The multi-biomarker disease activity test for assessing response to treatment strategies using methotrexate with or with
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(2020) 22:205
RESEARCH ARTICLE
Open Access
The multi-biomarker disease activity test for assessing response to treatment strategies using methotrexate with or without prednisone in the CAMERA-II trial M. S. Jurgens1†, M. Safy-Khan1*† , M. J. H. de Hair2, J. W. J. Bijlsma1, P. M. J. Welsing1, J. Tekstra1, F. P. J. G. Lafeber1, E. H. Sasso3, J. W. G. Jacobs1 and on behalf of the Society for Rheumatology research Utrecht
Abstract Objectives: The 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. Methods: We 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 (Δ) from baseline for DAS28 and MBDA score and comparisons of ΔDAS28 and ΔMBDA 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. Results: MBDA 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. Conclusions: MBDA 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 registration: CAMERA-II International Standard Randomised Controlled Trial Number: ISRCTN 70365169. Registered on 29 March 2006, retrospectively registered. Keywords: Rheumatoid arthritis, Multi-biomarker disease activity score, DAS28, Biomarkers, CAMERA-II
* Correspondence: [email protected] † M. S. Jurgens and M. Safy-Khan contributed equally to this work. 1 Department of Rheumatology & Clinical Immunology, University Medical Center Utrecht, University of Utrecht, G02.228, PO Box 85500, 3508, GA, Utrecht, The Netherlands Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party mater
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