Department of Rheumatology & Clinical Immunology, University Medical Center Utrecht, University of Utrecht, G02.228, PO Box 85500, 3508, GA, Utrecht, The Netherlands.
Novartis Pharma BV, Amsterdam, the Netherlands.
Arthritis Res Ther. 2020 Sep 9;22(1):205. doi: 10.1186/s13075-020-02293-x.
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.
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 (∆) 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.
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.
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.
CAMERA-II International Standard Randomised Controlled Trial Number: ISRCTN 70365169 . Registered on 29 March 2006, retrospectively registered.
CAMERA-II 试验比较了两种严格控制、以目标为导向的治疗策略，即早期 RA 患者起始甲氨蝶呤联合泼尼松（MTX+pred）或 MTX 联合安慰剂（MTX+plac）。多生物标志物疾病活动（MBDA）血液检测通过 1-100 的评分客观地衡量 RA 疾病活动。在 CAMERA-II 中，评估了 MBDA 评分、其各生物标志物和 DAS28 的反应特征。
我们评估了来自 CAMERA-II 的 92 名患者，这些患者在基线时和 1、2、3、4、5、6、9 或 12 个月时至少有一次接受了 MBDA 检测的临床数据和血清。采用 t 检验比较 MTX+pred 与 MTX+plac 策略下 DAS28 和 MBDA 评分的基线变化（∆）以及随时间推移的变化。采用 Wilcoxon 符号秩检验比较基线至 1-5 个月时生物标志物浓度的变化，采用 Mann-Whitney U 检验比较治疗组间的差异。
MBDA 和 DAS28 显示出相似的反应特征，MTX+plac 组在第 6 个月前逐渐改善，MTX+pred 组在第 1 个月改善较快，随后逐渐改善。12 个 MBDA 生物标志物可分为 4 组反应特征，MTX+plac 策略中有 4 个生物标志物有显著反应，MTX+pred 策略中有 9 个生物标志物有显著反应。
MBDA 在 CAMERA-II 中与 DAS28 相似地跟踪治疗反应。与 MTX+pred 相比，MTX+plac 治疗有更多的 MBDA 生物标志物可跟踪治疗反应。可以观察到 4 种反应特征。
CAMERA-II 国际标准随机对照试验编号：ISRCTN70365169。于 2006 年 3 月 29 日注册，回溯性注册。
