Background/Purpose: Rheumatoid arthritis (RA) is associated with unpredictable episodes of disease worsening that may prompt consideration of treatment change. Core RA Flare domains have been ratified by OMERACT, but the optimal PRO instruments have not been determined. PROMIS offers population-normed measures to assess physical, emotional, and social health, including RA Flare domains. PROMIS use in RA is limited and has not been evaluated for flare detection.

Methods: Data are from the baseline visit of the first 125 RA pts enrolled in an ongoing study integrating PROs into routine RA care. Pts were asked whether they were in a significant RA flare, flare duration and severity, and completed selected PROMIS CATs (pain, fatigue, physical function, and social roles/activities), along with MHAQ, pain, fatigue, pt global VAS, change from last visit and pt acceptable symptom state. MD global and joint counts were also recorded. Flare vs. no-flare groups were compared using t-tests and χ².

Results: Participants (N=126) were mostly female (79%) and white (86%) with a mean (SD) age of 56 (13) and RA duration of 12 (9) yr; 10% were diagnosed ≤ 2 yr. 20% reported a current flare with a mean severity of 6.0 (2.5)(0=none; 10=worst); 52% reported duration >14 d. Compared to others, flaring pts were more likely to rate RA worse than the prior visit (OR 7.6; 95% CI 2.9, 19.7) and current symptom state unacceptable (OR 5.6; 95% CI 2.2, 14.4). Flare was not associated with age, sex, race, RA duration, or education. Pts reporting flare had significantly higher PROMIS pain and fatigue scores, and lower physical function as well as participation in and satisfaction with social roles and activities (Table). Traditional PROs (pain, fatigue, pt global VAS, MHAQ) and clinical disease activity indicators (CDAI, MD Global, joint counts) were also significantly higher in the flare group.

Conclusion: Patient reports of RA flares are associated with significantly higher PROMIS scores, legacy measures and clinical disease activity indicators, providing evidence of convergent validity of PROMIS instruments. Results suggest PROMIS measures can assess RA Flare domains and identify pts in flare, with shifts of 0.4-1 SD between groups. Prospective studies are ongoing to assess responsiveness of PROMIS for RA improvement and worsening. Beyond flare detection, selected PROMIS measures may aid in RA self-monitoring, and in the case of worsening, could signal the need for additional clinical assessment.