比较多普勒超声与临床缓解标准对RA放射学进展的预测效能

比较多普勒超声与临床缓解标准对RA放射学进展的预测效能

de Miguel, et al. EULAR 2015. Present ID: FRI0586.

原文

译文

FRI0586 DOPPLER ULTRASOUND BETTER PREDICTS X-RAY PROGRESSION IN RHEUMATOID ARTHRITIS THAN ANY DEFINITION OF CLINICAL REMISSION E. de Miguel1,*, E. de Vicente2, F. Diaz Alcazar3, J. L. de la Iglesia4, M. L. Garcia Vivar5, J. Uson Jaeger6, J. Ivorra7, J. L. Rivas8 1Rheumatology Dept, Hospital La Paz, 2Rheumatology Dept, Hospital La Princesa, Madrid, 3Rheumatology Dept, Hospital Galdakao, Usansolo, 4Rheumatology Dept, Hospital de Jerez, Jerez de la Frontera, 5Rheumatology Dept, Hospital de Basurto, Bilbao, 6Rheumatology Dept, Hospital de Mostoles, Mostoles, 7Rheumatology Dept, Hospital La Fe, Valencia, 8Medical Dept, AbbVie Spain, Madrid, Spain Background: Clinical remission is the treatment target for patients with rheumatoid arthritis (RA). However, different definitions have been proposed. Still, damage and/or subclinical inflammation (eg, positive Doppler signal) may persist despite apparent clinical remission Objectives: To examine the validity of different definitions of remission and Doppler ultrasound using X-Ray progression as the gold standard Methods: Data were obtained from an observational, prospective, multicenter study in RA patients with moderate disease activity (3.2≤DAS28(CRP)≤5.1) who started anti-TNF therapy, conducted under conditions of daily practice. At recruitment and at months 6 and 12, patients were scheduled for a clinical examination, laboratory data collection and reduced 12-joints Power Doppler (PD) ultrasound examination of the wrist, 2nd and 3rd MCP, elbow, knee, and ankle bilateral joints. Synovitis grey scale and PD counts were obtained, and each joint was semi-quantitatively assessed (0 – 3) to obtain grey scale synovitis and PD scores. DAS28 (ESR/CRP), SDAI, CDAI, and ACR/EULAR remission criteria were collected. At baseline and month 12, radiographs of hands and feet were obtained and assessed by an independent observer in pairwise, chronological order and scored according to Sharp-van der Heijde method. X-Ray progression was defined as an increase >1 point and non-progression as ≤0. Patients with doubtful X-ray progression (progression = 1), were excluded from independent tests of X-ray progression and US findings Results: The sample consisted of 129 patients, 107 women (82.9%), with median (IQR) age of 56.0 (44.0-66.0) years, median time from diagnosis of 5.0 (3.0-11.5) years, and positive rheumatoid factor in 82 patients (63.6%). At 12 months, Sharp-van der Heijde's score median increase was 3.0 (0.0-6.5) points, with 36 patients not progressing and 79 with progression (14 patients with doubtful X-ray progression). Remission rates at 6 and 12 months according to different clinical criteria were: CDAI, 10.5% and 15.9%, SDAI, 12.3% and 15.7%; ACR/EULAR, 12.6% and 14.2%, DAS28ESR, 21.1% and 33.9%; DAS28CRP, 45.9% and 56.7%, respectively. Disease activity at any study time by any composite index (DAS28ESR, DAS28CRP, SDAI, CDAI and ACR/EULAR) was not significantly associated with X-Ray progression. PD score ≥1 at baseline and persistence of PD score ≥1 at 6 months were associated with X-Ray progression: OR= 5.067 (IC95%: 1.162 – 21.576; p=0.017), and OR=7.474 (IC95%: 2.644 – 21.123; p < 0.0005), respectively. Conclusions: A short 12 joints PD US score shows better predictive validity for structural damage progression in RA than composite indices of disease activity. PD signal, but not clinical disease activity, can predict X-ray progression at 6 and 12 months. Probably in the near future Ultrasound may need to be considered as a component of RA remission criteria. Acknowledgements: The authors wish to thank Jesus Garrido for providing medical writing and editing services in the development of this abstract and poster. The financial support for these services was provided by AbbVie. Disclosure of Interest: E. de Miguel Grant/research support from: AbbVie, E. de Vicente Grant/research support from: AbbVie, F. Diaz Alcazar Grant/research support from: AbbVie, J. de la Iglesia Grant/research support from: AbbVie, M. L. Garcia Vivar Grant/research support from: AbbVie, J. Uson Jaeger Grant/research support from: AbbVie, J. Ivorra Grant/research support from: AbbVie, J. Rivas Employee of: AbbVie DOI: 10.1136/annrheumdis-2015-eular.5223

背景：临床缓解是类风湿关节炎(RA)的治疗目标。然而, 有多种不同的定义被提出。然而, 在那些临床缓解很明显的患者中关节破坏和/或亚临床炎症(例如多普勒信号阳性)仍持续存在。 目的: 以X线进展为金标准检验不同缓解定义与多普勒超声的有效性。 方法：数据来自一项观察性、前瞻性、多中心研究, 在常规诊疗条件下, 中度活动RA患者(3.2≤DAS28CRP≤5.1)接受抗TNF治疗。在招募时以及第6和12个月时, 患者定期进行临床检查并收集化验数据, 并按照简化的12关节行多普勒超声检查, 包括双腕、双侧第二和第三MCP、双肘、双膝和双踝。获取上述每个关节滑膜炎的灰阶和PD信号, 均采用半定量评估(0-3)。收集DAS28(ESR/CRP)、SDAI、CDAI以及 ACR & EULAR定义的缓解数据。在基线和第12个月, 有一名独立阅片师按照van de Heijde改良的Sharp评分对按时间顺序排列、成对的手足X线摄片进行评估。X线进展的定义: 改良Sharp总评分自基线增加>1。X线无进展的定义为总评分自基线变化≤0。X线进展被判可疑(进展变化=1)的患者被不能纳入X线进展以及超声相关的独立检验。 结果: 样本包括129例RA患者, 女性107例(82.9％), 中位数年龄(IQR)为56.0岁(44.0-66.0), 确诊后病程中位数为5.0年(3.0-11.5), 类风湿因子阳性有82患者(63.6％)。随访至12个月时, 改良Sharp评分增加3.0(0.0-6.5), 有36例放射学无进展, 79例为放射学进展(14例为可疑X线进展)。根据不同定义, 第6和12个月的缓解率分别为: CDAI-10.5％和15.9％, SDAI-12.3％和15.7％, ACR/EULAR- 12.6％和14.2％, DAS28ESR-21.1％和33.9％, DAS28CRP-45.9％和56.7％。在任一随访点, 所有临床标准定义的缓解(DAS28ESR, DAS28CRP, SDAI, CDAI和ACR/EULAR)均与X线进展没有相关性。 基线PD评分≥1以及第6个月PD评分也≥1分别与X线进展有显著关联性(前者OR=5.067(95％CI: 1.162 - 21.576, P=0.017, 后者OR=7.474(95％CI: 2.644 - 21.123, P <0.0005)。 结论：本研究发现, 简化12关节多普勒超声评分相较于临床复合指标对第12个月X线进展有更好的预测效度。在不久的将来, 可能会考虑将超声列入缓解标准中的一个参数。