Abstract: Definition of Flare in RA

August 15, 2009

Developing a Standardized Definition for Disease " Flare " in Rheumatoid Arthritis

(OMERACT 9 Special Interest Group)

Abstract

Objective Traditional outcome measures in randomized controlled trials (RCT)

include well-established response criteria as well as ACR EULAR responses using

Disease Activity Score 44 (DAS44)/DAS28 to assess improvement; however, a

measure to assess worsening of disease has yet to be developed. This special

interest group (SIG) was established to develop an evidence-based,

consensus-driven standard definition of " flare " in rheumatoid arthritis (RA).

Methods At OMERACT 8, the need for a standardized definition of RA flare was

recognized; interested individuals developed a proposal to form a SIG. A

literature review was performed to identify publications and abstracts with

flare definitions applied in RA, JIA, and lupus RCT as well as concerning

patient perspectives on disease worsening. A SIG was held at OMERACT 9 with

breakout sessions for patients and investigators.

Results The RA flare SIG was attended by about 120 participants, including 11

patients. Patients and investigators held separate breakout sessions to discuss

various aspects of disease worsening. The following consensus was obtained at

OMERACT 9: a working definition of flare should indicate worsening of disease

activity (88%), persistence, and duration as critical elements (77%), and

consideration of change or increase in therapy (74%).

Conclusion A working definition of RA flare was developed based on these votes:

flare is any worsening of disease activity that would, if persistent, in most

cases lead to initiation or change of therapy; and a flare represents a cluster

of symptoms of sufficient duration and intensity to require initiation, change,

or increase in therapy. Using this working definition, evaluation of candidate

domains will be conducted via Delphi exercise and further informed by patient

focus groups. Validation of candidate definitions in appropriate RCT will be

required.

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Annette - Toronto

Growing older is mandatory. Growing up is optional.

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