ANALYSIS AT 2 YEARS OF AN INCEPTION COHORT OF EARLY RHEUMATOID ARTHRITIS: THE SONORA STUDY

Background: SONORA (Study of New-Onset Rheumatoid Arthritis) is a prospective 5-year, multicenter inception cohort study of North American patients diagnosed with new-onset rheumatoid arthritis (RA).Objectives: SONORA was designed to evaluate risk factors for clinical and health-related outcomes, as well as the impact of treatment in early RA.Methods: Patients diagnosed as having new onset RA (symptom >3 but <12 months) by a board-certified rheumatologist were recruited from 98 rheumatology practices. Clinical and laboratory data are collected by the enrolling rheumatologist at Baseline, 1, 2, and 5 years. Patients complete validated questionnaires (e.g., SF-36, HAQ, etc.) every 4 months.Results: A total of 1012 patients have been enrolled. Baseline (BL) to Year 2 data are available for 414 patients to date. Patients are predominately female (75%) and Caucasian (90%), with mean age 53 years (range 19-85) and median duration of RA signs and symptoms of 190 days at the time of BL evaluation. Sixty percent (60%) of patients had received traditional disease-modifying antirheumatic drugs (DMARDs) at BL compared to 78% at Year 2. Eighty-two patients (20%) were on a biologic at Year 2 (infliximab, 40; etanercept, 29; anakinra, 5; adalimumab, 8). Disease activity decreased during the 2 years after presentation, evidenced by 41%, 24% and 7% of patients achieving an ACR 20/50/70, respectively. Improvement was greatest in swollen joint count, global disease activity (physician), and morning stiffness. HAQ and patient assessments of improvement were more modest. Parameter Baseline Year 2 Mean change from BL Mean (SD) Mean (SD) (median % change) Tender joint count (0-68) 17.3 (13.8) 7.8 (10.9) -9.5 (-40%) Swollen joint count (0-66) 13.1(10.4) 6.5 (9.2) -6.6 (-70%) HAQ score (0-3) 1.00 (0.71) 0.70 (0.70) -0.26 (-29%) C-reactive protein (mg/dL) 4.9 (11.6) 2.5 (4.6) -2.4 (0%) Phys. Global Dis Act (0-10) 4.9 (2.1) 2.8 (1.7) -2.0 (-50%) Pt. Global Dis Act (0-10) 4.7 (2.4) 3.5 (2.2) -1.3 (-25%) Pt's Assessment Pain (0-10) 4.8 (2.4) 3.7 (2.3) -1.1 (-22%) Morning Stiffness (minutes) 87.6 (121.4) 43.2 (69.3) -44.3 (-50%) ld]Conclusion: At the 2-year follow-up, 78% of the patients were receiving traditional DMARDs and 20% were on a biologic DMARD. The overall improvement in disease activity was modest compared to data reported in controlled trials, though improved over previously presented Year 1 data. This improvement may be due to increased use of biologic DMARDs during the second year of observation. Patient-reported data demonstrate more modest improvement that physician-reported assessments. This real-world, patient-reported data represents an important benchmark to measure treatment effectiveness as newer agents are introduced into community practice.Citation: , volume , supplement , year 2004, page Session: Advances in RA risk and comorbility