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American College of Rheumatology/European League Against Rheumatism Provisional Definition of Remission in Rheumatoid Arthritis for Clinical Trials

Identifieur interne : 006D49 ( Main/Exploration ); précédent : 006D48; suivant : 006D50

American College of Rheumatology/European League Against Rheumatism Provisional Definition of Remission in Rheumatoid Arthritis for Clinical Trials

Auteurs : David T. Felson [Italie] ; Josef S. Smolen [Royaume-Uni, Autriche] ; George Wells [Canada] ; BIN ZHANG [États-Unis] ; Lilian H. D. Van Tuyl [Pays-Bas] ; Julia Funovits [Autriche] ; Daniel Aletaha [Autriche] ; Cornelia F. Allaart [Pays-Bas] ; Joan Bathon [États-Unis] ; Stefano Bombardieri [Italie] ; Peter Brooks [Australie] ; Andrew Brown [Royaume-Uni] ; Marco Matucci-Cerinic [Italie] ; Hyon Choi [États-Unis] ; Bernard Combe [France] ; Maarten De Wit [Royaume-Uni] ; Maxime Dougados [France] ; Paul Emery [Royaume-Uni] ; Daniel Furst [États-Unis] ; Juan Gomez-Reino [Espagne] ; Gillian Hawker ; Edward Keystone ; Dinesh Khanna [États-Unis] ; John Kirwan ; Tore K. Kvien ; Robert Landewe ; Joachim Listing ; Kaleb Michaud ; Emilio Martin-Mola ; Pamela Montie ; Theodore Pincus ; Pamela Richards ; Jeffrey N. Siegel ; Lee S. Simon ; Tuulikki Sokka ; Vibeke Strand ; Peter Tugwell [Canada] ; Alan Tyndall ; Desirée Van Der Heijde [Pays-Bas] ; Suzan Verstappen ; Barbara White ; Frederick Wolfe ; Angela Zink ; Maarten Boers [Pays-Bas]

Source :

RBID : Pascal:11-0199749

Descripteurs français

English descriptors

Abstract

Objective. Remission in rheumatoid arthritis (RA) is an increasingly attainable goal, but there is no widely used definition of remission that is stringent but achievable and could be applied uniformly as an outcome measure in clinical trials. This work was undertaken to develop such a definition. Methods. A committee consisting of members of the American College of Rheumatology, the European League Against Rheumatism, and the Outcome Measures in Rheumatology Initiative met to guide the process and review prespecified analyses from RA clinical trials. The committee requested a stringent definition (little, if any, active disease) and decided to use core set measures including, as a minimum, joint counts and levels of an acute-phase reactant to define remission. Members were surveyed to select the level of each core set measure that would be consistent with remission. Candidate definitions of remission were tested, including those that constituted a number of individual measures of remission (Boolean approach) as well as definitions using disease activity indexes. To select a definition of remission, trial data were analyzed to examine the added contribution of patient-reported outcomes and the ability of candidate measures to predict later good radiographic and functional outcomes. Results. Survey results for the definition of remission suggested indexes at published thresholds and a count of core set measures, with each measure scored as 1 or less (e.g., tender and swollen joint counts, C-reactive protein [CRP] level, and global assessments on a 0-10 scale). Analyses suggested the need to include a patient-reported measure. Examination of 2-year followup data suggested that many candidate definitions performed comparably in terms of predicting later good radiographic and functional outcomes, although 28-joint Disease Activity Score-based measures of remission did not predict good radiographic outcomes as well as the other candidate definitions did. Given these and other considerations, we propose that a patient's RA can be defined as being in remission based on one of two definitions: (a) when scores on the tender joint count, swollen joint count, CRP (in mg/dl), and patient global assessment (0-10 scale) are all ≤1, or (b) when the score on the Simplified Disease Activity Index is ≤3.3. Conclusion. We propose two new definitions of remission, both of which can be uniformly applied and widely used in RA clinical trials. We recommend that one of these be selected as an outcome measure in each trial and that the results on both be reported for each trial.

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<name sortKey="Matucci Cerinic, Marco" sort="Matucci Cerinic, Marco" uniqKey="Matucci Cerinic M" first="Marco" last="Matucci-Cerinic">Marco Matucci-Cerinic</name>
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<name sortKey="Furst, Daniel" sort="Furst, Daniel" uniqKey="Furst D" first="Daniel" last="Furst">Daniel Furst</name>
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<name sortKey="Gomez Reino, Juan" sort="Gomez Reino, Juan" uniqKey="Gomez Reino J" first="Juan" last="Gomez-Reino">Juan Gomez-Reino</name>
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<name sortKey="Keystone, Edward" sort="Keystone, Edward" uniqKey="Keystone E" first="Edward" last="Keystone">Edward Keystone</name>
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<name sortKey="Khanna, Dinesh" sort="Khanna, Dinesh" uniqKey="Khanna D" first="Dinesh" last="Khanna">Dinesh Khanna</name>
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<name sortKey="Kirwan, John" sort="Kirwan, John" uniqKey="Kirwan J" first="John" last="Kirwan">John Kirwan</name>
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<name sortKey="Kvien, Tore K" sort="Kvien, Tore K" uniqKey="Kvien T" first="Tore K." last="Kvien">Tore K. Kvien</name>
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<name sortKey="Landewe, Robert" sort="Landewe, Robert" uniqKey="Landewe R" first="Robert" last="Landewe">Robert Landewe</name>
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<name sortKey="Michaud, Kaleb" sort="Michaud, Kaleb" uniqKey="Michaud K" first="Kaleb" last="Michaud">Kaleb Michaud</name>
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<author>
<name sortKey="Martin Mola, Emilio" sort="Martin Mola, Emilio" uniqKey="Martin Mola E" first="Emilio" last="Martin-Mola">Emilio Martin-Mola</name>
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<name sortKey="Montie, Pamela" sort="Montie, Pamela" uniqKey="Montie P" first="Pamela" last="Montie">Pamela Montie</name>
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<name sortKey="Pincus, Theodore" sort="Pincus, Theodore" uniqKey="Pincus T" first="Theodore" last="Pincus">Theodore Pincus</name>
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<name sortKey="Richards, Pamela" sort="Richards, Pamela" uniqKey="Richards P" first="Pamela" last="Richards">Pamela Richards</name>
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<author>
<name sortKey="Siegel, Jeffrey N" sort="Siegel, Jeffrey N" uniqKey="Siegel J" first="Jeffrey N." last="Siegel">Jeffrey N. Siegel</name>
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<author>
<name sortKey="Simon, Lee S" sort="Simon, Lee S" uniqKey="Simon L" first="Lee S." last="Simon">Lee S. Simon</name>
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<author>
<name sortKey="Sokka, Tuulikki" sort="Sokka, Tuulikki" uniqKey="Sokka T" first="Tuulikki" last="Sokka">Tuulikki Sokka</name>
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<name sortKey="Strand, Vibeke" sort="Strand, Vibeke" uniqKey="Strand V" first="Vibeke" last="Strand">Vibeke Strand</name>
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<name sortKey="Tugwell, Peter" sort="Tugwell, Peter" uniqKey="Tugwell P" first="Peter" last="Tugwell">Peter Tugwell</name>
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<s1>University of Ottawa</s1>
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<name sortKey="Tyndall, Alan" sort="Tyndall, Alan" uniqKey="Tyndall A" first="Alan" last="Tyndall">Alan Tyndall</name>
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<name sortKey="Van Der Heijde, Desiree" sort="Van Der Heijde, Desiree" uniqKey="Van Der Heijde D" first="Desirée" last="Van Der Heijde">Desirée Van Der Heijde</name>
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<name sortKey="Verstappen, Suzan" sort="Verstappen, Suzan" uniqKey="Verstappen S" first="Suzan" last="Verstappen">Suzan Verstappen</name>
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<name sortKey="White, Barbara" sort="White, Barbara" uniqKey="White B" first="Barbara" last="White">Barbara White</name>
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<author>
<name sortKey="Wolfe, Frederick" sort="Wolfe, Frederick" uniqKey="Wolfe F" first="Frederick" last="Wolfe">Frederick Wolfe</name>
</author>
<author>
<name sortKey="Zink, Angela" sort="Zink, Angela" uniqKey="Zink A" first="Angela" last="Zink">Angela Zink</name>
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<author>
<name sortKey="Boers, Maarten" sort="Boers, Maarten" uniqKey="Boers M" first="Maarten" last="Boers">Maarten Boers</name>
<affiliation wicri:level="3">
<inist:fA14 i1="06">
<s1>VU University Medical Center</s1>
<s2>Amsterdam</s2>
<s3>NLD</s3>
<sZ>5 aut.</sZ>
<sZ>44 aut.</sZ>
</inist:fA14>
<country>Pays-Bas</country>
<placeName>
<settlement type="city">Amsterdam</settlement>
<region nuts="2" type="province">Hollande-Septentrionale</region>
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<title xml:lang="en" level="a">American College of Rheumatology/European League Against Rheumatism Provisional Definition of Remission in Rheumatoid Arthritis for Clinical Trials</title>
<author>
<name sortKey="Felson, David T" sort="Felson, David T" uniqKey="Felson D" first="David T." last="Felson">David T. Felson</name>
<affiliation wicri:level="1">
<inist:fA14 i1="13">
<s1>University of Florence</s1>
<s2>Florence</s2>
<s3>ITA</s3>
<sZ>1 aut.</sZ>
<sZ>13 aut.</sZ>
</inist:fA14>
<country>Italie</country>
<wicri:noRegion>University of Florence</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Smolen, Josef S" sort="Smolen, Josef S" uniqKey="Smolen J" first="Josef S." last="Smolen">Josef S. Smolen</name>
<affiliation wicri:level="4">
<inist:fA14 i1="02">
<s1>University of Manchester</s1>
<s2>Manchester</s2>
<s3>GBR</s3>
<sZ>2 aut.</sZ>
</inist:fA14>
<country>Royaume-Uni</country>
<placeName>
<settlement type="city">Manchester</settlement>
<region type="country">Angleterre</region>
<region type="région" nuts="1">Grand Manchester</region>
<settlement type="city">Manchester</settlement>
</placeName>
<orgName type="university">Université de Manchester</orgName>
</affiliation>
<affiliation wicri:level="3">
<inist:fA14 i1="03">
<s1>Medical University of Vienna and Hietzing Hospital</s1>
<s2>Vienna</s2>
<s3>AUT</s3>
<sZ>2 aut.</sZ>
</inist:fA14>
<country>Autriche</country>
<placeName>
<settlement type="city">Vienne (Autriche)</settlement>
<region nuts="2" type="province">Vienne (Autriche)</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Wells, George" sort="Wells, George" uniqKey="Wells G" first="George" last="Wells">George Wells</name>
<affiliation wicri:level="1">
<inist:fA14 i1="04">
<s1>University of Ottawa</s1>
<s2>Ottawa, Ontario</s2>
<s3>CAN</s3>
<sZ>3 aut.</sZ>
<sZ>37 aut.</sZ>
</inist:fA14>
<country>Canada</country>
<wicri:noRegion>University of Ottawa</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Bin Zhang" sort="Bin Zhang" uniqKey="Bin Zhang" last="Bin Zhang">BIN ZHANG</name>
<affiliation wicri:level="2">
<inist:fA14 i1="01">
<s1>Boston University School of Medicine</s1>
<s2>Boston, Massachusetts</s2>
<s3>USA</s3>
<sZ>4 aut.</sZ>
<sZ>14 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName>
<region type="state">Massachusetts</region>
</placeName>
</affiliation>
<affiliation wicri:level="2">
<inist:fA14 i1="05">
<s1>Boston University School of Medicine</s1>
<s2>Boston, Massachusetts</s2>
<s3>USA</s3>
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<country>États-Unis</country>
<placeName>
<region type="state">Massachusetts</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Van Tuyl, Lilian H D" sort="Van Tuyl, Lilian H D" uniqKey="Van Tuyl L" first="Lilian H. D." last="Van Tuyl">Lilian H. D. Van Tuyl</name>
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<s1>VU University Medical Center</s1>
<s2>Amsterdam</s2>
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<country>Pays-Bas</country>
<placeName>
<settlement type="city">Amsterdam</settlement>
<region nuts="2" type="province">Hollande-Septentrionale</region>
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</affiliation>
</author>
<author>
<name sortKey="Funovits, Julia" sort="Funovits, Julia" uniqKey="Funovits J" first="Julia" last="Funovits">Julia Funovits</name>
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<s1>Medical University of Vienna</s1>
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</inist:fA14>
<country>Autriche</country>
<placeName>
<settlement type="city">Vienne (Autriche)</settlement>
<region nuts="2" type="province">Vienne (Autriche)</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Aletaha, Daniel" sort="Aletaha, Daniel" uniqKey="Aletaha D" first="Daniel" last="Aletaha">Daniel Aletaha</name>
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<inist:fA14 i1="07">
<s1>Medical University of Vienna</s1>
<s2>Vienna</s2>
<s3>AUT</s3>
<sZ>6 aut.</sZ>
<sZ>7 aut.</sZ>
</inist:fA14>
<country>Autriche</country>
<placeName>
<settlement type="city">Vienne (Autriche)</settlement>
<region nuts="2" type="province">Vienne (Autriche)</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Allaart, Cornelia F" sort="Allaart, Cornelia F" uniqKey="Allaart C" first="Cornelia F." last="Allaart">Cornelia F. Allaart</name>
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<inist:fA14 i1="08">
<s1>Leiden University Medical Center</s1>
<s2>Leiden</s2>
<s3>NLD</s3>
<sZ>8 aut.</sZ>
<sZ>39 aut.</sZ>
</inist:fA14>
<country>Pays-Bas</country>
<placeName>
<settlement type="city">Leyde</settlement>
<region nuts="2" type="province">Hollande-Méridionale</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Bathon, Joan" sort="Bathon, Joan" uniqKey="Bathon J" first="Joan" last="Bathon">Joan Bathon</name>
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<inist:fA14 i1="09">
<s1>Johns Hopkins University School of Medicine</s1>
<s2>Baltimore, Maryland</s2>
<s3>USA</s3>
<sZ>9 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName>
<region type="state">Maryland</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Bombardieri, Stefano" sort="Bombardieri, Stefano" uniqKey="Bombardieri S" first="Stefano" last="Bombardieri">Stefano Bombardieri</name>
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<inist:fA14 i1="10">
<s1>University of Pisa</s1>
<s2>Pisa</s2>
<s3>ITA</s3>
<sZ>10 aut.</sZ>
</inist:fA14>
<country>Italie</country>
<placeName>
<settlement type="city">Pise</settlement>
<region nuts="2">Toscane</region>
<settlement type="city">Pise</settlement>
</placeName>
<orgName type="university">Université de Pise</orgName>
</affiliation>
</author>
<author>
<name sortKey="Brooks, Peter" sort="Brooks, Peter" uniqKey="Brooks P" first="Peter" last="Brooks">Peter Brooks</name>
<affiliation wicri:level="4">
<inist:fA14 i1="11">
<s1>University of Melbourne, Melbourne</s1>
<s2>Victoria</s2>
<s3>AUS</s3>
<sZ>11 aut.</sZ>
</inist:fA14>
<country>Australie</country>
<placeName>
<settlement type="city">Melbourne</settlement>
<region type="état">Victoria (État)</region>
<settlement type="city">Melbourne</settlement>
</placeName>
<orgName type="university">Université de Melbourne</orgName>
</affiliation>
</author>
<author>
<name sortKey="Brown, Andrew" sort="Brown, Andrew" uniqKey="Brown A" first="Andrew" last="Brown">Andrew Brown</name>
<affiliation wicri:level="1">
<inist:fA14 i1="12">
<s1>University of York</s1>
<s2>York</s2>
<s3>GBR</s3>
<sZ>12 aut.</sZ>
</inist:fA14>
<country>Royaume-Uni</country>
<wicri:noRegion>University of York</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Matucci Cerinic, Marco" sort="Matucci Cerinic, Marco" uniqKey="Matucci Cerinic M" first="Marco" last="Matucci-Cerinic">Marco Matucci-Cerinic</name>
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<inist:fA14 i1="13">
<s1>University of Florence</s1>
<s2>Florence</s2>
<s3>ITA</s3>
<sZ>1 aut.</sZ>
<sZ>13 aut.</sZ>
</inist:fA14>
<country>Italie</country>
<wicri:noRegion>University of Florence</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Choi, Hyon" sort="Choi, Hyon" uniqKey="Choi H" first="Hyon" last="Choi">Hyon Choi</name>
<affiliation wicri:level="2">
<inist:fA14 i1="01">
<s1>Boston University School of Medicine</s1>
<s2>Boston, Massachusetts</s2>
<s3>USA</s3>
<sZ>4 aut.</sZ>
<sZ>14 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName>
<region type="state">Massachusetts</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Combe, Bernard" sort="Combe, Bernard" uniqKey="Combe B" first="Bernard" last="Combe">Bernard Combe</name>
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<inist:fA14 i1="14">
<s1>Montpellier University Hospital</s1>
<s2>Montpellier</s2>
<s3>FRA</s3>
<sZ>15 aut.</sZ>
</inist:fA14>
<country>France</country>
<placeName>
<region type="region">Occitanie (région administrative)</region>
<region type="old region">Languedoc-Roussillon</region>
<settlement type="city">Montpellier</settlement>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="De Wit, Maarten" sort="De Wit, Maarten" uniqKey="De Wit M" first="Maarten" last="De Wit">Maarten De Wit</name>
<affiliation wicri:level="1">
<inist:fA14 i1="16">
<s1>University of Leeds and NIHR Leeds Musculoskeletal Biomedical Research Unit</s1>
<s2>Leeds</s2>
<s3>GBR</s3>
<sZ>16 aut.</sZ>
<sZ>18 aut.</sZ>
</inist:fA14>
<country>Royaume-Uni</country>
<wicri:noRegion>University of Leeds and NIHR Leeds Musculoskeletal Biomedical Research Unit</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Dougados, Maxime" sort="Dougados, Maxime" uniqKey="Dougados M" first="Maxime" last="Dougados">Maxime Dougados</name>
<affiliation wicri:level="3">
<inist:fA14 i1="15">
<s1>Paris-Descartes University, UPRES-EA, Assistance Publique Hôpitaux de Paris, and Cochin Hospital</s1>
<s2>Paris</s2>
<s3>FRA</s3>
<sZ>17 aut.</sZ>
</inist:fA14>
<country>France</country>
<placeName>
<region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<settlement type="city">Paris</settlement>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Emery, Paul" sort="Emery, Paul" uniqKey="Emery P" first="Paul" last="Emery">Paul Emery</name>
<affiliation wicri:level="1">
<inist:fA14 i1="16">
<s1>University of Leeds and NIHR Leeds Musculoskeletal Biomedical Research Unit</s1>
<s2>Leeds</s2>
<s3>GBR</s3>
<sZ>16 aut.</sZ>
<sZ>18 aut.</sZ>
</inist:fA14>
<country>Royaume-Uni</country>
<wicri:noRegion>University of Leeds and NIHR Leeds Musculoskeletal Biomedical Research Unit</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Furst, Daniel" sort="Furst, Daniel" uniqKey="Furst D" first="Daniel" last="Furst">Daniel Furst</name>
<affiliation wicri:level="1">
<inist:fA14 i1="17">
<s1>David Geffen School of Medicine at the University of California in Los Angeles</s1>
<s3>USA</s3>
<sZ>19 aut.</sZ>
<sZ>23 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>David Geffen School of Medicine at the University of California in Los Angeles</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Gomez Reino, Juan" sort="Gomez Reino, Juan" uniqKey="Gomez Reino J" first="Juan" last="Gomez-Reino">Juan Gomez-Reino</name>
<affiliation wicri:level="1">
<inist:fA14 i1="18">
<s1>Hospital Clinico Universitario and Universidad de Santiago de Compostela</s1>
<s2>Santiago</s2>
<s3>ESP</s3>
<sZ>20 aut.</sZ>
</inist:fA14>
<country>Espagne</country>
<wicri:noRegion>Hospital Clinico Universitario and Universidad de Santiago de Compostela</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Hawker, Gillian" sort="Hawker, Gillian" uniqKey="Hawker G" first="Gillian" last="Hawker">Gillian Hawker</name>
</author>
<author>
<name sortKey="Keystone, Edward" sort="Keystone, Edward" uniqKey="Keystone E" first="Edward" last="Keystone">Edward Keystone</name>
</author>
<author>
<name sortKey="Khanna, Dinesh" sort="Khanna, Dinesh" uniqKey="Khanna D" first="Dinesh" last="Khanna">Dinesh Khanna</name>
<affiliation wicri:level="1">
<inist:fA14 i1="17">
<s1>David Geffen School of Medicine at the University of California in Los Angeles</s1>
<s3>USA</s3>
<sZ>19 aut.</sZ>
<sZ>23 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>David Geffen School of Medicine at the University of California in Los Angeles</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Kirwan, John" sort="Kirwan, John" uniqKey="Kirwan J" first="John" last="Kirwan">John Kirwan</name>
</author>
<author>
<name sortKey="Kvien, Tore K" sort="Kvien, Tore K" uniqKey="Kvien T" first="Tore K." last="Kvien">Tore K. Kvien</name>
</author>
<author>
<name sortKey="Landewe, Robert" sort="Landewe, Robert" uniqKey="Landewe R" first="Robert" last="Landewe">Robert Landewe</name>
</author>
<author>
<name sortKey="Listing, Joachim" sort="Listing, Joachim" uniqKey="Listing J" first="Joachim" last="Listing">Joachim Listing</name>
</author>
<author>
<name sortKey="Michaud, Kaleb" sort="Michaud, Kaleb" uniqKey="Michaud K" first="Kaleb" last="Michaud">Kaleb Michaud</name>
</author>
<author>
<name sortKey="Martin Mola, Emilio" sort="Martin Mola, Emilio" uniqKey="Martin Mola E" first="Emilio" last="Martin-Mola">Emilio Martin-Mola</name>
</author>
<author>
<name sortKey="Montie, Pamela" sort="Montie, Pamela" uniqKey="Montie P" first="Pamela" last="Montie">Pamela Montie</name>
</author>
<author>
<name sortKey="Pincus, Theodore" sort="Pincus, Theodore" uniqKey="Pincus T" first="Theodore" last="Pincus">Theodore Pincus</name>
</author>
<author>
<name sortKey="Richards, Pamela" sort="Richards, Pamela" uniqKey="Richards P" first="Pamela" last="Richards">Pamela Richards</name>
</author>
<author>
<name sortKey="Siegel, Jeffrey N" sort="Siegel, Jeffrey N" uniqKey="Siegel J" first="Jeffrey N." last="Siegel">Jeffrey N. Siegel</name>
</author>
<author>
<name sortKey="Simon, Lee S" sort="Simon, Lee S" uniqKey="Simon L" first="Lee S." last="Simon">Lee S. Simon</name>
</author>
<author>
<name sortKey="Sokka, Tuulikki" sort="Sokka, Tuulikki" uniqKey="Sokka T" first="Tuulikki" last="Sokka">Tuulikki Sokka</name>
</author>
<author>
<name sortKey="Strand, Vibeke" sort="Strand, Vibeke" uniqKey="Strand V" first="Vibeke" last="Strand">Vibeke Strand</name>
</author>
<author>
<name sortKey="Tugwell, Peter" sort="Tugwell, Peter" uniqKey="Tugwell P" first="Peter" last="Tugwell">Peter Tugwell</name>
<affiliation wicri:level="1">
<inist:fA14 i1="04">
<s1>University of Ottawa</s1>
<s2>Ottawa, Ontario</s2>
<s3>CAN</s3>
<sZ>3 aut.</sZ>
<sZ>37 aut.</sZ>
</inist:fA14>
<country>Canada</country>
<wicri:noRegion>University of Ottawa</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Tyndall, Alan" sort="Tyndall, Alan" uniqKey="Tyndall A" first="Alan" last="Tyndall">Alan Tyndall</name>
</author>
<author>
<name sortKey="Van Der Heijde, Desiree" sort="Van Der Heijde, Desiree" uniqKey="Van Der Heijde D" first="Desirée" last="Van Der Heijde">Desirée Van Der Heijde</name>
<affiliation wicri:level="3">
<inist:fA14 i1="08">
<s1>Leiden University Medical Center</s1>
<s2>Leiden</s2>
<s3>NLD</s3>
<sZ>8 aut.</sZ>
<sZ>39 aut.</sZ>
</inist:fA14>
<country>Pays-Bas</country>
<placeName>
<settlement type="city">Leyde</settlement>
<region nuts="2" type="province">Hollande-Méridionale</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Verstappen, Suzan" sort="Verstappen, Suzan" uniqKey="Verstappen S" first="Suzan" last="Verstappen">Suzan Verstappen</name>
</author>
<author>
<name sortKey="White, Barbara" sort="White, Barbara" uniqKey="White B" first="Barbara" last="White">Barbara White</name>
</author>
<author>
<name sortKey="Wolfe, Frederick" sort="Wolfe, Frederick" uniqKey="Wolfe F" first="Frederick" last="Wolfe">Frederick Wolfe</name>
</author>
<author>
<name sortKey="Zink, Angela" sort="Zink, Angela" uniqKey="Zink A" first="Angela" last="Zink">Angela Zink</name>
</author>
<author>
<name sortKey="Boers, Maarten" sort="Boers, Maarten" uniqKey="Boers M" first="Maarten" last="Boers">Maarten Boers</name>
<affiliation wicri:level="3">
<inist:fA14 i1="06">
<s1>VU University Medical Center</s1>
<s2>Amsterdam</s2>
<s3>NLD</s3>
<sZ>5 aut.</sZ>
<sZ>44 aut.</sZ>
</inist:fA14>
<country>Pays-Bas</country>
<placeName>
<settlement type="city">Amsterdam</settlement>
<region nuts="2" type="province">Hollande-Septentrionale</region>
</placeName>
</affiliation>
</author>
</analytic>
<series>
<title level="j" type="main">Arthritis and rheumatism</title>
<title level="j" type="abbreviated">Arthritis rheum.</title>
<idno type="ISSN">0004-3591</idno>
<imprint>
<date when="2011">2011</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
<seriesStmt>
<title level="j" type="main">Arthritis and rheumatism</title>
<title level="j" type="abbreviated">Arthritis rheum.</title>
<idno type="ISSN">0004-3591</idno>
</seriesStmt>
</fileDesc>
<profileDesc>
<textClass>
<keywords scheme="KwdEn" xml:lang="en">
<term>Chronic</term>
<term>Clinical trial</term>
<term>Definition</term>
<term>Remission</term>
<term>Rheumatoid arthritis</term>
<term>Rheumatology</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr">
<term>Polyarthrite rhumatoïde</term>
<term>Rhumatologie</term>
<term>Définition</term>
<term>Rémission</term>
<term>Essai clinique</term>
<term>Chronique</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front>
<div type="abstract" xml:lang="en">Objective. Remission in rheumatoid arthritis (RA) is an increasingly attainable goal, but there is no widely used definition of remission that is stringent but achievable and could be applied uniformly as an outcome measure in clinical trials. This work was undertaken to develop such a definition. Methods. A committee consisting of members of the American College of Rheumatology, the European League Against Rheumatism, and the Outcome Measures in Rheumatology Initiative met to guide the process and review prespecified analyses from RA clinical trials. The committee requested a stringent definition (little, if any, active disease) and decided to use core set measures including, as a minimum, joint counts and levels of an acute-phase reactant to define remission. Members were surveyed to select the level of each core set measure that would be consistent with remission. Candidate definitions of remission were tested, including those that constituted a number of individual measures of remission (Boolean approach) as well as definitions using disease activity indexes. To select a definition of remission, trial data were analyzed to examine the added contribution of patient-reported outcomes and the ability of candidate measures to predict later good radiographic and functional outcomes. Results. Survey results for the definition of remission suggested indexes at published thresholds and a count of core set measures, with each measure scored as 1 or less (e.g., tender and swollen joint counts, C-reactive protein [CRP] level, and global assessments on a 0-10 scale). Analyses suggested the need to include a patient-reported measure. Examination of 2-year followup data suggested that many candidate definitions performed comparably in terms of predicting later good radiographic and functional outcomes, although 28-joint Disease Activity Score-based measures of remission did not predict good radiographic outcomes as well as the other candidate definitions did. Given these and other considerations, we propose that a patient's RA can be defined as being in remission based on one of two definitions: (a) when scores on the tender joint count, swollen joint count, CRP (in mg/dl), and patient global assessment (0-10 scale) are all ≤1, or (b) when the score on the Simplified Disease Activity Index is ≤3.3. Conclusion. We propose two new definitions of remission, both of which can be uniformly applied and widely used in RA clinical trials. We recommend that one of these be selected as an outcome measure in each trial and that the results on both be reported for each trial.</div>
</front>
</TEI>
<affiliations>
<list>
<country>
<li>Australie</li>
<li>Autriche</li>
<li>Canada</li>
<li>Espagne</li>
<li>France</li>
<li>Italie</li>
<li>Pays-Bas</li>
<li>Royaume-Uni</li>
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<li>Vienne (Autriche)</li>
<li>Île-de-France</li>
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<li>Amsterdam</li>
<li>Leyde</li>
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<li>Pise</li>
<li>Vienne (Autriche)</li>
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<li>Université de Manchester</li>
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<name sortKey="Smolen, Josef S" sort="Smolen, Josef S" uniqKey="Smolen J" first="Josef S." last="Smolen">Josef S. Smolen</name>
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<name sortKey="Aletaha, Daniel" sort="Aletaha, Daniel" uniqKey="Aletaha D" first="Daniel" last="Aletaha">Daniel Aletaha</name>
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<region name="Massachusetts">
<name sortKey="Bin Zhang" sort="Bin Zhang" uniqKey="Bin Zhang" last="Bin Zhang">BIN ZHANG</name>
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<name sortKey="Bathon, Joan" sort="Bathon, Joan" uniqKey="Bathon J" first="Joan" last="Bathon">Joan Bathon</name>
<name sortKey="Bin Zhang" sort="Bin Zhang" uniqKey="Bin Zhang" last="Bin Zhang">BIN ZHANG</name>
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<name sortKey="Van Tuyl, Lilian H D" sort="Van Tuyl, Lilian H D" uniqKey="Van Tuyl L" first="Lilian H. D." last="Van Tuyl">Lilian H. D. Van Tuyl</name>
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<name sortKey="Van Der Heijde, Desiree" sort="Van Der Heijde, Desiree" uniqKey="Van Der Heijde D" first="Desirée" last="Van Der Heijde">Desirée Van Der Heijde</name>
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<country name="Australie">
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<name sortKey="Brooks, Peter" sort="Brooks, Peter" uniqKey="Brooks P" first="Peter" last="Brooks">Peter Brooks</name>
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<country name="France">
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</country>
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