RT Journal Article
SR Electronic
T1 Minimal disease activity for rheumatoid arthritis: a preliminary definition.
JF The Journal of Rheumatology
JO J Rheumatol
FD The Journal of Rheumatology
SP 2016
OP 2024
VO 32
IS 10
A1 George A Wells
A1 Maarten Boers
A1 Beverley Shea
A1 Peter M Brooks
A1 Lee S Simon
A1 C Vibeke Strand
A1 Daniel Aletaha
A1 Jennifer J Anderson
A1 Claire Bombardier
A1 Maxime Dougados
A1 Paul Emery
A1 David T Felson
A1 Jaap Fransen
A1 Dan E Furst
A1 Johanna M W Hazes
A1 Kent R Johnson
A1 John R Kirwan
A1 Robert B M Landewé
A1 Marissa N D Lassere
A1 Kaleb Michaud
A1 Maria Suarez-Almazor
A1 Alan J Silman
A1 Josef S Smolen
A1 Desiree M F M Van der Heijde
A1 Piet L C M van Riel
A1 Fred Wolfe
A1 Peter S Tugwell
YR 2005
UL http://www.jrheum.org/content/32/10/2016.abstract
AB 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 cutpoints 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 < or = 2.85; * The core set definition places patients in MDA when they meet 5 of 7 criteria: (1) Pain (0-10) < or = 2; (2) Swollen joint count (0-28) < or = 1; (3) Tender joint count (0-28) < or = 1; (4) Health Assessment Questionnaire (HAQ, 0-3) < or = 0.5; (5) Physician global assessment of disease activity (0-10) < or = 1.5; (6) Patient global assessment of disease activity (0-10) < or = 2; (7) ESR < or = 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.