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

Identifieur interne : 006274 ( Main/Exploration ); précédent : 006273; suivant : 006275

American College of Rheumatology/European League Against Rheumatism Provisional 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 [Pays-Bas] ; Lilian H D. Van Tuyl [États-Unis] ; 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 [Canada] ; Bernard Combe [France] ; Maarten De Wit [Pays-Bas] ; Maxime Dougados [France] ; Paul Emery [Royaume-Uni] ; Daniel Furst [États-Unis] ; Juan Gomez-Reino [Espagne] ; Gillian Hawker [Canada] ; Edward Keystone [Canada] ; Dinesh Khanna [États-Unis] ; John Kirwan [Royaume-Uni] ; Tore K. Kvien [Norvège] ; Robert Landewé [Pays-Bas] ; Joachim Listing ; Kaleb Michaud ; Emilio Martin-Mola [Espagne] ; Pamela Montie [Canada] ; Theodore Pincus [États-Unis] ; Pamela Richards [Royaume-Uni] ; Jeffrey N. Siegel [États-Unis] ; Lee S. Simon [États-Unis] ; Tuulikki Sokka [Finlande] ; Vibeke Strand [États-Unis] ; Peter Tugwell [Autriche] ; Alan Tyndall [Suisse] ; Desirée Van Der Heijde [Pays-Bas] ; Suzan Verstappen [Royaume-Uni] ; Barbara White [États-Unis] ; Frederick Wolfe [États-Unis] ; Angela Zink ; Maarten Boers [Pays-Bas]

Source :

RBID : ISTEX:58C969D470E41931B1D8C51B9CA5A0599507F4DE

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 analysed 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 (eg, 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 follow-up 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: (1) 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 (2) 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. The authors 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.

Url:
DOI: 10.1136/ard.2011.149765


Affiliations:


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<wicri:regionArea>David Geffen School of Medicine, University of California, Los Angeles, California</wicri:regionArea>
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<author>
<name sortKey="Kirwan, John" sort="Kirwan, John" uniqKey="Kirwan J" first="John" last="Kirwan">John Kirwan</name>
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<settlement type="city">Oslo</settlement>
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<wicri:noCountry code="subField">Omaha</wicri:noCountry>
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<author>
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<wicri:regionArea>Hospital Universitario La Paz, Madrid</wicri:regionArea>
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<settlement type="city">Madrid</settlement>
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<country xml:lang="fr">Canada</country>
<wicri:regionArea>Vancouver, British Columbia</wicri:regionArea>
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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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<country xml:lang="fr">États-Unis</country>
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<region type="state">État de New York</region>
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<wicri:cityArea>New York University School of Medicine, New York</wicri:cityArea>
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<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Bristol</wicri:regionArea>
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<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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<region type="state">District de Columbia</region>
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<name sortKey="Simon, Lee S" sort="Simon, Lee S" uniqKey="Simon L" first="Lee S" last="Simon">Lee S. Simon</name>
<affiliation wicri:level="2">
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>SDG LLC, Cambridge, Massachusetts</wicri:regionArea>
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<region type="state">Massachusetts</region>
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</affiliation>
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<author>
<name sortKey="Sokka, Tuulikki" sort="Sokka, Tuulikki" uniqKey="Sokka T" first="Tuulikki" last="Sokka">Tuulikki Sokka</name>
<affiliation wicri:level="1">
<country xml:lang="fr">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="2">
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Stanford University School of Medicine, Palo Alto, California</wicri:regionArea>
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<region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Tugwell, Peter" sort="Tugwell, Peter" uniqKey="Tugwell P" first="Peter" last="Tugwell">Peter Tugwell</name>
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<country xml:lang="fr">Autriche</country>
<wicri:regionArea>Medical University of Vienna and Hietzing Hospital, Vienna</wicri:regionArea>
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<settlement type="city">Vienne (Autriche)</settlement>
<region nuts="2" type="province">Vienne (Autriche)</region>
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<author>
<name sortKey="Tyndall, Alan" sort="Tyndall, Alan" uniqKey="Tyndall A" first="Alan" last="Tyndall">Alan Tyndall</name>
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<country xml:lang="fr">Suisse</country>
<wicri:regionArea>University of Basel, Basel</wicri:regionArea>
<wicri:noRegion>Basel</wicri:noRegion>
</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="3">
<country xml:lang="fr">Pays-Bas</country>
<wicri:regionArea>Leiden University Medical Center, Leiden</wicri:regionArea>
<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>
<affiliation wicri:level="4">
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>University of Manchester, Manchester</wicri:regionArea>
<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>
</author>
<author>
<name sortKey="White, Barbara" sort="White, Barbara" uniqKey="White B" first="Barbara" last="White">Barbara White</name>
<affiliation wicri:level="2">
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<wicri:regionArea>Medlmmune, Gaithersburg, Maryland</wicri:regionArea>
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<region type="state">Maryland</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Wolfe, Frederick" sort="Wolfe, Frederick" uniqKey="Wolfe F" first="Frederick" last="Wolfe">Frederick Wolfe</name>
<affiliation wicri:level="2">
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>National Data Bank for Rheumatic Diseases, Wichita, Kansas</wicri:regionArea>
<placeName>
<region type="state">Kansas</region>
</placeName>
</affiliation>
<affiliation wicri:level="4">
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>University of Kansas, Wichita, Kansas</wicri:regionArea>
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<region type="state">Kansas</region>
<settlement type="city">Lawrence (Kansas)</settlement>
</placeName>
<orgName type="university">Université du Kansas</orgName>
</affiliation>
</author>
<author>
<name sortKey="Zink, Angela" sort="Zink, Angela" uniqKey="Zink A" first="Angela" last="Zink">Angela Zink</name>
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<wicri:noCountry code="subField">many</wicri:noCountry>
</affiliation>
</author>
<author>
<name sortKey="Boers, Maarten" sort="Boers, Maarten" uniqKey="Boers M" first="Maarten" last="Boers">Maarten Boers</name>
<affiliation wicri:level="3">
<country xml:lang="fr">Pays-Bas</country>
<wicri:regionArea>VU University Medical Center, Amsterdam</wicri:regionArea>
<placeName>
<settlement type="city">Amsterdam</settlement>
<region nuts="2" type="province">Hollande-Septentrionale</region>
</placeName>
</affiliation>
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</analytic>
<monogr></monogr>
<series>
<title level="j">Annals of the Rheumatic Diseases</title>
<title level="j" type="abbrev">Ann Rheum Dis</title>
<idno type="ISSN">0003-4967</idno>
<idno type="eISSN">1468-2060</idno>
<imprint>
<publisher>BMJ Publishing Group Ltd and European League Against Rheumatism</publisher>
<date type="published" when="2011-03">2011-03</date>
<biblScope unit="volume">70</biblScope>
<biblScope unit="issue">3</biblScope>
<biblScope unit="page" from="404">404</biblScope>
</imprint>
<idno type="ISSN">0003-4967</idno>
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<idno type="ISSN">0003-4967</idno>
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<keywords scheme="KwdEn" xml:lang="en">
<term>Abbott</term>
<term>Active disease</term>
<term>Aletaha</term>
<term>American college</term>
<term>Amgen</term>
<term>Arthritis</term>
<term>Arthritis rheum</term>
<term>Assessment scale</term>
<term>Boer</term>
<term>Boolean</term>
<term>Candidate remission</term>
<term>Cdai</term>
<term>Chronic</term>
<term>Clinical disease activity index</term>
<term>Clinical practice</term>
<term>Clinical remission</term>
<term>Clinical trial</term>
<term>Clinical trials</term>
<term>Combination therapy</term>
<term>Committee members</term>
<term>Consulting fees</term>
<term>Count remission</term>
<term>Definition</term>
<term>Disease activity</term>
<term>Disease activity index</term>
<term>Disease activity score</term>
<term>Erythrocyte sedimentation rate</term>
<term>European league</term>
<term>Face validity</term>
<term>Felson</term>
<term>Functional outcomes</term>
<term>Global assessment</term>
<term>Good outcome</term>
<term>Heijde</term>
<term>Highest level</term>
<term>Honorarium</term>
<term>Joint counts</term>
<term>Landew</term>
<term>Logistic regression</term>
<term>Methotrexate</term>
<term>Minimal disease activity</term>
<term>Monotherapy</term>
<term>Omeract</term>
<term>Other measures</term>
<term>Outcome measures</term>
<term>Phga</term>
<term>Physical function</term>
<term>Predictive validity</term>
<term>Ptga</term>
<term>Radiographic</term>
<term>Radiographic damage</term>
<term>Randomised</term>
<term>Reactant</term>
<term>Reactive</term>
<term>Reactive protein</term>
<term>Remission</term>
<term>Remission criteria</term>
<term>Residual</term>
<term>Residual disease activity</term>
<term>Rheum</term>
<term>Rheumatoid</term>
<term>Rheumatoid arthritis</term>
<term>Rheumatoid arthritis patients</term>
<term>Rheumatol</term>
<term>Rheumatology</term>
<term>Roche</term>
<term>Sdai</term>
<term>Smolen</term>
<term>Wyeth</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr">
<term>Chronique</term>
<term>Définition</term>
<term>Essai clinique</term>
<term>Polyarthrite rhumatoïde</term>
<term>Rhumatologie</term>
<term>Rémission</term>
</keywords>
<keywords scheme="Teeft" xml:lang="en">
<term>Abbott</term>
<term>Active disease</term>
<term>Aletaha</term>
<term>American college</term>
<term>Amgen</term>
<term>Arthritis</term>
<term>Arthritis rheum</term>
<term>Assessment scale</term>
<term>Boer</term>
<term>Boolean</term>
<term>Candidate remission</term>
<term>Cdai</term>
<term>Clinical disease activity index</term>
<term>Clinical practice</term>
<term>Clinical remission</term>
<term>Clinical trials</term>
<term>Combination therapy</term>
<term>Committee members</term>
<term>Consulting fees</term>
<term>Count remission</term>
<term>Disease activity</term>
<term>Disease activity index</term>
<term>Disease activity score</term>
<term>Erythrocyte sedimentation rate</term>
<term>European league</term>
<term>Face validity</term>
<term>Felson</term>
<term>Functional outcomes</term>
<term>Global assessment</term>
<term>Good outcome</term>
<term>Heijde</term>
<term>Highest level</term>
<term>Honorarium</term>
<term>Joint counts</term>
<term>Landew</term>
<term>Logistic regression</term>
<term>Methotrexate</term>
<term>Minimal disease activity</term>
<term>Monotherapy</term>
<term>Omeract</term>
<term>Other measures</term>
<term>Outcome measures</term>
<term>Phga</term>
<term>Physical function</term>
<term>Predictive validity</term>
<term>Ptga</term>
<term>Radiographic</term>
<term>Radiographic damage</term>
<term>Randomised</term>
<term>Reactant</term>
<term>Reactive</term>
<term>Reactive protein</term>
<term>Remission</term>
<term>Remission criteria</term>
<term>Residual</term>
<term>Residual disease activity</term>
<term>Rheum</term>
<term>Rheumatoid</term>
<term>Rheumatoid arthritis</term>
<term>Rheumatoid arthritis patients</term>
<term>Rheumatol</term>
<term>Rheumatology</term>
<term>Roche</term>
<term>Sdai</term>
<term>Smolen</term>
<term>Wyeth</term>
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<front>
<div type="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 analysed 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 (eg, 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 follow-up 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: (1) 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 (2) 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. The authors 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>
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<list>
<country>
<li>Australie</li>
<li>Autriche</li>
<li>Canada</li>
<li>Espagne</li>
<li>Finlande</li>
<li>France</li>
<li>Italie</li>
<li>Norvège</li>
<li>Pays-Bas</li>
<li>Royaume-Uni</li>
<li>Suisse</li>
<li>États-Unis</li>
</country>
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<li>Angleterre</li>
<li>Californie</li>
<li>Communauté de Madrid</li>
<li>District de Columbia</li>
<li>Grand Manchester</li>
<li>Hollande-Méridionale</li>
<li>Hollande-Septentrionale</li>
<li>Kansas</li>
<li>Languedoc-Roussillon</li>
<li>Maryland</li>
<li>Massachusetts</li>
<li>Occitanie (région administrative)</li>
<li>Ontario</li>
<li>Toscane</li>
<li>Victoria (État)</li>
<li>Vienne (Autriche)</li>
<li>État de New York</li>
<li>Île-de-France</li>
<li>Østlandet</li>
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<li>Amsterdam</li>
<li>Lawrence (Kansas)</li>
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<li>Montpellier</li>
<li>Oslo</li>
<li>Paris</li>
<li>Pise</li>
<li>Toronto</li>
<li>Vienne (Autriche)</li>
</settlement>
<orgName>
<li>Université de Manchester</li>
<li>Université de Melbourne</li>
<li>Université de Pise</li>
<li>Université de Toronto</li>
<li>Université du Kansas</li>
</orgName>
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<name sortKey="Zhang, Bin" sort="Zhang, Bin" uniqKey="Zhang B" first="Bin" last="Zhang">Bin Zhang</name>
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