Fleischmann Roy M, van der Heijde Désirée, Gardiner Philip V, Szumski Annette, Marshall Lisa, Bananis Eustratios
University of Texas , Dallas, Texas , USA.
Leiden University Medical Center , Leiden , The Netherlands.
RMD Open. 2017 Jan 30;3(1):e000382. doi: 10.1136/rmdopen-2016-000382. eCollection 2017.
In most patients with rheumatoid arthritis (RA), Disease Activity Score 28-joint count C reactive protein (DAS28-CRP) is lower than DAS28 erythrocyte sedimentation rate (DAS28-ESR), suggesting that use of the DAS28-ESR cut-off to assess high disease activity (HDA) with DAS28-CRP may underestimate the number of patients with HDA. We determined the DAS28-CRP value corresponding to the validated DAS28-ESR cut-off for HDA.
Baseline data were pooled from 2 clinical studies evaluating etanercept (ETN) plus methotrexate (MTX) or MTX in early RA; DAS28-CRP and DAS28-ESR were obtained, allowing the determination of the DAS28-CRP HDA value best corresponding to the DAS28-ESR cut-off of >5.1.
At baseline, as expected, fewer patients had HDA by DAS28-CRP than DAS28-ESR; DAS28-CRP>5.1 and DAS28-ESR>5.1 had only modest agreement (κ coefficients 0.45-0.54). Mean DAS28-CRP and DAS28-ESR were 5.7 and 6.2, respectively, in the ETN+MTX group (n=571), and 6.0 and 6.5 in the MTX group (n=262). A DAS28-CRP cut-off of 4.6 corresponded to a DAS28-ESR cut-off of 5.1.
We have shown that a DAS28-CRP of 4.6 corresponds to 5.1 for DAS28-ESR. Since this is substantially lower than the DAS28-ESR cut-off of 5.1, using 5.1 as the cut-off for DAS28-CRP underestimates disease activity in RA.
NCT00195494; NCT00913458.
在大多数类风湿关节炎(RA)患者中,28关节疾病活动评分C反应蛋白(DAS28-CRP)低于28关节疾病活动评分红细胞沉降率(DAS28-ESR),这表明使用DAS28-ESR临界值来评估DAS28-CRP的高疾病活动度(HDA)可能会低估HDA患者的数量。我们确定了与已验证的用于HDA的DAS28-ESR临界值相对应的DAS28-CRP值。
汇总两项评估依那西普(ETN)加甲氨蝶呤(MTX)或MTX治疗早期RA的临床研究的基线数据;获取DAS28-CRP和DAS28-ESR,从而确定最符合DAS28-ESR临界值>5.1的DAS28-CRP HDA值。
在基线时,正如预期的那样,通过DAS28-CRP诊断为HDA的患者比通过DAS28-ESR诊断的患者少;DAS28-CRP>5.1和DAS28-ESR>5.1之间仅有适度的一致性(κ系数为0.45-0.54)。在ETN+MTX组(n=571)中,DAS28-CRP和DAS28-ESR的平均值分别为5.7和6.2,在MTX组(n=262)中分别为6.0和6.5。DAS28-CRP临界值4.6对应于DAS28-ESR临界值5.1。
我们已经表明,DAS28-CRP为4.6对应于DAS28-ESR为5.1。由于这显著低于DAS28-ESR临界值5.1,将5.1用作DAS28-CRP的临界值会低估RA的疾病活动度。
NCT00195494;NCT00913458。