American College of Rheumatology/European League Against Rheumatism provisional definition of remission in rheumatoid arthritis for clinical trials

David T. Felson, Josef S. Smolen, George Wells, Bin Zhang, Lilian H D Van Tuyl, Julia Funovits, Daniel Aletaha, Cornelia F. Allaart, Joan Bathon, Stefano Bombardieri, Peter Brooks, Andrew Brown, Marco Matucci-Cerinic, Hyon Choi, Bernard Combe, Maarten De Wit, Maxime Dougados, Paul Emery, Daniel Furst, Juan Gomez-Reino & 24 others Gillian Hawker, Edward Keystone, Dinesh Khanna, John Kirwan, Tore K. Kvien, Robert Landewé, 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, Alan Tyndall, Desirée Van Der Heijde, Suzan Verstappen, Barbara White, Frederick Wolfe, Angela Zink, Maarten Boers

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Pages (from-to)404-413
Number of pages10
JournalAnnals of the Rheumatic Diseases
Volume70
Issue number3
DOIs
StatePublished - Mar 2011

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Rheumatoid Arthritis
Joints
Clinical Trials
Outcome Assessment (Health Care)
C-Reactive Protein
Committee Membership
Acute-Phase Proteins
Joint Diseases
Rheumatology

ASJC Scopus subject areas

  • Rheumatology
  • Immunology
  • Biochemistry, Genetics and Molecular Biology(all)
  • Immunology and Allergy

Cite this

American College of Rheumatology/European League Against Rheumatism provisional definition of remission in rheumatoid arthritis for clinical trials. / 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.

In: Annals of the Rheumatic Diseases, Vol. 70, No. 3, 03.2011, p. 404-413.

Research output: Contribution to journalArticle

Felson, DT, Smolen, JS, Wells, G, Zhang, B, Van Tuyl, LHD, Funovits, J, Aletaha, D, Allaart, CF, Bathon, J, Bombardieri, S, Brooks, P, Brown, A, Matucci-Cerinic, M, Choi, H, Combe, B, De Wit, M, Dougados, M, Emery, P, Furst, D, Gomez-Reino, J, Hawker, G, Keystone, E, Khanna, D, Kirwan, J, Kvien, TK, Landewé, R, Listing, J, Michaud, K, Martin-Mola, E, Montie, P, Pincus, T, Richards, P, Siegel, JN, Simon, LS, Sokka, T, Strand, V, Tugwell, P, Tyndall, A, Van Der Heijde, D, Verstappen, S, White, B, Wolfe, F, Zink, A & Boers, M 2011, 'American College of Rheumatology/European League Against Rheumatism provisional definition of remission in rheumatoid arthritis for clinical trials', Annals of the Rheumatic Diseases, vol. 70, no. 3, pp. 404-413. https://doi.org/10.1136/ard.2011.149765
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. / American College of Rheumatology/European League Against Rheumatism provisional definition of remission in rheumatoid arthritis for clinical trials. In: Annals of the Rheumatic Diseases. 2011 ; Vol. 70, No. 3. pp. 404-413.
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TY - JOUR

T1 - American College of Rheumatology/European League Against Rheumatism provisional definition of remission in rheumatoid arthritis for clinical trials

AU - Felson, David T.

AU - Smolen, Josef S.

AU - Wells, George

AU - Zhang, Bin

AU - Van Tuyl, Lilian H D

AU - Funovits, Julia

AU - Aletaha, Daniel

AU - Allaart, Cornelia F.

AU - Bathon, Joan

AU - Bombardieri, Stefano

AU - Brooks, Peter

AU - Brown, Andrew

AU - Matucci-Cerinic, Marco

AU - Choi, Hyon

AU - Combe, Bernard

AU - De Wit, Maarten

AU - Dougados, Maxime

AU - Emery, Paul

AU - Furst, Daniel

AU - Gomez-Reino, Juan

AU - Hawker, Gillian

AU - Keystone, Edward

AU - Khanna, Dinesh

AU - Kirwan, John

AU - Kvien, Tore K.

AU - Landewé, Robert

AU - Listing, Joachim

AU - Michaud, Kaleb

AU - Martin-Mola, Emilio

AU - Montie, Pamela

AU - Pincus, Theodore

AU - Richards, Pamela

AU - Siegel, Jeffrey N.

AU - Simon, Lee S.

AU - Sokka, Tuulikki

AU - Strand, Vibeke

AU - Tugwell, Peter

AU - Tyndall, Alan

AU - Van Der Heijde, Desirée

AU - Verstappen, Suzan

AU - White, Barbara

AU - Wolfe, Frederick

AU - Zink, Angela

AU - Boers, Maarten

PY - 2011/3

Y1 - 2011/3

N2 - 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.

AB - 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.

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