Minimal disease activity for rheumatoid arthritis

A preliminary definition

George A. Wells, Maarten Boers, Beverley Shea, Peter M. Brooks, Lee S. Simon, C. Vibeke Strand, Daniel Aletaha, Jennifer J. Anderson, Claire Bombardier, Maxime Dougados, Paul Emery, David T. Felson, Jaap Fransen, Dan E. Furst, Johanna M.W. Hazes, Kent R. Johnson, John R. Kirwan, Robert B.M. Landewé, Marissa N.D. Lassere, Kaleb D Michaud & 7 others Maria Suarez-Almazor, Alan J. Silman, Josef S. Smolen, Desiree M.F.M. Van Der Heijde, Piet L.C.M. Van Riel, Fred Wolfe, Peter S. Tugwell

Research output: Contribution to journalArticle

141 Citations (Scopus)

Abstract

Agreement on response criteria in rheumatoid arthritis (RA) has allowed better standardization and interpretation of clinical trial reports. With recent advances in therapy, the proportion of patients achieving a satisfactory state of minimal disease activity (MDA) is becoming a more important measure with which to compare different treatment strategies. The threshold for MDA is between high disease activity and remission and, by definition, anyone in remission will also be in MDA. True remission is still rare in RA; in addition, the American College of Rheumatology definition is difficult to apply in the context of trials. Participants at OMERACT 6 in 2002 agreed on a conceptual definition of minimal disease activity (MDA): "that state of disease activity deemed a useful target of treatment by both the patient and the physician, given current treatment possibilities and limitations." To prepare for a preliminary operational definition of MDA for use in clinical trials, we asked rheumatologists to assess 60 patient profiles describing real RA patients seen in routine clinical practice. Based on their responses, several candidate definitions for MDA were designed and discussed at the OMERACT 7 in 2004. Feedback from participants and additional on-site analyses in a cross-sectional database allowed the formulation of 2 preliminary, equivalent definitions of MDA: one based on the Disease Activity Score 28 (DAS28) index, and one based on meeting outpoints in 5 out the 7 WHO/ILAR core set measures. Researchers applying these definitions first need to choose whether to use the DAS28 or the core set definition, because although each selects a similar proportion in a population, these are not always the same patients. In both MDA definitions, an initial decision node places all patients in MDA who have a tender joint count of 0 and a swollen joint count of 0, and an erythrocyte sedimentation rate (ESR) no greater than 10 mm. If this condition is not met: The DAS28 definition places patients in MDA when DAS28 ≤ 2.85 The core set definition places patients in MDA when they meet 5 of 7 criteria: (1) Pain (0-10) ≤ 2; (2) Swollen joint count (0-28) ≤ 1; (3) Tender joint count (0-28) ≤ 1; (4) Health Assessment Questionnaire (HAQ, 0-3) ≤ 0.5; (5) Physician global assessment of disease activity (0-10) ≤ 1.5; (6) Patient global assessment of disease activity (0-10) ≤ 2; (7) ESR ≤ 20. This set of 2 definitions gained approval of 73% of the attendees. These (and other) definitions will now be subject to further validation in other databases.

Original languageEnglish (US)
Pages (from-to)2016-2024
Number of pages9
JournalJournal of Rheumatology
Volume32
Issue number10
StatePublished - Jan 1 2005

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Rheumatoid Arthritis
Joints
Blood Sedimentation
ametantrone
Clinical Trials
Databases
Physicians
Therapeutics

Keywords

  • Clinical trials
  • Minimal disease activity
  • Outcome measures
  • Rheumatoid arthritis
  • Survey

ASJC Scopus subject areas

  • Rheumatology
  • Immunology and Allergy
  • Immunology

Cite this

Wells, G. A., Boers, M., Shea, B., Brooks, P. M., Simon, L. S., Strand, C. V., ... Tugwell, P. S. (2005). Minimal disease activity for rheumatoid arthritis: A preliminary definition. Journal of Rheumatology, 32(10), 2016-2024.

Minimal disease activity for rheumatoid arthritis : A preliminary definition. / Wells, George A.; Boers, Maarten; Shea, Beverley; Brooks, Peter M.; Simon, Lee S.; Strand, C. Vibeke; Aletaha, Daniel; Anderson, Jennifer J.; Bombardier, Claire; Dougados, Maxime; Emery, Paul; Felson, David T.; Fransen, Jaap; Furst, Dan E.; Hazes, Johanna M.W.; Johnson, Kent R.; Kirwan, John R.; Landewé, Robert B.M.; Lassere, Marissa N.D.; Michaud, Kaleb D; Suarez-Almazor, Maria; Silman, Alan J.; Smolen, Josef S.; Van Der Heijde, Desiree M.F.M.; Van Riel, Piet L.C.M.; Wolfe, Fred; Tugwell, Peter S.

In: Journal of Rheumatology, Vol. 32, No. 10, 01.01.2005, p. 2016-2024.

Research output: Contribution to journalArticle

Wells, GA, Boers, M, Shea, B, Brooks, PM, Simon, LS, Strand, CV, Aletaha, D, Anderson, JJ, Bombardier, C, Dougados, M, Emery, P, Felson, DT, Fransen, J, Furst, DE, Hazes, JMW, Johnson, KR, Kirwan, JR, Landewé, RBM, Lassere, MND, Michaud, KD, Suarez-Almazor, M, Silman, AJ, Smolen, JS, Van Der Heijde, DMFM, Van Riel, PLCM, Wolfe, F & Tugwell, PS 2005, 'Minimal disease activity for rheumatoid arthritis: A preliminary definition', Journal of Rheumatology, vol. 32, no. 10, pp. 2016-2024.
Wells GA, Boers M, Shea B, Brooks PM, Simon LS, Strand CV et al. Minimal disease activity for rheumatoid arthritis: A preliminary definition. Journal of Rheumatology. 2005 Jan 1;32(10):2016-2024.
Wells, George A. ; Boers, Maarten ; Shea, Beverley ; Brooks, Peter M. ; Simon, Lee S. ; Strand, C. Vibeke ; Aletaha, Daniel ; Anderson, Jennifer J. ; Bombardier, Claire ; Dougados, Maxime ; Emery, Paul ; Felson, David T. ; Fransen, Jaap ; Furst, Dan E. ; Hazes, Johanna M.W. ; Johnson, Kent R. ; Kirwan, John R. ; Landewé, Robert B.M. ; Lassere, Marissa N.D. ; Michaud, Kaleb D ; Suarez-Almazor, Maria ; Silman, Alan J. ; Smolen, Josef S. ; Van Der Heijde, Desiree M.F.M. ; Van Riel, Piet L.C.M. ; Wolfe, Fred ; Tugwell, Peter S. / Minimal disease activity for rheumatoid arthritis : A preliminary definition. In: Journal of Rheumatology. 2005 ; Vol. 32, No. 10. pp. 2016-2024.
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