Background/Purpose: Clinical evidence has established the importance of early, intensive treatment of rheumatoid arthritis (RA) to decrease disease activity and prevent joint damage.¹ The objective of this analysis is to examine the relationships between disease activity and inhibition of radiographic progression after 36 weeks of etanercept (ETN) + methotrexate (MTX) therapy in patients with moderate RA.

Methods: In the PRESERVE trial, patients with moderately active RA (DAS28 3.2–5.1) despite stable MTX for ≥3 months received open-label ETN 50 mg once weekly + MTX for 36 weeks. Week 36 (final time point) mTSS, defined as the sum of baseline mTSS and mTSS progression rate (units/year), was analyzed in relationship to disease activity by CDAI and DAS28.   

Results:   704 patients who received ≥1 dose of ETN 50 mg + MTX and had available X-rays were included in this analysis. The percentage of patients achieving CDAI and DAS28 remission was 28% and 69%, respectively, and LDA including remission was seen in 87% and 88%. Both week 36 CDAI and week 36 DAS28 remitters had lower week 36 mTSS progression rate (units/year) compared with non-remitters (P<0.05). Week 36 CDAI remitters also had lower baseline mTSS and lower week 36 mTSS (P<0.05; Table). CDAI and DAS28 week 36 disease activity categories (remission, LDA excluding remission, and NR) had similar proportions of patients (~80–87%) who achieved radiographic non-progression (mTSS Δ ≤0.5). A significant relationship (P<0.001) was observed between baseline mTSS quartiles and week 36 mTSS progression rate categories (≤0.5, >0.5≤3, >3); the lowest baseline mTSS quartile (≤5) had the highest proportion of non-progressors (≤0.5; 28%) and the highest quartile (>51) yielded the highest percentage (54%) of patients with large radiographic progression (>3). A similar, significant (P<0.01) relationship was seen between baseline mTSS quartiles and week 36 CDAI response categories, with the lowest quartile having the highest proportion of CDAI remitters (33%) and highest quartile having the largest proportion of CDAI NR (31%).

Conclusion: A large proportion of patients treated with ETN+MTX achieved remission as measured by CDAI and DAS28 which inhibited radiographic progression regardless of week 36 disease activity. Overall, patients had less radiographic progression if they also achieved remission compared to LDA or NR. These results indicate that achievement of clinical goals in moderate RA has implications for structural benefits.

Reference: 1. Combe B. Best Pract Res Clin Rheumatol. 2007;21:27–42.