原文

译文

THU0464

COMPARABLE LEVELS OF DISEASE ACTIVITY BETWEEN AXIAL SPONDYLOARTHRITIS PATIENTS CLASSIFIED THROUGH THE MRI OR HLA-B27 PATHWAY OF THE ASAS CRITERIA

J. Sieper ^1,*, D. van der Heijde ², M. Dougados ³, P. Mease ⁴, A. L. Pangan ⁵

¹Charité Universitätsmedizin, Berlin, Germany, ²Leiden Univ. Medical Centre, Leiden, Netherlands, ³Hospital Cochin, Paris, France, ⁴Swedish Medical Center, Seattle, ⁵Abbott, Abbott Park, United States

Background: ASAS has validated new classification criteria for patients (pts) with axial spondyloarthritis (SpA) that also capture pts who fulfill the modified New York (mod NY) criteria for ankylosing spondylitis (AS).¹ Adalimumab (ADA) is indicated for the treatment of AS. ABILITY I, an ongoing randomized controlled trial of ADA, is the first pivotal study using the new ASAS axial SpA criteria.

Objectives: To characterize non-AS axial SpA pts enrolled using the new ASAS axial SpA criteria.

Methods: ABILITY I pts fulfilled the ASAS axial SpA criteria but not mod NY criteria for AS, and did not have a prior diagnosis of psoriasis. A pt could fulfill the criteria through 2 arms: an MRI positive for sacroiliitis plus ≥1 other SpA feature, or a positive HLA-B27 screening plus ≥2 other SpA features. The SpA features include: inflammatory back pain, good prior response to NSAIDs, family history of SpA, elevated CRP, positive HLA-B27, and past or present arthritis, heel enthesitis, anterior uveitis (AU), dactylitis, psoriasis, or inflammatory bowel disease. BASDAI ≥4 and total back pain (TBP) ≥40 mm were required at study entry.

Results: ABILITY I enrolled 192 pts in Europe, Canada, Australia, and the U.S. Ninety-four pts (49%) fulfilled the MRI arm, 54 of whom (28% of total, 57% of MRI subgroup) were HLA-B27+, while 96 pts (50%) with negative MRI fulfilled the HLA-B27+ path. Across all subgroups, the most frequently reported SpA features were inflammatory back pain and good prior response to NSAIDs (table).  A higher proportion of HLA-B27+ pts reported family history of SpA and AU. Regardless of the ASAS criteria pathway, baseline disease activity was comparable across all mutually exclusive subgroups. A delay in diagnosis was noted given the duration of symptoms and time since diagnosis. Compared to AS pts in the ATLAS trial, the ABILITY I population had more females, was younger, and had a more recent diagnosis, yet similar levels of disease activity.² Baseline BASDAI and TBP scores from ATLAS were 6.3 and 65.3.³

Conclusions: Non-AS axial SpA pts in ABILITY I had similar levels of disease activity and associated SpA features regardless of which arm of the ASAS criteria they fulfilled.  However, HLA-B27+ pts were more likely to have a family history of SpA and anterior uveitis.

References: 1. Rudwaleit et al. Ann Rheum Dis 2009;68:777–83 2. van der Heijde et al. Arthritis Rheum 2006; 54:2136-46 3. Sieper et al. 74^th ACR Annual Scientific Meeting [P559]; 7-11 Nov 2010, Atlanta, US

中轴型SpA的两种诊断分支具有可比性

Sieper J, et al. EULAR 2011. Present No: THU0464.

背景：ASAS已经验证了中轴型SpA分类标准，该分类标准也涵盖了符合纽约改良版分类标准的强直性脊柱炎(AS)病人[1]。ABILITY-I是一项进行中的TNF拮抗剂治疗SpA的随机对照临床试验，这项探索性研究首次使用了ASAS新版中轴型SpA分类标准。

目的：对符合ASAS新版中轴型SpA分类标准的非AS的SpA病人特征进行研究。

方法：该临床试验入组条件是病人符合ASAS新版中轴型SpA分类标准但不符合纽约改良版AS分类标准，无银屑病既往史。ASAS中轴型SpA的两个诊断分支均可纳入病人：MRI骶髂关节炎阳性再加至少1项SpA特征，或者HLA-B27阳性再加至少2项SpA特征。SpA特征包括炎性背痛、NSAIDs有效、SpA家族史、CRP升高、HLA-B27阳性、现患关节炎或有关节炎既往史、跟腱炎、眼前段葡萄膜炎(AU)、指趾炎、银屑病或炎性肠病。入组条件还包括：BASDAI≥4且总体背痛(TBP)≥40mm。

结果：该试验在欧洲、加拿大、澳大利亚和美国共入组192例病人。符合MRI诊断分支的有94例(49%)，其中54例为HLA-B27阳性(在总体病人群所占比例为28%, 在MRI分支组中比例为57%)，96例(50%)符合HLA-B27诊断分支且MRI检查为阴性。分析所有亚组发现最常报告的SpA特征是炎性背痛以及既往NSAIDs有效HLA-B27阳性病人有SpA家族史和AU的比例也较高。不论使用哪个ASAS诊断分支，互不重叠的亚组病人的基线活动度相似。考察症状持续时间和诊断时间则发现诊断有延迟。与ATLAS临床试验相比，ABILITY-I试验人群女性患者比例高一些，更年轻，更多近期发病患者，而疾病活动度相近[2]。ATLAS试验的基线BASDAI和TBP评分均值分别为6.3和65.3[3]。

结论：ABILITY-I试验中非AS的中轴型SpA患者中符合ASAS新版分类标准任一分支的亚组病人有着相似的基线疾病活动度且SpA特征也相似。然而HLA-B27病人更可能有SpA家族史和前段葡萄膜炎。

Table – Baseline Axial SpA Features, Demographics, and Disease Characteristics*

* Preliminary  data; ^# 2/192 pts were found to have negative MRI and HLA-B27 post-randomization

表. 中轴型SpA基线特征、人口统计学以及疾病特征

* 初级数据; ^# 2/192病人的MRI和HLA-B27均阴性。