The Multi-biomarker Disease Activity test for assessing response to treatment strategies using methotrexate with or without prednisone in the CAMERA-II Trial
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 timepoint 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.
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 of MTX+pred than of MTX+plac. Four response profiles could be observed.
TRIAL REGISTRATION
CAMERA-II International Standard Randomised Controlled Trial Number: ISRCTN 70365169. Registered 29 March 2006, retrospectively registered.
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Posted 15 Aug, 2020
On 09 Sep, 2020
Received 10 Aug, 2020
On 10 Aug, 2020
Received 09 Aug, 2020
On 06 Aug, 2020
On 06 Aug, 2020
On 05 Aug, 2020
Invitations sent on 05 Aug, 2020
On 04 Aug, 2020
On 04 Aug, 2020
Received 08 Jun, 2020
On 08 Jun, 2020
Received 07 Jun, 2020
On 24 May, 2020
On 21 May, 2020
Invitations sent on 27 Mar, 2020
On 31 Jan, 2020
On 30 Jan, 2020
On 30 Jan, 2020
On 30 Jan, 2020
The Multi-biomarker Disease Activity test for assessing response to treatment strategies using methotrexate with or without prednisone in the CAMERA-II Trial
Posted 15 Aug, 2020
On 09 Sep, 2020
Received 10 Aug, 2020
On 10 Aug, 2020
Received 09 Aug, 2020
On 06 Aug, 2020
On 06 Aug, 2020
On 05 Aug, 2020
Invitations sent on 05 Aug, 2020
On 04 Aug, 2020
On 04 Aug, 2020
Received 08 Jun, 2020
On 08 Jun, 2020
Received 07 Jun, 2020
On 24 May, 2020
On 21 May, 2020
Invitations sent on 27 Mar, 2020
On 31 Jan, 2020
On 30 Jan, 2020
On 30 Jan, 2020
On 30 Jan, 2020
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 timepoint 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.
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 of MTX+pred than of MTX+plac. Four response profiles could be observed.
TRIAL REGISTRATION
CAMERA-II International Standard Randomised Controlled Trial Number: ISRCTN 70365169. Registered 29 March 2006, retrospectively registered.
Figure 1
Figure 2