Clinical Immunology and Rheumatology, Amsterdam Rheumatology & Immunology Center and Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands.
UCB Pharma, Monheim, Germany.
Arthritis Res Ther. 2018 Sep 14;20(1):209. doi: 10.1186/s13075-018-1707-8.
To be eligible to receive treatment with an anti-tumour necrosis factor (TNF), non-radiographic axial spondyloarthritis (nr-axSpA) patients require either elevated levels of C-reactive protein (CRP) (CRP > upper limit of normal (ULN)) or magnetic resonance imaging assessment showing inflammation of the sacroiliac joints, in addition to meeting criteria for high disease activity. Many axSpA patients are classified as 'CRP-negative', or CRP normal, despite having levels close to the ULN, and are therefore formally ineligible for treatment. The aim of this study was to investigate the likelihood of a CRP test indicating elevated levels in axSpA patients that have previously tested CRP normal.
RAPID-axSpA (NCT01087762) enrolled patients who were either magnetic resonance imaging positive or had elevated CRP (> ULN: 7.9 mg/L). CRP data from the double-blind period for placebo-randomised patients until re-randomisation to certolizumab pegol (week 16 for ASAS20 non-responders/week 24 for ASAS20 responders) were analysed. CRP was assessed at screening, baseline, and nine time points to week 24. Linear mixed models were used to investigate time trends, variability, and correlations of CRP data.
Of 106 placebo-randomised patients with baseline CRP assessments, 26 (25%) tested CRP normal at baseline, of whom 13 (50%) had ≥ 1 test indicating elevated CRP to week 16. Of 80/106 (75%) patients with elevated baseline CRP, 25 (31%) had ≥ 1 normal CRP test to week 16. Linear mixed models did not reveal changes in mean CRP across placebo patients from baseline to week 24.
In axSpA patients with CRP < ULN the CRP test should be repeated after ≥ 4 weeks as there is a substantial chance of finding a positive result for elevated CRP at subsequent testing, thereby allowing the patient access to treatment.
ClinicalTrials.gov, NCT01087762 . Registered on 16 March 2010.
为了有资格接受抗肿瘤坏死因子（TNF）治疗，非放射性轴性脊柱关节炎（nr-axSpA）患者除符合高疾病活动度标准外，还需要 C 反应蛋白（CRP）水平升高（CRP>正常值上限（ULN））或磁共振成像评估显示骶髂关节炎症。许多 axSpA 患者被归类为“CRP 阴性”或 CRP 正常，尽管其水平接近 ULN，但因此正式不符合治疗条件。本研究旨在调查 CRP 检测在以前 CRP 正常的 axSpA 患者中提示 CRP 水平升高的可能性。
RAPID-axSpA（NCT01087762）入组了磁共振成像阳性或 CRP 升高（>ULN：7.9mg/L）的患者。对安慰剂随机分组患者的双盲期至重新随机分组为 certolizumab pegol（ASAS20 无应答者为第 16 周，ASAS20 应答者为第 24 周）的数据进行分析。在筛查、基线和第 9 次至第 24 次就诊时评估 CRP。采用线性混合模型分析 CRP 数据的时间趋势、变异性和相关性。
在 106 例基线 CRP 评估的安慰剂随机分组患者中，26 例（25%）基线时 CRP 正常，其中 13 例（50%）至第 16 周时有≥1 次 CRP 升高检测结果。在 80/106（75%）基线 CRP 升高的患者中，25 例（31%）至第 16 周时有≥1 次 CRP 正常检测结果。线性混合模型显示安慰剂患者的平均 CRP 从基线到第 24 周没有变化。
在 CRP<ULN 的 axSpA 患者中，应在≥4 周后重复 CRP 检测，因为在随后的检测中发现 CRP 升高的阳性结果的可能性很大，从而使患者能够接受治疗。
ClinicalTrials.gov，NCT01087762。于 2010 年 3 月 16 日注册。
