A10.22 Response to MTX Plus Prednisone in Camera II Using a Multi-Biomarker Disease Activity (Vectra™DA) TEST and DAS28-ESR
Background and Objectives The CAMERA II study (Computer Assisted Management in Early RA) demonstrated that the addition of prednisone versus placebo to a MTX-based tight-control strategy increased effectiveness of therapy and reduced need for biological treatment. The present study evaluated changes...
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Published in | Annals of the rheumatic diseases Vol. 72; no. Suppl 1; p. A80 |
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Main Authors | , , , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
BMJ Publishing Group Ltd and European League Against Rheumatism
01.03.2013
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Online Access | Get full text |
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Summary: | Background and Objectives The CAMERA II study (Computer Assisted Management in Early RA) demonstrated that the addition of prednisone versus placebo to a MTX-based tight-control strategy increased effectiveness of therapy and reduced need for biological treatment. The present study evaluated changes in biomarker levels over time with MTX+placebo and MTX+prednisone treatment, using the Multi-Biomarker Disease Activity (MBDA) blood test. Materials and Methods Clinical and biomarker assessments were performed at monthly visits to 1 year for 92 patients who had MBDA test results available at baseline and ≥1 subsequent visit. Average number of visits with non-missing disease activity measures was 3.7 per patient. Concentrations of 12 serum biomarkers were combined to produce a score between 1 and 100 using the MBDA algorithm, which generates a validated measure of disease activity. Biomarker responses were also assessed individually but only to 5 months, to avoid subsequent protocol-mandated exposures to non-MTX DMARDs for insufficient responders. Association between DAS28-ESR response and MBDA response was assessed using Spearman’s correlation. Changes from baseline and comparisons of change over time for MTX+placebo versus MTX+prednisone were analysed by t-tests. Biomarker concentrations were analysed as fractions relative to baseline using Mann Whitney U tests. Results Changes from baseline to 1 year in DAS28-ESR and MBDA scores showed a significant correlation in the MTX+placebo arm (r = 0.57, p < 0.001, n = 31) and the MTX+prednisone arm (r = 0.57, p = 0.002, n = 28). Improvements in DAS28-ESR (p < 0.001) and MBDA (p = 0.01) scores were observed as early as 1 month post-BL in the MTX+prednisone arm. Significant reduction in disease activity in the MTX+placebo arm was first observed at 2 months for DAS28-ESR (p = 0.02) and 4 months for MBDA (p = 0.03). Overall, DAS28-ESR and MBDA response profiles were similar, with mean changes at month 5 for MTX+placebo and MTX+prednisone being –2.2/–4.2 for DAS28-ESR, and –13/–21 for MBDA score. Individual biomarker response profiles differed: for some biomarkers, MTX+placebo had little/no effect but MTX+prednisone had significant effect (e.g., MMP-1, TNF-R1, VCAM-1); for others, MTX+placebo had a significant effect that was augmented (e.g., CRP, IL-6, VEGF) or not affected (SAA) by prednisone. Conclusions Responses assessed with the biomarker-based MBDA test and DAS28-ESR were greater and more rapid for therapy with MTX+prednisone than MTX+placebo, even though individual biomarkers differed in their response profiles. The MBDA test may be useful in combination with clinical assessment to evaluate early response to therapy with MTX or MTX+prednisone. |
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Bibliography: | href:annrheumdis-72-A80-1.pdf ArticleID:annrheumdis-2013-203224.22 ark:/67375/NVC-VVG3HM5X-B istex:BEE4A6F0DCA4E3599A032994BF20C7D0E55D68A7 local:annrheumdis;72/Suppl_1/A80-a |
ISSN: | 0003-4967 1468-2060 |
DOI: | 10.1136/annrheumdis-2013-203224.22 |