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Validation of diagnostic magnetic resonance imaging criteria for multiple sclerosis and response to interferon β1a

Identifieur interne : 004D47 ( PascalFrancis/Checkpoint ); précédent : 004D46; suivant : 004D48

Validation of diagnostic magnetic resonance imaging criteria for multiple sclerosis and response to interferon β1a

Auteurs : Frederik Barkhof [Pays-Bas] ; Mara Rocca [Italie] ; Gordon Francis [États-Unis] ; Jan-Hein T. M. Van Waesberghe [Pays-Bas] ; Bernard M. J. Uitdehaag [Pays-Bas] ; Otto R. Hommes [Pays-Bas] ; Hans-Peter Hartung [Autriche] ; Luca Durelli [Italie] ; Gilles Edan [France] ; Oscar Fernandez [Espagne] ; Pierette Seeldrayers [Belgique] ; Per S Rensen [Danemark] ; Simon Margrie [Australie] ; Marco Rovaris [Italie] ; Giancarlo Comi [Italie] ; Massimo Filippi [Italie]

Source :

RBID : Pascal:03-0451872

Descripteurs français

English descriptors

Abstract

In the recently proposed diagnostic criteria for multiple sclerosis (MS) by McDonald, the modified magnetic resonance imaging (MRI) Barkhof criteria have been incorporated. We examined the validity of this implementation in the Early Treatment of MS study, a randomized, double-blind, placebo-controlled study of 22μg interferon β1a given subcutaneously once weekly in 309 patients with a first episode consistent with demyelinating disease (and abnormal MRI). Conversion to clinically definite MS (CDMS) within 2 years of follow-up, as evidenced by a new clinical episode, occurred in 41% of patients (independent of treatment) with gadolinium enhancement or nine or more T2 lesions versus 11% of those without either finding (p = 0.017); similarly, proportions converting were 44% versus 31% for infratentorial lesions (p = 0.026), 40% versus 35% for juxtacortical lesions (p = 0.413), and 41% versus 17% for three or more periventricular lesions (p = 0.034). The rate of conversion to CDMS based on the number of modified Barkhof criteria was 22% for two or fewer positive criteria, increasing to 47% with four positive criteria. For a cutoff of three positive criteria, the hazard ratio for time to CDMS was 2.3 (95% confidence interval, 1.17-4.55; p = 0.016). Treatment effect seemed more evident as the number of positive criteria increased, and the number of patients needed to avoid one patient converting to CDMS decreased from 50 in patients with one or two positive criteria to 5.6 in patients with four positive criteria. However, the study was not powered to detect statistically significant treatment by variable interaction, and this remains an important issue for further study.


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Pascal:03-0451872

Le document en format XML

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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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<name sortKey="Filippi, Massimo" sort="Filippi, Massimo" uniqKey="Filippi M" first="Massimo" last="Filippi">Massimo Filippi</name>
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<title xml:lang="en" level="a">Validation of diagnostic magnetic resonance imaging criteria for multiple sclerosis and response to interferon β1a</title>
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<name sortKey="Barkhof, Frederik" sort="Barkhof, Frederik" uniqKey="Barkhof F" first="Frederik" last="Barkhof">Frederik Barkhof</name>
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<name sortKey="Rocca, Mara" sort="Rocca, Mara" uniqKey="Rocca M" first="Mara" last="Rocca">Mara Rocca</name>
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<name sortKey="Francis, Gordon" sort="Francis, Gordon" uniqKey="Francis G" first="Gordon" last="Francis">Gordon Francis</name>
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<wicri:noRegion>Serono Laboratories</wicri:noRegion>
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<name sortKey="Van Waesberghe, Jan Hein T M" sort="Van Waesberghe, Jan Hein T M" uniqKey="Van Waesberghe J" first="Jan-Hein T. M." last="Van Waesberghe">Jan-Hein T. M. Van Waesberghe</name>
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<s1>MS-MRI Centre and Department of Radiology, VU Medical Centre</s1>
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<name sortKey="Uitdehaag, Bernard M J" sort="Uitdehaag, Bernard M J" uniqKey="Uitdehaag B" first="Bernard M. J." last="Uitdehaag">Bernard M. J. Uitdehaag</name>
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<name sortKey="Hommes, Otto R" sort="Hommes, Otto R" uniqKey="Hommes O" first="Otto R." last="Hommes">Otto R. Hommes</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="Durelli, Luca" sort="Durelli, Luca" uniqKey="Durelli L" first="Luca" last="Durelli">Luca Durelli</name>
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<name sortKey="Edan, Gilles" sort="Edan, Gilles" uniqKey="Edan G" first="Gilles" last="Edan">Gilles Edan</name>
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<name sortKey="Fernandez, Oscar" sort="Fernandez, Oscar" uniqKey="Fernandez O" first="Oscar" last="Fernandez">Oscar Fernandez</name>
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<name sortKey="Seeldrayers, Pierette" sort="Seeldrayers, Pierette" uniqKey="Seeldrayers P" first="Pierette" last="Seeldrayers">Pierette Seeldrayers</name>
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<s1>Department of Neurology, C.H.U. de Charleroi, and Hôpital Erasme</s1>
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<s3>BEL</s3>
<sZ>11 aut.</sZ>
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<name sortKey="S Rensen, Per" sort="S Rensen, Per" uniqKey="S Rensen P" first="Per" last="S Rensen">Per S Rensen</name>
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<s1>Department of Neurology, Rigshospitalet</s1>
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<s3>DNK</s3>
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</inist:fA14>
<country>Danemark</country>
<placeName>
<settlement type="city">Copenhague</settlement>
<region type="région" nuts="2">Hovedstaden</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Margrie, Simon" sort="Margrie, Simon" uniqKey="Margrie S" first="Simon" last="Margrie">Simon Margrie</name>
<affiliation wicri:level="3">
<inist:fA14 i1="12">
<s1>Quintiles Pty Limited</s1>
<s2>Sydney</s2>
<s3>AUS</s3>
<sZ>13 aut.</sZ>
</inist:fA14>
<country>Australie</country>
<placeName>
<settlement type="city">Sydney</settlement>
<region type="état">Nouvelle-Galles du Sud</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Rovaris, Marco" sort="Rovaris, Marco" uniqKey="Rovaris M" first="Marco" last="Rovaris">Marco Rovaris</name>
<affiliation wicri:level="3">
<inist:fA14 i1="02">
<s1>Neuroimaging Research Unit, Department of Neuroscience, IRCCS San Raffaele</s1>
<s2>Milan</s2>
<s3>ITA</s3>
<sZ>2 aut.</sZ>
<sZ>14 aut.</sZ>
<sZ>16 aut.</sZ>
</inist:fA14>
<country>Italie</country>
<placeName>
<settlement type="city">Milan</settlement>
<region nuts="2">Lombardie</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Comi, Giancarlo" sort="Comi, Giancarlo" uniqKey="Comi G" first="Giancarlo" last="Comi">Giancarlo Comi</name>
<affiliation wicri:level="3">
<inist:fA14 i1="13">
<s1>MS Centre, Department of Neuroscience, IRCCS San Raffaele</s1>
<s2>Milan</s2>
<s3>ITA</s3>
<sZ>15 aut.</sZ>
</inist:fA14>
<country>Italie</country>
<placeName>
<settlement type="city">Milan</settlement>
<region nuts="2">Lombardie</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Filippi, Massimo" sort="Filippi, Massimo" uniqKey="Filippi M" first="Massimo" last="Filippi">Massimo Filippi</name>
<affiliation wicri:level="3">
<inist:fA14 i1="02">
<s1>Neuroimaging Research Unit, Department of Neuroscience, IRCCS San Raffaele</s1>
<s2>Milan</s2>
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<div type="abstract" xml:lang="en">In the recently proposed diagnostic criteria for multiple sclerosis (MS) by McDonald, the modified magnetic resonance imaging (MRI) Barkhof criteria have been incorporated. We examined the validity of this implementation in the Early Treatment of MS study, a randomized, double-blind, placebo-controlled study of 22μg interferon β1a given subcutaneously once weekly in 309 patients with a first episode consistent with demyelinating disease (and abnormal MRI). Conversion to clinically definite MS (CDMS) within 2 years of follow-up, as evidenced by a new clinical episode, occurred in 41% of patients (independent of treatment) with gadolinium enhancement or nine or more T2 lesions versus 11% of those without either finding (p = 0.017); similarly, proportions converting were 44% versus 31% for infratentorial lesions (p = 0.026), 40% versus 35% for juxtacortical lesions (p = 0.413), and 41% versus 17% for three or more periventricular lesions (p = 0.034). The rate of conversion to CDMS based on the number of modified Barkhof criteria was 22% for two or fewer positive criteria, increasing to 47% with four positive criteria. For a cutoff of three positive criteria, the hazard ratio for time to CDMS was 2.3 (95% confidence interval, 1.17-4.55; p = 0.016). Treatment effect seemed more evident as the number of positive criteria increased, and the number of patients needed to avoid one patient converting to CDMS decreased from 50 in patients with one or two positive criteria to 5.6 in patients with four positive criteria. However, the study was not powered to detect statistically significant treatment by variable interaction, and this remains an important issue for further study.</div>
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