Rheumatology
Rheumatoid Arthritis
Patient Reports Aid in Development of Rheumatoid Arthritis Flare Criteria
Overview
Increasingly, leaders in the field have been calling for clinical trials in rheumatoid arthritis (RA) to examine and to report on not merely inflammation, but also those aspects of the disease that are of the highest importance to patients: pain, fatigue, quality of life, and social interactions. Many trials are beginning to investigate these patient-reported outcomes (PROs), and the importance of patient-reported data is widely recognized. Here, Daniel E. Furst, MD, describes the influence of PROs on the development of flare criteria.
Expert Commentary
Daniel E. Furst, MD
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“I have been particularly struck by some of the patient-reported data. In addition to profound impacts on activities of daily living, there are also subjective comments from patients such as, ‘It makes me feel like I want to curl up in a corner.’ These patients truly understand those needs, and we really have to spend more time in these areas. ”
Disease flares, or episodes of clinically important worsening, are common in patients with RA, with up to 57% reporting a flare at or between visits. We’ve been working on developing some flare criteria, and I’ve had the pleasure of serving on the OMERACT (Outcome Measures in Rheumatology) Rheumatoid Arthritis Flare Group. The Flare Group is a diverse group of international researchers, clinicians, patient research partners, and others working to create a new tool to identify and measure significant RA flares from the patient perspective. Part of our process involved interviews with patients and clinicians to help assess content validity, utility, and meaningfulness of RA Flare Questionnaire scores. I have been particularly struck by some of the patient-reported data. In addition to profound impacts on activities of daily living, there are also subjective comments from patients such as, “It makes me feel like I want to curl up in a corner.” These patients truly understand those needs, and we really have to spend more time in these areas. All of my patients complete, at the very least, the Health Assessment Questionnaire Disability Index. And, certainly, that would be a minimum, in my view.
References
Bartlett SJ, Barbic SP, Bykerk VP, et al. Content and construct validity, reliability, and responsiveness of the Rheumatoid Arthritis Flare Questionnaire: OMERACT 2016 Workshop Report. J Rheumatol. 2017;44(10):1536-1543.
Bartlett SJ, Bykerk VP, Cooksey R, et al. Feasibility and domain validation of Rheumatoid Arthritis (RA) Flare Core Domain Set: report of the OMERACT 2014 RA Flare Group Plenary. J Rheumatol. 2015;42(11):2185-2189.
Bykerk VP, Shadick N, Frits M, et al. Flares in rheumatoid arthritis: frequency and management. A report from the BRASS registry. J Rheumatol. 2014;41(2):227-234.
Emery P, Sebba A, Huizinga TW. Biologic and oral disease-modifying antirheumatic drug monotherapy in rheumatoid arthritis. Ann Rheum Dis. 2013;72(12):1897-1904.
Lie E, Woodworth TG, Christensen R, et al; OMERACT RA Flare Working Group. Validation of OMERACT preliminary rheumatoid arthritis flare domains in the NOR-DMARD study. Ann Rheum Dis. 2014;73(10):1781-1787.