Background The word “flare” is often used to describe episodes of disease worsening in RA, but no established definition of flare in RA currently exists. The OMERACT RA Flare Group has proposed a preliminary working definition of flare. Core domains for assessment of flare have been identified by patients (pts) and health care professionals through Delphi exercises (Pain, Function, Swollen Joints, Tender Joints, Stiffness, Participation, Patient Global Assessment, Self-Management, Fatigue)1.
Objectives To compare changes in RA flare core domain variables in RA pts with and without flare, defined as patient-reported disease worsening.
Methods Data for the analyses were provided by the NOR-DMARD register, an ongoing longitudinal observational study of pts starting a new DMARD regimen. We restricted the current analyses to pts who considered themselves “improved” or “much improved” at 3 months after start of treatment (answered on a 5-point Likert scale: “much improved” thru “much worse”). Flare was defined as pt-reported worsening at 6 months (“worse” or “much worse”). Additional analyses defined flare based on step-up of DMARD/systemic corticosteroid treatment, or combinations of treatment change and pt-reported worsening. Three-to-6-month changes in variables representing the RA flare core domains, as well as the remaining components of the ACR core set and 3 composite disease activity measures (DAS28, SDAI, CDAI), were compared in the flare/no-flare pts, and expressed as standardized mean differences (SMD) with 95% CI.
Results Of 1457 pts eligible for analyses, 1195 pts had available 6-month follow-up data (MTX n=727, other non-biologic DMARDs n=224, TNF inhibitor n=229, other biologics n=15). Mean (SD) disease duration 6.3 (9.7) yrs; age 55.0 (13.7) yrs; RF+ 68%; female 71%; baseline DAS28 4.9 (1.4). There were 79 pt-reported flares at 6 months. The overlap with flare defined by treatment change (162 flares) was only 35 patients, indicating that the two flare definitions are different. Only results for pt-reported flare are shown (table) as the SMDs for treatment-related flare were small to moderate.
Conclusions The working definition of flare based on pt-reported worsening discriminated well between pts with and without worsening in flare domains related to pain and stiffness. Pt-reported flares were sometimes not associated with change in treatment.
Bartlett SJ, et al. Consensus Among Patients and Health Care Professionals for Essential Domains to Assess Disease Flares in Rheumatoid Arthritis: Results of Final OMERACT Delphi. Arthritis Rheum 2011;63(suppl):128.
Disclosure of Interest None Declared