Abstract

Objective: To validate and compare the definition of the Disease Activity Score 28 based on C-reactive protein (DAS28 [CRP]) to the definition based on erythrocyte sedimentation rate (ESR).

Methods: Data were analyzed from two randomized, double-blind, placebo-controlled trials of abatacept of 6 and 12 months’ duration in patients with rheumatoid arthritis. EULAR response criteria and the proportion of patients in remission (DAS28 <2.6) based on the two DAS28 definitions were examined. Trends in radiographic progression (erosion score, joint-space narrowing score and total score) and physical function (Health Assessment Questionnaire Disability Index [HAQ-DI]) across the EULAR responder states (none, moderate and good) were analyzed.

Results: There was general agreement in determining the EULAR responder state using both DAS28 definitions (kappa=0.80 [95% confidence intervals; CI: 0.76, 0.83]). Overall, there was 82.4% agreement on the EULAR response criteria; when disagreements occurred, the DAS28 (CRP) yielded a better EULAR response more often then DAS28 (ESR) (12.6% vs 4.9%, respectively). There was also agreement in determining remission: kappa=0.69 (95% CI: 0.60, 0.78). Radiographic progression decreased in abatacept-treated patients across EULAR states (from none to moderate to good) based on both definitions. For placebo-treated patients, the trend was not as pronounced, with radiographic scores higher for moderate vs non-responders. For physical function, similar trends were observed across the EULAR states for both DAS28 definitions.

Conclusions: The DAS28 (CRP) has been validated against radiographic progression and physical function. While the DAS28 (CRP) yielded a better EULAR response more often than the DAS28 (ESR), the validation profile was similar to the DAS28 (ESR), indicating that both measures are useful for assessing disease activity in patients with rheumatoid arthritis.