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

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. Me... Full description

Journal Title: Annals of the Rheumatic Diseases 2011, Vol.70 (3), p.404-413
Main Author: Felson, David T
Other Authors: Smolen, Josef S , Wells, George , Zhang, Bin , van Tuyl, Lilian H D , Funovits, Julia , Aletaha, Daniel , Allaart, Cornelia F , Bathon, Joan , Bombardieri, Stefano , Brooks, Peter , Brown, Andrew , Matucci-Cerinic, Marco , Choi, Hyon , Combe, Bernard , de Wit, Maarten , Dougados, Maxime , Emery, Paul , Furst, Daniel , Gomez-Reino, Juan , Hawker, Gillian , Keystone, Edward , Khanna, Dinesh , Kirwan, John , Kvien, Tore K , Landewé, Robert , Listing, Joachim , Michaud, Kaleb , Martin-Mola, Emilio , Montie, Pamela , Pincus, Theodore , Richards, Pamela , Siegel, Jeffrey N , Simon, Lee S , Sokka, Tuulikki , Strand, Vibeke , Tugwell, Peter , Tyndall, Alan , van der Heijde, Desirée , Verstappen, Suzan , White, Barbara , Wolfe, Frederick , Zink, Angela , Boers, Maarten
Format: Electronic Article Electronic Article
Language: English
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Publisher: London: BMJ Publishing Group Ltd and European League Against Rheumatism
ID: ISSN: 0003-4967
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title: American College of Rheumatology/European League Against Rheumatism Provisional Definition of Remission in Rheumatoid Arthritis for Clinical Trials
format: Article
creator:
  • Felson, David T
  • Smolen, Josef S
  • Wells, George
  • Zhang, Bin
  • van Tuyl, Lilian H D
  • Funovits, Julia
  • Aletaha, Daniel
  • Allaart, Cornelia F
  • Bathon, Joan
  • Bombardieri, Stefano
  • Brooks, Peter
  • Brown, Andrew
  • Matucci-Cerinic, Marco
  • Choi, Hyon
  • Combe, Bernard
  • de Wit, Maarten
  • Dougados, Maxime
  • Emery, Paul
  • Furst, Daniel
  • Gomez-Reino, Juan
  • Hawker, Gillian
  • Keystone, Edward
  • Khanna, Dinesh
  • Kirwan, John
  • Kvien, Tore K
  • Landewé, Robert
  • Listing, Joachim
  • Michaud, Kaleb
  • Martin-Mola, Emilio
  • Montie, Pamela
  • Pincus, Theodore
  • Richards, Pamela
  • Siegel, Jeffrey N
  • Simon, Lee S
  • Sokka, Tuulikki
  • Strand, Vibeke
  • Tugwell, Peter
  • Tyndall, Alan
  • van der Heijde, Desirée
  • Verstappen, Suzan
  • White, Barbara
  • Wolfe, Frederick
  • Zink, Angela
  • Boers, Maarten
subjects:
  • Clinical medicine
  • Clinical trials
  • Committees
  • Pharmaceutical industry
  • Researchers
  • Rheumatism
  • Rheumatoid arthritis
  • Rheumatology
  • Studies
ispartof: Annals of the Rheumatic Diseases, 2011, Vol.70 (3), p.404-413
description: 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
language: eng
source:
identifier: ISSN: 0003-4967
fulltext: no_fulltext
issn:
  • 0003-4967
  • 1468-2060
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titleAmerican College of Rheumatology/European League Against Rheumatism Provisional Definition of Remission in Rheumatoid Arthritis for Clinical Trials
creatorFelson, David T ; Smolen, Josef S ; Wells, George ; Zhang, Bin ; van Tuyl, Lilian H D ; Funovits, Julia ; Aletaha, Daniel ; Allaart, Cornelia F ; Bathon, Joan ; Bombardieri, Stefano ; Brooks, Peter ; Brown, Andrew ; Matucci-Cerinic, Marco ; Choi, Hyon ; Combe, Bernard ; de Wit, Maarten ; Dougados, Maxime ; Emery, Paul ; Furst, Daniel ; Gomez-Reino, Juan ; Hawker, Gillian ; Keystone, Edward ; Khanna, Dinesh ; Kirwan, John ; Kvien, Tore K ; Landewé, Robert ; Listing, Joachim ; Michaud, Kaleb ; Martin-Mola, Emilio ; Montie, Pamela ; Pincus, Theodore ; Richards, Pamela ; Siegel, Jeffrey N ; Simon, Lee S ; Sokka, Tuulikki ; Strand, Vibeke ; Tugwell, Peter ; Tyndall, Alan ; van der Heijde, Desirée ; Verstappen, Suzan ; White, Barbara ; Wolfe, Frederick ; Zink, Angela ; Boers, Maarten
creatorcontribFelson, David T ; Smolen, Josef S ; Wells, George ; Zhang, Bin ; van Tuyl, Lilian H D ; Funovits, Julia ; Aletaha, Daniel ; Allaart, Cornelia F ; Bathon, Joan ; Bombardieri, Stefano ; Brooks, Peter ; Brown, Andrew ; Matucci-Cerinic, Marco ; Choi, Hyon ; Combe, Bernard ; de Wit, Maarten ; Dougados, Maxime ; Emery, Paul ; Furst, Daniel ; Gomez-Reino, Juan ; Hawker, Gillian ; Keystone, Edward ; Khanna, Dinesh ; Kirwan, John ; Kvien, Tore K ; Landewé, Robert ; Listing, Joachim ; Michaud, Kaleb ; Martin-Mola, Emilio ; Montie, Pamela ; Pincus, Theodore ; Richards, Pamela ; Siegel, Jeffrey N ; Simon, Lee S ; Sokka, Tuulikki ; Strand, Vibeke ; Tugwell, Peter ; Tyndall, Alan ; van der Heijde, Desirée ; Verstappen, Suzan ; White, Barbara ; Wolfe, Frederick ; Zink, Angela ; Boers, Maarten
descriptionObjective 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.
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languageeng
publisherLondon: BMJ Publishing Group Ltd and European League Against Rheumatism
subjectClinical medicine ; Clinical trials ; Committees ; Pharmaceutical industry ; Researchers ; Rheumatism ; Rheumatoid arthritis ; Rheumatology ; Studies
ispartofAnnals of the Rheumatic Diseases, 2011, Vol.70 (3), p.404-413
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0Felson, David T
1Smolen, Josef S
2Wells, George
3Zhang, Bin
4van Tuyl, Lilian H D
5Funovits, Julia
6Aletaha, Daniel
7Allaart, Cornelia F
8Bathon, Joan
9Bombardieri, Stefano
10Brooks, Peter
11Brown, Andrew
12Matucci-Cerinic, Marco
13Choi, Hyon
14Combe, Bernard
15de Wit, Maarten
16Dougados, Maxime
17Emery, Paul
18Furst, Daniel
19Gomez-Reino, Juan
20Hawker, Gillian
21Keystone, Edward
22Khanna, Dinesh
23Kirwan, John
24Kvien, Tore K
25Landewé, Robert
26Listing, Joachim
27Michaud, Kaleb
28Martin-Mola, Emilio
29Montie, Pamela
30Pincus, Theodore
31Richards, Pamela
32Siegel, Jeffrey N
33Simon, Lee S
34Sokka, Tuulikki
35Strand, Vibeke
36Tugwell, Peter
37Tyndall, Alan
38van der Heijde, Desirée
39Verstappen, Suzan
40White, Barbara
41Wolfe, Frederick
42Zink, Angela
43Boers, Maarten
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0American College of Rheumatology/European League Against Rheumatism Provisional Definition of Remission in Rheumatoid Arthritis for Clinical Trials
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descriptionObjective 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.
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7Allaart, Cornelia F
8Bathon, Joan
9Bombardieri, Stefano
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16Dougados, Maxime
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18Furst, Daniel
19Gomez-Reino, Juan
20Hawker, Gillian
21Keystone, Edward
22Khanna, Dinesh
23Kirwan, John
24Kvien, Tore K
25Landewé, Robert
26Listing, Joachim
27Michaud, Kaleb
28Martin-Mola, Emilio
29Montie, Pamela
30Pincus, Theodore
31Richards, Pamela
32Siegel, Jeffrey N
33Simon, Lee S
34Sokka, Tuulikki
35Strand, Vibeke
36Tugwell, Peter
37Tyndall, Alan
38van der Heijde, Desirée
39Verstappen, Suzan
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titleAmerican College of Rheumatology/European League Against Rheumatism Provisional Definition of Remission in Rheumatoid Arthritis for Clinical Trials
authorFelson, David T ; Smolen, Josef S ; Wells, George ; Zhang, Bin ; van Tuyl, Lilian H D ; Funovits, Julia ; Aletaha, Daniel ; Allaart, Cornelia F ; Bathon, Joan ; Bombardieri, Stefano ; Brooks, Peter ; Brown, Andrew ; Matucci-Cerinic, Marco ; Choi, Hyon ; Combe, Bernard ; de Wit, Maarten ; Dougados, Maxime ; Emery, Paul ; Furst, Daniel ; Gomez-Reino, Juan ; Hawker, Gillian ; Keystone, Edward ; Khanna, Dinesh ; Kirwan, John ; Kvien, Tore K ; Landewé, Robert ; Listing, Joachim ; Michaud, Kaleb ; Martin-Mola, Emilio ; Montie, Pamela ; Pincus, Theodore ; Richards, Pamela ; Siegel, Jeffrey N ; Simon, Lee S ; Sokka, Tuulikki ; Strand, Vibeke ; Tugwell, Peter ; Tyndall, Alan ; van der Heijde, Desirée ; Verstappen, Suzan ; White, Barbara ; Wolfe, Frederick ; Zink, Angela ; Boers, Maarten
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18Furst, Daniel
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23Kirwan, John
24Kvien, Tore K
25Landewé, Robert
26Listing, Joachim
27Michaud, Kaleb
28Martin-Mola, Emilio
29Montie, Pamela
30Pincus, Theodore
31Richards, Pamela
32Siegel, Jeffrey N
33Simon, Lee S
34Sokka, Tuulikki
35Strand, Vibeke
36Tugwell, Peter
37Tyndall, Alan
38van der Heijde, Desirée
39Verstappen, Suzan
40White, Barbara
41Wolfe, Frederick
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8Bathon, Joan
9Bombardieri, Stefano
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11Brown, Andrew
12Matucci-Cerinic, Marco
13Choi, Hyon
14Combe, Bernard
15de Wit, Maarten
16Dougados, Maxime
17Emery, Paul
18Furst, Daniel
19Gomez-Reino, Juan
20Hawker, Gillian
21Keystone, Edward
22Khanna, Dinesh
23Kirwan, John
24Kvien, Tore K
25Landewé, Robert
26Listing, Joachim
27Michaud, Kaleb
28Martin-Mola, Emilio
29Montie, Pamela
30Pincus, Theodore
31Richards, Pamela
32Siegel, Jeffrey N
33Simon, Lee S
34Sokka, Tuulikki
35Strand, Vibeke
36Tugwell, Peter
37Tyndall, Alan
38van der Heijde, Desirée
39Verstappen, Suzan
40White, Barbara
41Wolfe, Frederick
42Zink, Angela
43Boers, Maarten
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abstractObjective 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.
copLondon
pubBMJ Publishing Group Ltd and European League Against Rheumatism
doi10.1136/ard.2011.149765
oafree_for_read