de glatiramère</FD>
<FG>Maladie inflammatoire; Pathologie du système nerveux central; Système nerveux central</FG>
<ED>Multiple sclerosis; Atrophy; Nervous system diseases; Degenerative disease; Treatment; Human; Encephalon; Nuclear magnetic resonance imaging; Relapse; Glatiramer acetate</ED>
<EG>Inflammatory disease; Central nervous system disease; Central nervous system</EG>
<SD>Esclerosis en placa; Atrofia; Sistema nervioso patología; Enfermedad degenerativa; Tratamiento; Hombre; Encéfalo; Imaginería RMN; Recaida; Acetato de glatiramer</SD>
<LO>INIST-26577.354000503883140150</LO>
<ID>13-0239401</ID>
</server>
</inist>
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