OP0042 ANALYSIS AT 2 YEARS OF AN INCEPTION COHORT OF EARLY RHEUMATOID ARTHRITIS: THE SONORA STUDY
M.H. Weisman, C. Bombardier, E.M. Massarotti, P.K. Gregersen, G.M. Fava, J.D. Kent: Los Angeles, United States

SONORA (Study of New Onset Rheumatoid Arthritis) is a five year observational study of approximately 1000 RA patients from 98 clinical centers in the U.S. and Canada designed to assess the clinical, biological, epidemiological, and sociological factors affecting disease progression. Patients are enrolled based only on the presence of inflammatory synovitis with symptoms greater than 3 months and less than 12 months. SONORA one year data was presented at EULAR 2003 along with a more detailed description of the study design and methods. At EULAR 2004, year two data were presented.

Results: Of 1012 enrolled patients, 414 patients had completed year two assessments. By year two, 78% of patients were receiving DMARDS, compared with 60% with DMARD use at baseline. 20% were prescribed a biologic DMARD at year two, compared with 11% prescribed biologics at year one (49% infliximab, 35% etanercept, 10% adalimumab, 6% anakinra).

At year two, 41% of patients had achieved an ACR 20 response, 24% an ACR 50 response, and 7% an ACR 70 response. The categories with the greatest overall median percentage improvements were in tender and swollen joints (40% and 70% median percent improvements from baseline, respectively), Physician Global Assessment (50% improvement from baseline), and minutes of morning stiffness (50% improvement from baseline). Median percent changes in disability as assessed by HAQ score (29% improvement from baseline), and patient assessments (Patient Global Assessment: 25% improvement from baseline, Patient Assessment of Pain: 22% improvement from baseline) were not as robust. C-reactive protein demonstrated a mean decrease of 2.4 mg/dl from baseline by year two.

Radiographic progression was observed in a total of 32% of patients from baseline (joint space narrowing in 19%, erosions in 25%). There was no difference in the proportion of patients with radiographic progression between those treated with and without biologics. Of note, patients treated with biologics tended to have higher disease activity than those treated with non-biologic therapies.

Conclusions: In a cohort of early synovitis patients observed in real-world clinical treatment practice, the increased use of both non-biologic and biologic DMARDS at year two parallels continued improvements in disease activity. However, the overall numbers of improved patients do not necessarily reflect those observed in clinical trials of RA therapy.

Editorial Comments: When complete, this study will provide a wealth of information about the natural history of early synovitis as well as treatment practices in North America. Though preliminary, the year two data demonstrates some interesting points. For one, as no treatment protocol is mandated, the lower ACR responses compared to clinical trials likely represents an overall less aggressive approach to therapy escalation than that encountered in clinical trails of RA therapeutics. Likely, the differences in the SONORA cohort (very early inflammatory synovitis) and those in clinical trials (with early disease often defined as within the first three years of symptoms or diagnosis) may also account for some of these differences. Another interesting point is the continued observation that physicians assessments of improvement are greater than patients, demonstrating that the Physician Global Assessment is comprised primarily of changes in tender + swollen joint counts and inflammatory markers and less on patients views on pain and fatigue.

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