Abstract
ObjectivesThe CAMERA-II trial compared two tight-control, treat-to-target strategies, initiating methotrexate with prednisone (MTX+pred) or MTX with placebo (MTX+plac), in early RA-patients. The multi-biomarker disease activity (MBDA) blood test objectively measures RA disease activity with a score of 1–100. In CAMERA-II, response profiles of the MBDA score, its individual biomarkers, and DAS28 were assessed.MethodsWe evaluated 92 patients from CAMERA-II of whom clinical data and serum for MBDA testing at baseline and ≥ 1 time-point from months 1, 2, 3, 4, 5, 6, 9, or 12 were available. Changes (∆) from baseline for DAS28 and MBDA score and comparisons of ∆DAS28 and ∆MBDA score over time within the MTX+pred versus the MTX+plac strategy were tested for significance with t tests. Changes in biomarker concentration from baseline to months 1–5 were tested with Wilcoxon signed rank test and tested for difference between treatment arms by Mann-Whitney U test.ResultsMBDA and DAS28 showed similar response profiles, with gradual improvement over the first 6 months in the MTX+plac group, and in the MTX+pred group faster improvement during month 1, followed by gradual improvement. The 12 MBDA biomarkers could be grouped into 4 categories of response profiles, with significant responses for 4 biomarkers during the MTX+plac strategy and 9 biomarkers during the MTX+pred strategy.ConclusionsMBDA tracked treatment response in CAMERA-II similarly to DAS28. More individual MBDA biomarkers tracked treatment response to MTX+pred than to MTX+plac. Four response profiles could be observed.Trial registrationCAMERA-II International Standard Randomised Controlled Trial Number: ISRCTN 70365169. Registered on 29 March 2006, retrospectively registered.
Highlights
Rheumatoid arthritis (RA) is a chronic disease of inflammation in synovial joints, resulting in joint damage, physical disability and decreased life span
Whether or not a biomarker responded to MTX+plac, a greater response was usually observed with the addition of prednisone, as seen with C-reactive protein (CRP), Interleukin 6 (IL-6), and VEGF, which decreased in both arms but to a greater degree in the MTX+pred arm
Another category profile was seen with Matrix metalloproteinase 1 (MMP-1), Vascular cell adhesion molecule 1 (VCAM-1), TNF-R1, Cartilage glycoprotein 39 (YKL-40), and leptin, which did not seem to respond to MTX+plac, but did respond to MTX+pred, to prednisone
Summary
Rheumatoid arthritis (RA) is a chronic disease of inflammation in synovial joints, resulting in joint damage, physical disability and decreased life span. In treat-to-target strategies, RA disease activity is quantitatively assessed at regular intervals, and based on pre-specified criteria for treatment response, treatment is adjusted to expeditiously achieve a target of low disease activity or remission [17]. Similar analyses of patients from SWEFOT, a trial of tight control strategies for patients with early RA, found that baseline MBDA score was more strongly associated with radiographic progression than DAS28 or CRP [28]. No study yet evaluated the MBDA response longitudinally at multiple, monthly time points to MTX-based treatment strategies with or without prednisone, such as were applied in the Computer Assisted Management in Early RA Trial-II (CAMERA-II) [29]. In the present sub-study of CAMERA-II, the two strategy arms were compared longitudinally at monthly intervals to determine if the response profiles differed between the MBDA score and DAS28, or among the 12 individual biomarkers of the MBDA score
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