American College of Rheumatology/European League against Rheumatism Preliminary Definition of Remission in Rheumatoid Arthritis for Clinical Trials
Identifieur interne : 006609 ( Main/Merge ); précédent : 006608; suivant : 006610American College of Rheumatology/European League against Rheumatism Preliminary Definition of Remission in Rheumatoid Arthritis for Clinical Trials
Auteurs : David T. Felson [États-Unis, Royaume-Uni] ; Josef S. Smolen [Autriche] ; George Wells [Canada] ; Bin Zhang [États-Unis] ; Lilian H. D. Van Tuyl [Pays-Bas] ; Julia Funovits [Autriche] ; Daniel Aletaha [Autriche] ; Renée 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 [Pays-Bas] ; Maxime Dougados [France] ; Paul Emery [Royaume-Uni] ; Dan Furst [États-Unis] ; Juan Gomez-Reino [Espagne] ; Gillian Hawker [Canada] ; Edward Keystone [Canada] ; Dinesh Khanna [États-Unis] ; John Kirwan [Royaume-Uni] ; Tore Kvien [Norvège] ; Robert Landewé [Pays-Bas] ; Joachim Listing [Allemagne] ; Kaleb Michaud [États-Unis] ; Emilio Martin Mola [Espagne] ; Pam Montie [Canada] ; Ted Pincus [États-Unis] ; Pam Richards [Royaume-Uni] ; Jeff Siegel [États-Unis] ; Lee Simon [États-Unis] ; Tuulikki Sokka [Finlande] ; Vibeke Strand [États-Unis] ; Peter Tugwell [Canada] ; Alan Tyndall [Suisse] ; Desirée Van Der Heijde [Pays-Bas] ; Suzan Verstappen [Royaume-Uni] ; Barbara White [États-Unis] ; Fred Wolfe [États-Unis] ; Angela Zink [Allemagne] ; Maarten Boers [Pays-Bas]Source :
- Arthritis and rheumatism [ 0004-3591 ] ; 2011.
Abstract
With remission in rheumatoid arthritis (RA) an increasingly attainable goal, there is no widely used definition of remission that is stringent but achievable and could be applied uniformly as an outcome in clinical trials.
A committee consisting of members of the American College of Rheumatology, the European League Against Rheumatism and the Outcome Measures in Rheumatology Initiative (OMERACT) met to guide the process and review prespecified analyses from clinical trials of patients with RA. The committee requested a stringent definition (little, if any, active disease) and decided to use core set measures to define remission including at least joint counts and an acute phase reactant. Members were surveyed to select the level of each core set measure consistent with remission. Candidate definitions of remission were tested including those that constituted a number of individual measures in 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 x-ray and functional outcomes.
Survey results for the definition of remission pointed to indexes at published thresholds and to a count of core set measures with each measure scored as 1 or less (e.g. tender and swollen joint counts, CRP and global assessments on 0-10 scale). Analyses suggested the need to include a patient reported measure. Examination of 2 year follow-up data suggested that many candidate definitions performed comparably in terms of predicting later good x-ray and functional outcomes, although DAS28 based measures of remission did not predict good radiographic outcomes as well as did the other candidate definitions. Given these and other considerations, we propose that a patient be defined as in remission based on one of two definitions : 1: When their scores on the following measures are all
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 in each trial as an outcome and that the results on both be reported in each trial.
Url:
DOI: 10.1002/art.30129
PubMed: 21294106
PubMed Central: 3115717
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<author><name sortKey="Felson, David T" sort="Felson, David T" uniqKey="Felson D" first="David T." last="Felson">David T. Felson</name>
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<affiliation wicri:level="4"><nlm:aff id="A34"> Arthritis Research UK Epidemiology Unit, The University of Manchester, UK.</nlm:aff>
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<author><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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<author><name sortKey="Wells, George" sort="Wells, George" uniqKey="Wells G" first="George" last="Wells">George Wells</name>
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<author><name sortKey="Funovits, Julia" sort="Funovits, Julia" uniqKey="Funovits J" first="Julia" last="Funovits">Julia Funovits</name>
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<author><name sortKey="Aletaha, Daniel" sort="Aletaha, Daniel" uniqKey="Aletaha D" first="Daniel" last="Aletaha">Daniel Aletaha</name>
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<author><name sortKey="Allaart, Renee" sort="Allaart, Renee" uniqKey="Allaart R" first="Renée" last="Allaart">Renée Allaart</name>
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<author><name sortKey="Bathon, Joan" sort="Bathon, Joan" uniqKey="Bathon J" first="Joan" last="Bathon">Joan Bathon</name>
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<author><name sortKey="Bombardieri, Stefano" sort="Bombardieri, Stefano" uniqKey="Bombardieri S" first="Stefano" last="Bombardieri">Stefano Bombardieri</name>
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<author><name sortKey="Brooks, Peter" sort="Brooks, Peter" uniqKey="Brooks P" first="Peter" last="Brooks">Peter Brooks</name>
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<author><name sortKey="Brown, Andrew" sort="Brown, Andrew" uniqKey="Brown A" first="Andrew" last="Brown">Andrew Brown</name>
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<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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<author><name sortKey="Choi, Hyon" sort="Choi, Hyon" uniqKey="Choi H" first="Hyon" last="Choi">Hyon Choi</name>
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<author><name sortKey="Combe, Bernard" sort="Combe, Bernard" uniqKey="Combe B" first="Bernard" last="Combe">Bernard Combe</name>
<affiliation wicri:level="1"><nlm:aff id="A12"> Division Hopital Lapeyronie, Montpellier University Hospital Montpellier, France.</nlm:aff>
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<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="3"><nlm:aff id="A13"> Department of Medical Humanities, VU University Medical Center, Amsterdam, Netherlands.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Pays-Bas</country>
<wicri:regionArea> Department of Medical Humanities, VU University Medical Center, Amsterdam</wicri:regionArea>
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</placeName>
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<author><name sortKey="Dougados, Maxime" sort="Dougados, Maxime" uniqKey="Dougados M" first="Maxime" last="Dougados">Maxime Dougados</name>
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<author><name sortKey="Emery, Paul" sort="Emery, Paul" uniqKey="Emery P" first="Paul" last="Emery">Paul Emery</name>
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<wicri:regionArea> University of Leeds and Leeds Teaching Hospitals NHS Trust</wicri:regionArea>
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<author><name sortKey="Furst, Dan" sort="Furst, Dan" uniqKey="Furst D" first="Dan" last="Furst">Dan Furst</name>
<affiliation wicri:level="1"><nlm:aff id="A16"> David Geffen School of Medicine at the University of California in Los Angeles, USA.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">États-Unis</country>
<wicri:regionArea> David Geffen School of Medicine at the University of California in Los Angeles</wicri:regionArea>
</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"><nlm:aff id="A17"> Hospital Clinico Universitario at the Universidad de Santiago de Compostela, Santiago, Spain.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Espagne</country>
<wicri:regionArea> Hospital Clinico Universitario at the Universidad de Santiago de Compostela, Santiago</wicri:regionArea>
<wicri:noRegion>Santiago</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Hawker, Gillian" sort="Hawker, Gillian" uniqKey="Hawker G" first="Gillian" last="Hawker">Gillian Hawker</name>
<affiliation wicri:level="1"><nlm:aff id="A18"> Women's College Hospital, Toronto, Canada.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Canada</country>
<wicri:regionArea> Women's College Hospital, Toronto</wicri:regionArea>
<wicri:noRegion>Toronto</wicri:noRegion>
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</author>
<author><name sortKey="Keystone, Edward" sort="Keystone, Edward" uniqKey="Keystone E" first="Edward" last="Keystone">Edward Keystone</name>
<affiliation wicri:level="1"><nlm:aff id="A19"> University of Toronto, Canada.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Canada</country>
<wicri:regionArea> University of Toronto</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Khanna, Dinesh" sort="Khanna, Dinesh" uniqKey="Khanna D" first="Dinesh" last="Khanna">Dinesh Khanna</name>
<affiliation wicri:level="1"><nlm:aff id="A16"> David Geffen School of Medicine at the University of California in Los Angeles, USA.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">États-Unis</country>
<wicri:regionArea> David Geffen School of Medicine at the University of California in Los Angeles</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Kirwan, John" sort="Kirwan, John" uniqKey="Kirwan J" first="John" last="Kirwan">John Kirwan</name>
<affiliation wicri:level="1"><nlm:aff id="A20"> University of Bristol, Bristol, UK.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Royaume-Uni</country>
<wicri:regionArea> University of Bristol, Bristol</wicri:regionArea>
<wicri:noRegion>Bristol</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Kvien, Tore" sort="Kvien, Tore" uniqKey="Kvien T" first="Tore" last="Kvien">Tore Kvien</name>
<affiliation wicri:level="3"><nlm:aff id="A21"> Diakonhjemmet Hospital, Oslo, Norway.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Norvège</country>
<wicri:regionArea> Diakonhjemmet Hospital, Oslo</wicri:regionArea>
<placeName><settlement type="city">Oslo</settlement>
<region nuts="2">Østlandet</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Landewe, Robert" sort="Landewe, Robert" uniqKey="Landewe R" first="Robert" last="Landewé">Robert Landewé</name>
<affiliation wicri:level="1"><nlm:aff id="A22"> Department of Internal Medicine/Rheumatology, University Hospital Maastricht, Netherlands.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Pays-Bas</country>
<wicri:regionArea> Department of Internal Medicine/Rheumatology, University Hospital Maastricht</wicri:regionArea>
<wicri:noRegion>University Hospital Maastricht</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Listing, Joachim" sort="Listing, Joachim" uniqKey="Listing J" first="Joachim" last="Listing">Joachim Listing</name>
<affiliation wicri:level="3"><nlm:aff id="A23"> Deutsches Rheuma-Forschungszentrum, Berlin, Germany.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Allemagne</country>
<wicri:regionArea> Deutsches Rheuma-Forschungszentrum, Berlin</wicri:regionArea>
<placeName><region type="land" nuts="3">Berlin</region>
<settlement type="city">Berlin</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Michaud, Kaleb" sort="Michaud, Kaleb" uniqKey="Michaud K" first="Kaleb" last="Michaud">Kaleb Michaud</name>
<affiliation wicri:level="1"><nlm:aff id="A24"> University of Nebraska, Omaha, USA.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">États-Unis</country>
<wicri:regionArea> University of Nebraska, Omaha</wicri:regionArea>
<wicri:noRegion>Omaha</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Mola, Emilio Martin" sort="Mola, Emilio Martin" uniqKey="Mola E" first="Emilio Martin" last="Mola">Emilio Martin Mola</name>
<affiliation wicri:level="3"><nlm:aff id="A25"> Hospital Universitario La Paz, Madrid, Spain.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Espagne</country>
<wicri:regionArea> Hospital Universitario La Paz, Madrid</wicri:regionArea>
<placeName><settlement type="city">Madrid</settlement>
<region nuts="2" type="region">Communauté de Madrid</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Montie, Pam" sort="Montie, Pam" uniqKey="Montie P" first="Pam" last="Montie">Pam Montie</name>
<affiliation wicri:level="1"><nlm:aff id="A26"> Arthritis Research Centre of Canada, Vancouver, Canada.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Canada</country>
<wicri:regionArea> Arthritis Research Centre of Canada, Vancouver</wicri:regionArea>
<wicri:noRegion>Vancouver</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Pincus, Ted" sort="Pincus, Ted" uniqKey="Pincus T" first="Ted" last="Pincus">Ted Pincus</name>
<affiliation wicri:level="2"><nlm:aff id="A27"> New York University School of Medicine, New York, USA.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">États-Unis</country>
<wicri:regionArea> New York University School of Medicine, New York</wicri:regionArea>
<placeName><region type="state">État de New York</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Richards, Pam" sort="Richards, Pam" uniqKey="Richards P" first="Pam" last="Richards">Pam Richards</name>
<affiliation wicri:level="1"><nlm:aff id="A20"> University of Bristol, Bristol, UK.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Royaume-Uni</country>
<wicri:regionArea> University of Bristol, Bristol</wicri:regionArea>
<wicri:noRegion>Bristol</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Siegel, Jeff" sort="Siegel, Jeff" uniqKey="Siegel J" first="Jeff" last="Siegel">Jeff Siegel</name>
<affiliation wicri:level="3"><nlm:aff id="A28"> Food and Drug Administration, Center for Drug Evaluation and Research, Washington DC, USA.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">États-Unis</country>
<wicri:regionArea> Food and Drug Administration, Center for Drug Evaluation and Research, Washington DC</wicri:regionArea>
<placeName><settlement type="city">Washington (district de Columbia)</settlement>
<region type="state">District de Columbia</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Simon, Lee" sort="Simon, Lee" uniqKey="Simon L" first="Lee" last="Simon">Lee Simon</name>
<affiliation wicri:level="1"><nlm:aff id="A29"> SDG LLC, Cambridge, USA.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">États-Unis</country>
<wicri:regionArea> SDG LLC, Cambridge</wicri:regionArea>
<wicri:noRegion>Cambridge</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Sokka, Tuulikki" sort="Sokka, Tuulikki" uniqKey="Sokka T" first="Tuulikki" last="Sokka">Tuulikki Sokka</name>
<affiliation wicri:level="1"><nlm:aff id="A30"> Jyväskylä Central Hospital, Jyväskylä, Finland.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Finlande</country>
<wicri:regionArea> Jyväskylä Central Hospital, Jyväskylä</wicri:regionArea>
<wicri:noRegion>Jyväskylä</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Strand, Vibeke" sort="Strand, Vibeke" uniqKey="Strand V" first="Vibeke" last="Strand">Vibeke Strand</name>
<affiliation wicri:level="1"><nlm:aff id="A31"> Stanford University School of Medicine, Palo Alto, USA.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">États-Unis</country>
<wicri:regionArea> Stanford University School of Medicine, Palo Alto</wicri:regionArea>
<wicri:noRegion>Palo Alto</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Tugwell, Peter" sort="Tugwell, Peter" uniqKey="Tugwell P" first="Peter" last="Tugwell">Peter Tugwell</name>
<affiliation wicri:level="1"><nlm:aff id="A32"> University of Ottawa, Canada.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Canada</country>
<wicri:regionArea> University of Ottawa</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Tyndall, Alan" sort="Tyndall, Alan" uniqKey="Tyndall A" first="Alan" last="Tyndall">Alan Tyndall</name>
<affiliation wicri:level="1"><nlm:aff id="A33"> University of Basel, Switzerland</nlm:aff>
<country xml:lang="fr">Suisse</country>
<wicri:regionArea> University of Basel</wicri:regionArea>
</affiliation>
</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="1"><nlm:aff id="A6"> Leiden University Medical Center, Netherlands.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Pays-Bas</country>
<wicri:regionArea> Leiden University Medical Center</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Verstappen, Suzan" sort="Verstappen, Suzan" uniqKey="Verstappen S" first="Suzan" last="Verstappen">Suzan Verstappen</name>
<affiliation wicri:level="4"><nlm:aff id="A34"> Arthritis Research UK Epidemiology Unit, The University of Manchester, UK.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Royaume-Uni</country>
<wicri:regionArea> Arthritis Research UK Epidemiology Unit, The University of Manchester</wicri:regionArea>
<placeName><settlement type="city">Manchester</settlement>
<region type="nation">Angleterre</region>
<region nuts="2" type="region">Grand Manchester</region>
</placeName>
<orgName type="university">Université de Manchester</orgName>
</affiliation>
</author>
<author><name sortKey="White, Barbara" sort="White, Barbara" uniqKey="White B" first="Barbara" last="White">Barbara White</name>
<affiliation wicri:level="1"><nlm:aff id="A35"> MedImmune, Gaithersburg, USA.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">États-Unis</country>
<wicri:regionArea> MedImmune, Gaithersburg</wicri:regionArea>
<wicri:noRegion>Gaithersburg</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Wolfe, Fred" sort="Wolfe, Fred" uniqKey="Wolfe F" first="Fred" last="Wolfe">Fred Wolfe</name>
<affiliation wicri:level="1"><nlm:aff id="A36"> National Data Bank for Rheumatic Diseases, Wichita, USA.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">États-Unis</country>
<wicri:regionArea> National Data Bank for Rheumatic Diseases, Wichita</wicri:regionArea>
<wicri:noRegion>Wichita</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Zink, Angela" sort="Zink, Angela" uniqKey="Zink A" first="Angela" last="Zink">Angela Zink</name>
<affiliation wicri:level="3"><nlm:aff id="A37"> German Rheumatism Research Center, Berlin, Germany.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Allemagne</country>
<wicri:regionArea> German Rheumatism Research Center, Berlin</wicri:regionArea>
<placeName><region type="land" nuts="3">Berlin</region>
<settlement type="city">Berlin</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Boers, Maarten" sort="Boers, Maarten" uniqKey="Boers M" first="Maarten" last="Boers">Maarten Boers</name>
<affiliation wicri:level="3"><nlm:aff id="A4"> The Department of Epidemiology and Biostatistics and the Department of Rheumatology, VU University Medical Center, Amsterdam, Netherlands</nlm:aff>
<country xml:lang="fr">Pays-Bas</country>
<wicri:regionArea> The Department of Epidemiology and Biostatistics and the Department of Rheumatology, VU University Medical Center, Amsterdam</wicri:regionArea>
<placeName><settlement type="city">Amsterdam</settlement>
<region nuts="2" type="province">Hollande-Septentrionale</region>
</placeName>
</affiliation>
</author>
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<idno type="pmid">21294106</idno>
<idno type="pmc">3115717</idno>
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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">American College of Rheumatology/European League against Rheumatism Preliminary 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"><nlm:aff id="A1"> Clinical Epidemiology Research and Training Unit, Boston University School of Medicine, USA.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">États-Unis</country>
<wicri:regionArea> Clinical Epidemiology Research and Training Unit, Boston University School of Medicine</wicri:regionArea>
<wicri:noRegion>Boston University School of Medicine</wicri:noRegion>
</affiliation>
<affiliation wicri:level="4"><nlm:aff id="A34"> Arthritis Research UK Epidemiology Unit, The University of Manchester, UK.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Royaume-Uni</country>
<wicri:regionArea> Arthritis Research UK Epidemiology Unit, The University of Manchester</wicri:regionArea>
<placeName><settlement type="city">Manchester</settlement>
<region type="nation">Angleterre</region>
<region nuts="2" type="region">Grand Manchester</region>
</placeName>
<orgName type="university">Université de Manchester</orgName>
</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="3"><nlm:aff id="A2"> Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, and 2<sup>nd</sup>
Department of Medicine, Center of Rheumatic Diseases, Hietzing Hospital, Vienna, Austria.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Autriche</country>
<wicri:regionArea> Department of Medicine, Center of Rheumatic Diseases, Hietzing Hospital, Vienna</wicri:regionArea>
<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"><nlm:aff id="A3"> Department of Epidemiology and Community Medicine, University of Ottawa, Canada.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Canada</country>
<wicri:regionArea> Department of Epidemiology and Community Medicine, University of Ottawa</wicri:regionArea>
<wicri:noRegion>University of Ottawa</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Zhang, Bin" sort="Zhang, Bin" uniqKey="Zhang B" first="Bin" last="Zhang">Bin Zhang</name>
<affiliation wicri:level="1"><nlm:aff id="A1"> Clinical Epidemiology Research and Training Unit, Boston University School of Medicine, USA.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">États-Unis</country>
<wicri:regionArea> Clinical Epidemiology Research and Training Unit, Boston University School of Medicine</wicri:regionArea>
<wicri:noRegion>Boston University School of Medicine</wicri:noRegion>
</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>
<affiliation wicri:level="3"><nlm:aff id="A4"> The Department of Epidemiology and Biostatistics and the Department of Rheumatology, VU University Medical Center, Amsterdam, Netherlands</nlm:aff>
<country xml:lang="fr">Pays-Bas</country>
<wicri:regionArea> The Department of Epidemiology and Biostatistics and the Department of Rheumatology, VU University Medical Center, Amsterdam</wicri:regionArea>
<placeName><settlement type="city">Amsterdam</settlement>
<region nuts="2" type="province">Hollande-Septentrionale</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Funovits, Julia" sort="Funovits, Julia" uniqKey="Funovits J" first="Julia" last="Funovits">Julia Funovits</name>
<affiliation wicri:level="3"><nlm:aff id="A5"> Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, Vienna, Austria.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Autriche</country>
<wicri:regionArea> Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, Vienna</wicri:regionArea>
<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>
<affiliation wicri:level="3"><nlm:aff id="A5"> Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, Vienna, Austria.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Autriche</country>
<wicri:regionArea> Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, Vienna</wicri:regionArea>
<placeName><settlement type="city">Vienne (Autriche)</settlement>
<region nuts="2" type="province">Vienne (Autriche)</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Allaart, Renee" sort="Allaart, Renee" uniqKey="Allaart R" first="Renée" last="Allaart">Renée Allaart</name>
<affiliation wicri:level="1"><nlm:aff id="A6"> Leiden University Medical Center, Netherlands.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Pays-Bas</country>
<wicri:regionArea> Leiden University Medical Center</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Bathon, Joan" sort="Bathon, Joan" uniqKey="Bathon J" first="Joan" last="Bathon">Joan Bathon</name>
<affiliation wicri:level="3"><nlm:aff id="A7"> Johns Hopkins University School of Medicine, Baltimore, USA.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">États-Unis</country>
<wicri:regionArea> Johns Hopkins University School of Medicine, Baltimore</wicri:regionArea>
<placeName><settlement type="city">Baltimore</settlement>
<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>
<affiliation wicri:level="1"><nlm:aff id="A8"> University of Pisa, Italy.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Italie</country>
<wicri:regionArea> University of Pisa</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Brooks, Peter" sort="Brooks, Peter" uniqKey="Brooks P" first="Peter" last="Brooks">Peter Brooks</name>
<affiliation wicri:level="4"><nlm:aff id="A9"> University of Melbourne, Melbourne, Australia.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Australie</country>
<wicri:regionArea> University of Melbourne, Melbourne</wicri:regionArea>
<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"><nlm:aff id="A10"> Hull York Medical School, University of York, UK.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Royaume-Uni</country>
<wicri:regionArea> Hull York Medical School, University of York</wicri:regionArea>
<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>
<affiliation wicri:level="1"><nlm:aff id="A11"> University of Florence, Italy.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Italie</country>
<wicri:regionArea> University of Florence</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Choi, Hyon" sort="Choi, Hyon" uniqKey="Choi H" first="Hyon" last="Choi">Hyon Choi</name>
<affiliation wicri:level="1"><nlm:aff id="A1"> Clinical Epidemiology Research and Training Unit, Boston University School of Medicine, USA.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">États-Unis</country>
<wicri:regionArea> Clinical Epidemiology Research and Training Unit, Boston University School of Medicine</wicri:regionArea>
<wicri:noRegion>Boston University School of Medicine</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Combe, Bernard" sort="Combe, Bernard" uniqKey="Combe B" first="Bernard" last="Combe">Bernard Combe</name>
<affiliation wicri:level="1"><nlm:aff id="A12"> Division Hopital Lapeyronie, Montpellier University Hospital Montpellier, France.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">France</country>
<wicri:regionArea> Division Hopital Lapeyronie, Montpellier University Hospital Montpellier</wicri:regionArea>
<wicri:noRegion>Montpellier University Hospital Montpellier</wicri:noRegion>
<wicri:noRegion>Montpellier University Hospital Montpellier</wicri:noRegion>
</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="3"><nlm:aff id="A13"> Department of Medical Humanities, VU University Medical Center, Amsterdam, Netherlands.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Pays-Bas</country>
<wicri:regionArea> Department of Medical Humanities, VU University Medical Center, Amsterdam</wicri:regionArea>
<placeName><settlement type="city">Amsterdam</settlement>
<region nuts="2" type="province">Hollande-Septentrionale</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Dougados, Maxime" sort="Dougados, Maxime" uniqKey="Dougados M" first="Maxime" last="Dougados">Maxime Dougados</name>
<affiliation wicri:level="3"><nlm:aff id="A14"> Paris-Descartes University, Medicine Faculty; UPRES-EA ; AP-HP, Cochin Hospital, Rheumatology B Department, Paris, France.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">France</country>
<wicri:regionArea> Paris-Descartes University, Medicine Faculty; UPRES-EA ; AP-HP, Cochin Hospital, Rheumatology B Department, Paris</wicri:regionArea>
<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"><nlm:aff id="A15"> University of Leeds and Leeds Teaching Hospitals NHS Trust, UK.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Royaume-Uni</country>
<wicri:regionArea> University of Leeds and Leeds Teaching Hospitals NHS Trust</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Furst, Dan" sort="Furst, Dan" uniqKey="Furst D" first="Dan" last="Furst">Dan Furst</name>
<affiliation wicri:level="1"><nlm:aff id="A16"> David Geffen School of Medicine at the University of California in Los Angeles, USA.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">États-Unis</country>
<wicri:regionArea> David Geffen School of Medicine at the University of California in Los Angeles</wicri:regionArea>
</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"><nlm:aff id="A17"> Hospital Clinico Universitario at the Universidad de Santiago de Compostela, Santiago, Spain.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Espagne</country>
<wicri:regionArea> Hospital Clinico Universitario at the Universidad de Santiago de Compostela, Santiago</wicri:regionArea>
<wicri:noRegion>Santiago</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Hawker, Gillian" sort="Hawker, Gillian" uniqKey="Hawker G" first="Gillian" last="Hawker">Gillian Hawker</name>
<affiliation wicri:level="1"><nlm:aff id="A18"> Women's College Hospital, Toronto, Canada.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Canada</country>
<wicri:regionArea> Women's College Hospital, Toronto</wicri:regionArea>
<wicri:noRegion>Toronto</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Keystone, Edward" sort="Keystone, Edward" uniqKey="Keystone E" first="Edward" last="Keystone">Edward Keystone</name>
<affiliation wicri:level="1"><nlm:aff id="A19"> University of Toronto, Canada.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Canada</country>
<wicri:regionArea> University of Toronto</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Khanna, Dinesh" sort="Khanna, Dinesh" uniqKey="Khanna D" first="Dinesh" last="Khanna">Dinesh Khanna</name>
<affiliation wicri:level="1"><nlm:aff id="A16"> David Geffen School of Medicine at the University of California in Los Angeles, USA.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">États-Unis</country>
<wicri:regionArea> David Geffen School of Medicine at the University of California in Los Angeles</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Kirwan, John" sort="Kirwan, John" uniqKey="Kirwan J" first="John" last="Kirwan">John Kirwan</name>
<affiliation wicri:level="1"><nlm:aff id="A20"> University of Bristol, Bristol, UK.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Royaume-Uni</country>
<wicri:regionArea> University of Bristol, Bristol</wicri:regionArea>
<wicri:noRegion>Bristol</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Kvien, Tore" sort="Kvien, Tore" uniqKey="Kvien T" first="Tore" last="Kvien">Tore Kvien</name>
<affiliation wicri:level="3"><nlm:aff id="A21"> Diakonhjemmet Hospital, Oslo, Norway.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Norvège</country>
<wicri:regionArea> Diakonhjemmet Hospital, Oslo</wicri:regionArea>
<placeName><settlement type="city">Oslo</settlement>
<region nuts="2">Østlandet</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Landewe, Robert" sort="Landewe, Robert" uniqKey="Landewe R" first="Robert" last="Landewé">Robert Landewé</name>
<affiliation wicri:level="1"><nlm:aff id="A22"> Department of Internal Medicine/Rheumatology, University Hospital Maastricht, Netherlands.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Pays-Bas</country>
<wicri:regionArea> Department of Internal Medicine/Rheumatology, University Hospital Maastricht</wicri:regionArea>
<wicri:noRegion>University Hospital Maastricht</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Listing, Joachim" sort="Listing, Joachim" uniqKey="Listing J" first="Joachim" last="Listing">Joachim Listing</name>
<affiliation wicri:level="3"><nlm:aff id="A23"> Deutsches Rheuma-Forschungszentrum, Berlin, Germany.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Allemagne</country>
<wicri:regionArea> Deutsches Rheuma-Forschungszentrum, Berlin</wicri:regionArea>
<placeName><region type="land" nuts="3">Berlin</region>
<settlement type="city">Berlin</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Michaud, Kaleb" sort="Michaud, Kaleb" uniqKey="Michaud K" first="Kaleb" last="Michaud">Kaleb Michaud</name>
<affiliation wicri:level="1"><nlm:aff id="A24"> University of Nebraska, Omaha, USA.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">États-Unis</country>
<wicri:regionArea> University of Nebraska, Omaha</wicri:regionArea>
<wicri:noRegion>Omaha</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Mola, Emilio Martin" sort="Mola, Emilio Martin" uniqKey="Mola E" first="Emilio Martin" last="Mola">Emilio Martin Mola</name>
<affiliation wicri:level="3"><nlm:aff id="A25"> Hospital Universitario La Paz, Madrid, Spain.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Espagne</country>
<wicri:regionArea> Hospital Universitario La Paz, Madrid</wicri:regionArea>
<placeName><settlement type="city">Madrid</settlement>
<region nuts="2" type="region">Communauté de Madrid</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Montie, Pam" sort="Montie, Pam" uniqKey="Montie P" first="Pam" last="Montie">Pam Montie</name>
<affiliation wicri:level="1"><nlm:aff id="A26"> Arthritis Research Centre of Canada, Vancouver, Canada.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Canada</country>
<wicri:regionArea> Arthritis Research Centre of Canada, Vancouver</wicri:regionArea>
<wicri:noRegion>Vancouver</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Pincus, Ted" sort="Pincus, Ted" uniqKey="Pincus T" first="Ted" last="Pincus">Ted Pincus</name>
<affiliation wicri:level="2"><nlm:aff id="A27"> New York University School of Medicine, New York, USA.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">États-Unis</country>
<wicri:regionArea> New York University School of Medicine, New York</wicri:regionArea>
<placeName><region type="state">État de New York</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Richards, Pam" sort="Richards, Pam" uniqKey="Richards P" first="Pam" last="Richards">Pam Richards</name>
<affiliation wicri:level="1"><nlm:aff id="A20"> University of Bristol, Bristol, UK.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Royaume-Uni</country>
<wicri:regionArea> University of Bristol, Bristol</wicri:regionArea>
<wicri:noRegion>Bristol</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Siegel, Jeff" sort="Siegel, Jeff" uniqKey="Siegel J" first="Jeff" last="Siegel">Jeff Siegel</name>
<affiliation wicri:level="3"><nlm:aff id="A28"> Food and Drug Administration, Center for Drug Evaluation and Research, Washington DC, USA.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">États-Unis</country>
<wicri:regionArea> Food and Drug Administration, Center for Drug Evaluation and Research, Washington DC</wicri:regionArea>
<placeName><settlement type="city">Washington (district de Columbia)</settlement>
<region type="state">District de Columbia</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Simon, Lee" sort="Simon, Lee" uniqKey="Simon L" first="Lee" last="Simon">Lee Simon</name>
<affiliation wicri:level="1"><nlm:aff id="A29"> SDG LLC, Cambridge, USA.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">États-Unis</country>
<wicri:regionArea> SDG LLC, Cambridge</wicri:regionArea>
<wicri:noRegion>Cambridge</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Sokka, Tuulikki" sort="Sokka, Tuulikki" uniqKey="Sokka T" first="Tuulikki" last="Sokka">Tuulikki Sokka</name>
<affiliation wicri:level="1"><nlm:aff id="A30"> Jyväskylä Central Hospital, Jyväskylä, Finland.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Finlande</country>
<wicri:regionArea> Jyväskylä Central Hospital, Jyväskylä</wicri:regionArea>
<wicri:noRegion>Jyväskylä</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Strand, Vibeke" sort="Strand, Vibeke" uniqKey="Strand V" first="Vibeke" last="Strand">Vibeke Strand</name>
<affiliation wicri:level="1"><nlm:aff id="A31"> Stanford University School of Medicine, Palo Alto, USA.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">États-Unis</country>
<wicri:regionArea> Stanford University School of Medicine, Palo Alto</wicri:regionArea>
<wicri:noRegion>Palo Alto</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Tugwell, Peter" sort="Tugwell, Peter" uniqKey="Tugwell P" first="Peter" last="Tugwell">Peter Tugwell</name>
<affiliation wicri:level="1"><nlm:aff id="A32"> University of Ottawa, Canada.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Canada</country>
<wicri:regionArea> University of Ottawa</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Tyndall, Alan" sort="Tyndall, Alan" uniqKey="Tyndall A" first="Alan" last="Tyndall">Alan Tyndall</name>
<affiliation wicri:level="1"><nlm:aff id="A33"> University of Basel, Switzerland</nlm:aff>
<country xml:lang="fr">Suisse</country>
<wicri:regionArea> University of Basel</wicri:regionArea>
</affiliation>
</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="1"><nlm:aff id="A6"> Leiden University Medical Center, Netherlands.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Pays-Bas</country>
<wicri:regionArea> Leiden University Medical Center</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Verstappen, Suzan" sort="Verstappen, Suzan" uniqKey="Verstappen S" first="Suzan" last="Verstappen">Suzan Verstappen</name>
<affiliation wicri:level="4"><nlm:aff id="A34"> Arthritis Research UK Epidemiology Unit, The University of Manchester, UK.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Royaume-Uni</country>
<wicri:regionArea> Arthritis Research UK Epidemiology Unit, The University of Manchester</wicri:regionArea>
<placeName><settlement type="city">Manchester</settlement>
<region type="nation">Angleterre</region>
<region nuts="2" type="region">Grand Manchester</region>
</placeName>
<orgName type="university">Université de Manchester</orgName>
</affiliation>
</author>
<author><name sortKey="White, Barbara" sort="White, Barbara" uniqKey="White B" first="Barbara" last="White">Barbara White</name>
<affiliation wicri:level="1"><nlm:aff id="A35"> MedImmune, Gaithersburg, USA.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">États-Unis</country>
<wicri:regionArea> MedImmune, Gaithersburg</wicri:regionArea>
<wicri:noRegion>Gaithersburg</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Wolfe, Fred" sort="Wolfe, Fred" uniqKey="Wolfe F" first="Fred" last="Wolfe">Fred Wolfe</name>
<affiliation wicri:level="1"><nlm:aff id="A36"> National Data Bank for Rheumatic Diseases, Wichita, USA.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">États-Unis</country>
<wicri:regionArea> National Data Bank for Rheumatic Diseases, Wichita</wicri:regionArea>
<wicri:noRegion>Wichita</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Zink, Angela" sort="Zink, Angela" uniqKey="Zink A" first="Angela" last="Zink">Angela Zink</name>
<affiliation wicri:level="3"><nlm:aff id="A37"> German Rheumatism Research Center, Berlin, Germany.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Allemagne</country>
<wicri:regionArea> German Rheumatism Research Center, Berlin</wicri:regionArea>
<placeName><region type="land" nuts="3">Berlin</region>
<settlement type="city">Berlin</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Boers, Maarten" sort="Boers, Maarten" uniqKey="Boers M" first="Maarten" last="Boers">Maarten Boers</name>
<affiliation wicri:level="3"><nlm:aff id="A4"> The Department of Epidemiology and Biostatistics and the Department of Rheumatology, VU University Medical Center, Amsterdam, Netherlands</nlm:aff>
<country xml:lang="fr">Pays-Bas</country>
<wicri:regionArea> The Department of Epidemiology and Biostatistics and the Department of Rheumatology, VU University Medical Center, Amsterdam</wicri:regionArea>
<placeName><settlement type="city">Amsterdam</settlement>
<region nuts="2" type="province">Hollande-Septentrionale</region>
</placeName>
</affiliation>
</author>
</analytic>
<series><title level="j">Arthritis and rheumatism</title>
<idno type="ISSN">0004-3591</idno>
<idno type="eISSN">1529-0131</idno>
<imprint><date when="2011">2011</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
</fileDesc>
<profileDesc><textClass></textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en"><sec id="S1"><title>Background</title>
<p id="P2">With remission in rheumatoid arthritis (RA) an increasingly attainable goal, there is no widely used definition of remission that is stringent but achievable and could be applied uniformly as an outcome in clinical trials.</p>
</sec>
<sec sec-type="methods" id="S2"><title>Methods</title>
<p id="P3">A committee consisting of members of the American College of Rheumatology, the European League Against Rheumatism and the Outcome Measures in Rheumatology Initiative (OMERACT) met to guide the process and review prespecified analyses from clinical trials of patients with RA. The committee requested a stringent definition (little, if any, active disease) and decided to use core set measures to define remission including at least joint counts and an acute phase reactant. Members were surveyed to select the level of each core set measure consistent with remission. Candidate definitions of remission were tested including those that constituted a number of individual measures in 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 x-ray and functional outcomes.</p>
</sec>
<sec id="S3"><title>Results</title>
<p id="P4">Survey results for the definition of remission pointed to indexes at published thresholds and to a count of core set measures with each measure scored as 1 or less (e.g. tender and swollen joint counts, CRP and global assessments on 0-10 scale). Analyses suggested the need to include a patient reported measure. Examination of 2 year follow-up data suggested that many candidate definitions performed comparably in terms of predicting later good x-ray and functional outcomes, although DAS28 based measures of remission did not predict good radiographic outcomes as well as did the other candidate definitions. Given these and other considerations, we propose that a patient be defined as in remission based on one of two definitions : 1: When their scores on the following measures are all <underline><</underline>
1: tender joint count, swollen joint count, CRP (in mg/dL) and patient global assessment (0-10 scale), OR 2: when their score on the SDAI is <underline><</underline>
3.3.</p>
</sec>
<sec id="S4"><title>Conclusion</title>
<p id="P5">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 in each trial as an outcome and that the results on both be reported in each trial.</p>
</sec>
</div>
</front>
</TEI>
</record>
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